Outpatient cervical ripening before first-trimester surgical abortion: a comparison between misoprostol and isosorbide mononitrate. Preinduction cervical ripening: prostaglandin E2 gel vs hygroscopic mechanical dilator. A randomized comparison of sublingual and vaginal misoprostol for cervical priming before suction termination of first-trimester pregnancy. Sublingual misoprostol before first trimester abortion: a comparative study using two dose regimens. Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Preinduction cervical ripening techniques compared. Sublingual misoprostol for preabortion cervical ripening in first-trimester pregnancy termination. Preinduction cervical ripening. A randomized trial of intravaginal misoprostol alone vs. a combination of transcervical Foley balloon and intravaginal misoprostol. Effect of misoprostol for cervical ripening prior to pregnancy interruption before twelve weeks of gestation. Randomised controlled study comparing oral and vaginal misoprostol for cervical priming prior to surgical termination of pregnancy. Gemeprost versus misoprostol for cervical priming before first-trimester abortion: a randomized controlled trial. Vaginal misoprostol for pre-abortion cervical priming: is there an optimal evacuation time interval? Cervical priming with sublingual misoprostol vs. 15-methyl-prostaglandin F2alpha prior to surgical abortion. Nitric oxide donors induce ripening of the human uterine cervix: a randomised controlled trial. Sublingual versus vaginal misoprostol (400 microg) for cervical priming in first-trimester abortion: a randomized trial. Oral versus vaginal misoprostol for cervical priming in first-trimester abortion: a randomized trial. Comparison of oral and vaginal misoprostol for cervical ripening before manual vacuum aspiration of first trimester pregnancy under local anesthesia: a randomized placebo-controlled study. A randomized study comparing the use of sublingual to vaginal misoprostol for pre-operative cervical priming prior to surgical termination of pregnancy in the first trimester. Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study. The use of oral misoprostol for pre-abortion cervical priming: a randomised controlled trial of 400 versus 200 microg in first trimester pregnancies. Cervical ripening before induction of labour in patients with an unfavourable cervix: a comparative randomized study of the Atad Ripener Device, prostaglandin E2 vaginal pessary, and prostaglandin E2 intracervical gel. Vaginal vs. sublingual misoprostol with mifepristone for cervical priming in second-trimester abortion by dilation and evacuation: a randomized clinical trial. The use of misoprostol for pre-operative cervical dilatation prior to vacuum aspiration: a randomized trial. A randomized trial of laminaria tents versus vaginal misoprostol for cervical ripening in first trimester surgical abortion. Cervical dilatation with 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (Cervagem) prior to vacuum aspiration. A double-blind, placebo-controlled randomized study. Cervical preparation using laminaria with adjunctive buccal misoprostol before second-trimester dilation and evacuation procedures: a randomized clinical trial. Prostaglandin E2 gel versus misoprostol for cervical ripening in patients with premature rupture of membranes after 34 weeks. A comparison of isosorbide mononitrate and misoprostol cervical ripening before suction evacuation. [Cervical ripening : comparison of three methods. Preliminary results of a randomized prospective study]. Cervical ripening and induction of labor with misoprostol, dinoprostone gel, and a Foley catheter: a randomized trial of 3 techniques. Preinduction cervical ripening with intravaginal prostaglandin E1 methyl analogue misoprostol: a randomized controlled trial. A randomized controlled comparison of sublingual and vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion. A randomized controlled trial of laminaria, oral misoprostol, and vaginal misoprostol before abortion. Induced cervical ripening with Mifepristone in first trimester abortion. A double-blind randomized biomechanical study. Cervical ripening and induction of delivery by local administration of prostaglandin E2 gel or vaginal tablets is equally effective. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception. Second-trimester pregnancy termination: comparison of three different methods. Oral misoprostol versus vaginal gemeprost for cervical dilatation prior to vacuum aspiration in women in the sixth to twelfth week of gestation. Oral versus self-administered vaginal misoprostol at home before surgical termination of pregnancy: a randomised controlled trial. A double-blind randomized trial of two dose regimens of misoprostol for cervical ripening and labor induction. Oral misoprostol versus placebo for cervical dilatation before vacuum aspiration in first trimester pregnancy. Randomized controlled trial of misoprostol for second-trimester pregnancy termination associated with fetal malformation. Cervical priming with prostaglandin E1 analogues, misoprostol and gemeprost. Preinduction cervical ripening: a randomized prospective comparison of the efficacy and safety of intravaginal and intracervical prostaglandin E2 gel. Outpatient cervical ripening with intravaginal misoprostol. A comparison of osmotic dilators, Lamicel and Dilapan, and a prostaglandin E1 analogue, gemeprost, for ripening the cervix before legal abortion.
Vaginal administration of prostaglandin analogues as well as nitric oxide donors before first-trimester surgical abortion has been shown to induce effective cervical ripening. In addition, nitric oxide donors, such as isosorbide mononitrate and nitroglycerin, have been associated with a patient-friendly side-effect profile when administered 3 h before the surgical procedure. We wanted to compare the cervical ripening effect and possible side effects of isosorbide mononitrate and the prostaglandin analogue misoprostol when self-administered at bedtime the evening before surgical abortion.
                One hundred and twenty nulliparous women scheduled for suction termination of pregnancy in the first trimester were randomly assigned to receive per vaginam either 40 mg of isosorbide mononitrate or 200 microg of misoprostol. Sixty of the women were included for assessment of cervical ripening as well as evaluation of side effects. The other 60 women were recruited for assessment of side effects only. Cervical ripening was evaluated by measuring baseline cervical dilation and the cumulative force to dilate the cervix to 9 mm by means of a cervical tonometer. For assessment of side effects, the women were asked to complete a symptom questionnaire.
                Cervical resistance was significantly higher in women treated with isosorbide mononitrate compared to misoprostol (median cumulative force 73 versus 15 N). Common side effects of misoprostol were abdominal pain (69%), nausea (44%), and vaginal bleeding (66%), while in the isosorbide mononitrate group headache was frequently experienced (79%). In both treatment groups, the frequency and intensity of side effects gradually increased during the treatment interval.
                Misoprostol induced a more pronounced cervical ripening than isosorbide mononitrate, but both regimens were associated with a high frequency of side effects. To evaluate the efficacy and safety of hygroscopic mechanical dilators (Dilapan) for ripening the pregnant cervix prior to induction of labour at or near term and to compare it with an intracervical PGE2 gel (Prepidil).
                One hundred and eighty-five women (69 nulliparae, 116 multiparae) at term with singleton pregnancies in cephalic presentation, who were scheduled for induction of labour in the labour ward at the National University Hospital, but had an unfavourable cervical score were randomized into 2 groups by random number table. In group 1 (Prepidil), 0.5 mg of PGE2 in 2.5 ml of triacetin gel was inserted into the endocervical canal. In women in group 2 (Dilapan) upto a maximum of 4 hygroscopic dilators were placed in the endocervical canal. If labour did not ensue at the end of 12 hours of ripening, the cervical score was assessed, amniotomy was performed and oxytocin commenced. Neonatal and obstetric outcome was compared, statistical analysis performed using Chi-square, and t-tests.
                Significantly more women in the group who received Dilapan for cervical ripening required amniotomy and oxytocin for induction of labour > 12 hours after priming compared with the group who received Prepidil (p < 0.001). Operative delivery for no progress and fetal distress respectively was similar in the 2 groups. The number of cases of hyperstimulation were higher in the Prepidil group but did not result in an increased incidence of operative deliveries for fetal distress. There was one neonatal death and one case of neonatal sepsis in the Dilapan group. Uterine rupture occurred in 1 woman who received Prepidil.
                Dilapan, a mechanical method of cervical ripening is as effective as the more widely accepted mode of ripening with an endocervical PGE2 gel in achieving vaginal delivery. Dilapan would be useful for cervical priming prior to induction of labour in places where prostaglandins are not available because of cost and the need for a cold chain. This randomized trial compares the efficacy and side effects of sublingual and vaginal misoprostol for cervical priming before first-trimester pregnancy termination. One-hundred pregnant women between 6 and 12 weeks of gestation opting for termination of pregnancy by suction evacuation were included in this study. The women were randomly allocated into two groups. Group 1 received 400 microg of sublingual misoprostol and group 2 received 400 microg of vaginal misoprostol 2 h prior to suction evacuation. The abortion was carried out by suction evacuation using a Karman's cannula attached to an electrically operated suction machine under intravenous analgesia. Baseline cervical dilatation, duration of the procedure, operative blood loss, side effects and complications were noted in both groups. There was a significant difference between the sublingual and vaginal misoprostol groups with respect to mean cervical dilatation (8.6 mm vs. 6.8 mm, p < 0.05). However, the duration of the procedure (3.03 min vs. 3.16 min) and the amount of blood loss (29 mL vs. 31.2 mL) were not significantly different between the two groups. The women in the sublingual group experienced significantly more shivering and preoperative vaginal bleeding (68% vs. 56%, p < 0.05). None of the women in the two groups had either uterine perforation or excessive hemorrhage. In our study, sublingual misoprostol (400 microg) was significantly more effective in facilitating cervical dilation prior to surgical abortion than vaginal misoprostol. Various methods have been described for preoperative cervical priming prior to vacuum aspiration (VA) in first trimester pregnancy termination, to facilitate cervical dilatation and shorten the abortion procedure. Recently misoprostol a prostaglandin E1 analogue has been shown to be effective in facilitating cervical dilatation prior to VA. Misoprostol offers several advantages over the other prostagland in analogues including stability at room temperature, ease of administration and minimal side effects.
                To determine the optimal dosage and dosing interval for the use of misoprostol administered sublingually for pre-abortion cervical dilatation.
                This was a prospective randomised study conducted at Comprehensive Rural Health Project, Ballabgarh the rural health centre under Centre for Community Medicine, AIIMS, New Delhi.
                One hundred and twenty pregnant women between 6-11 weeks of gestation opting for voluntary medical termination of pregnancy were (MTP) randomly allocated to either 200 microg or the 400 microg misoprostol group. Vacuum aspiration was performed either two or three hours after administration of sublingual misoprostol. Using Hegar's dilators, degree of cervical dilatation before vacuum aspiration was measured. Other parameters assessed included the amount of additional dilatation required, intra-operative blood loss and associated side effects.
                Statistical analysis was conducted using chisquare, the student's t and the Mann-Whitney U tests to examine the difference between the two groups.
                In the 200 microg misoprostol group 33% achieved a dilatation of > or = 8 mm compared with 71% of women in the 400 microg misoprostol group. The odds ratio was 95.8 (95% CI 10.2-842.9) for 400 microg misoprostol for successful preoperative cervical dilatation of > or = 8 mm. The mean baseline cervical dilatation for 400 microg and 200 microg misoprostol was 8.2 mm and 6.0 mm respectively (P < 0.001). The use of 400 mg misoprostol with an evacuation interval of two hours appears to be the optimal dosage and evacuation interval. Increasing the time interval beyond two hours did not confer any additional advantage on the rate of successful cervical dilatation but was instead associated with an increased incidence of side effects such as preoperative vaginal bleeding, abdominal pain and shivering.
                Our study has shown that Sublingual administration of 400 microg of misoprostol at least two hours before procedure is effective for preoperative cervical dilatation before vacuum aspiration in first trimester pregnancy termination. There is no additional advantages of increasing the dosing interval upto three hours. Misoprostol is being used increasingly in clinical practice for cervical ripening in first-trimester abortions, but because of lack of good evidence of its effectiveness, administration consensus has not been reached on dosage, route of administration, time of administration pre-operatively and gestational age group. In this study we tested the hypothesis that self-administration of 600 micrograms vaginal misoprostol is feasible and when used 2-4 hours pre-operatively results in sufficient cervical dilatation to make suction curettage easier.
                A double-blind, randomised, placebo-controlled trial was undertaken. Two hundred and seventy-eight women scheduled for termination of pregnancy of up to 12 weeks' duration by manual vacuum aspiration were assigned to receive either 600 micrograms misoprostol pre-operatively, or placebo. The achievement of 'satisfactory' (> or = 7 mm) baseline cervical dilatation after 2-4 hours was evaluated as the primary outcome. Secondary outcome measurements included ease and duration of the procedure. Side-effects such as pre-operative bleeding, gastro-intestinal complaints and pain as well as adverse events were noted in all cases.
                Self-administration of vaginal misoprostol was successful in all women and 273 women were evaluated for main end-points. A significantly larger proportion of patients in the treatment group reached cervical dilatation of > or = 7 mm (67.3% v. 30.9%, P < 0.0001). The side-effects were minimal and comparable in the two groups. In the treatment group the mean procedure duration was significantly shorter (220 seconds v. 321 seconds, P = 0.0013) and the procedure was more likely to be rated by the operator as 'easy' (81.8% v. 63.3%, P = 0.0082). This resulted in a significant reduction in treatment failure in the < 70-day gestation group (5.0% v. 14.7%, P = 0.005).
                It is feasible, safe and effective for 600 micrograms misoprostol to be self-administered vaginally 2-4 hours pre-operatively for cervical priming prior to manual vacuum aspiration. Further research is needed to establish optimal use in the first trimester and to determine patient acceptance. To assess the clinical efficacy of pharmacologic, mechanical and combination techniques of cervical ripening.
                From March 1997 to August 1998, all cervical-ripening patients at Lehigh Valley Hospital were randomly assigned to three groups: intravaginal misoprostol, intracervical Foley catheter, or combination prostaglandin E2 (PGE2) gel and Foley catheter. Inclusion criteria included Bishop score < or = 5 and no contraindication to labor. The remaining delivery process was actively managed according to established guidelines. Multiple variables in perinatal outcome were analyzed, with the cesarean section rate and time from ripening to delivery as the main outcome variables.
                Of the 205 patients, 65 were randomized to the misoprostol group, 71 to the Foley group and 69 to the catheter-and-gel group. There were no differences between groups in delivery indications, maternal demographics, ultrasound findings, labor interventions, intrapartum times, mode of delivery, postpartum complications or neonatal outcomes. The misoprostol group demonstrated a higher rate of uterine tachysystole and required oxytocin less when compared to the two catheter groups.
                The higher rate of uterine tachysystole with misoprostol did not increase the cesarean section rate. The higher rate of oxytocin required by the two catheter groups did not increase the delivery time intervals. There appears to be no benefit to adding intracervical or intravaginal PGE2 gel to the intracervical Foley balloon. The misoprostol and catheter ripening techniques have similar safety and efficacy. The objective of this prospective randomized placebo-controlled study was to determine the efficacy of sublingual misoprostol in facilitating cervical dilatation before surgical abortion in first trimester pregnancy. Sixty healthy pregnant women between 6 and 11 weeks of gestation opting for voluntary medical termination of pregnancy at All India Institute of Medical Sciences hospital were included in this study. Women were randomized to two groups, the study group (n = 30) received 400 micro g of sublingual misoprostol and the control group (n = 30) received placebo, 2 h prior to surgical abortion. Using Hegar's dilators, cervical dilatation prior to vacuum aspiration was measured. Other parameters assessed included the total time required for the procedure, intraoperative blood loss and associated side effects. The mean cervical dilatation in the misoprostol group was 7.7 mm as compared to 3.4 mm for placebo group. The average time required for pregnancy termination was significantly shorter (p < 0.001) in the misoprostol group. The procedure-related blood loss was also significantly decreased in the misoprostol group. However, side effects including pre-evacuation vaginal bleeding, lower abdominal pain, nausea and vomiting were significantly higher in the misoprostol group than in placebo group (p < 0.005). There was no case of hemorrhage or uterine perforation in either group. Sublingual misoprostol is effective in facilitating cervical dilatation prior to surgical abortion. Its usage significantly decreased the time of surgical evacuation and minimized blood loss during the procedure. To determine if the addition of a mechanical ripening agent (transcervical Foley balloon) to a pharmacologic agent (intravaginal misoprostol) improves the efficiency of preinduction cervical ripening.
                Singleton patients with an indication for delivery, unfavorable cervix (Bishop score < or = 5) and no contraindication to labor were randomly assigned to two groups: misoprostol alone (25 micrograms intravaginally every 3 hours for no more than 12 hr) or combination therapy (25-French transcervical Foley balloon inflated to 50 mL of sterile water with identical intravaginal misoprostol dosing). All patients received a history and physical examination (including Bishop score), preripening ultrasound, electronic fetal heart rate and contraction monitoring (to rule out spontaneous labor and document fetal well-being). Multiple variables of perinatal outcome were analyzed, including the main outcome variables of ripening-to-delivery time and cesarean section rate.
                During August 1998 to August 1999, 81 patients were randomized, 40 to misoprostol alone and 41 to combination therapy. There were no differences between the groups with respect to maternal demographics, preripening Bishop score, maternal complications, intrapartum intervention or neonatal outcome. The misoprostol group spent longer periods of time in active labor, and there was a trend for the combination group to require oxytocin for longer intervals. These findings did not significantly affect the total ripening-to-delivery time or cesarean section rate which were similar for both groups.
                The addition of mechanical ripening with a transcervical Foley balloon to intravaginal misoprostol did not improve the efficiency of preinduction cervical ripening. Mechanical and pharmacologic cervical ripening agents appear to act independently rather than synergistically. Liberalization of the law in respect of legal abortions has led to a search for an appropriate technique for termination of pregnancy. The technique should be cheap, easy to perform and have minimal or no complications.
                To evaluate the effectiveness of performing manual vacuum aspiration (MVA) with and without the use of misoprostol to the procedure.
                Randomised control study.
                Obstetrics and Gynaecology Department, University of Natal Medical School, South Africa.
                One hundred and thirty six women were recruited; 70 women were assigned to the misoprostol group. Of these, 11 (15%) did not show any change in cervical score. Their mean cervical dilatation was similar to the control group (3.3 versus 31; p > 0.06). In the group whose gestational age was less than eight weeks, the time taken to complete the procedure, quantity of products of conception and cervical dilatation, were different from that of the control group, and this reached statistical significance except quantity of products of conception in primigravidae. In pregnancies greater than eight weeks gestation, all parameters assessed, such as cervical dilatation, quantity of products of conception was significantly different from the control group, in both multi- and primigravidae. Pain score was similar for all gestations.
                Misoprostol is of specific value during MVA for voluntary interruption of pregnancy. To compare the effectiveness of oral misoprostol with vaginal misoprostol as a cervical priming agent prior to first trimester vacuum aspiration.
                Randomised study.
                Scottish teaching hospital.
                Primigravid women at gestations up to 91 days requesting surgical abortion under the 1967 Abortion Act.
                Sixty-four women were randomised to receive misoprostol 400 microg orally at home or vaginally in hospital 2-4 hours pre-operatively for cervical priming.
                The main outcome measures were cumulative force required to dilate the cervix to 9 mm, baseline cervical dilatation, intra-operative blood loss and patient and staff acceptability.
                There was no significant difference in baseline cervical dilatation, peak force required to dilate the cervix at 8 and 9 mm and cumulative force required between the two groups. Operating time and intra-operative blood loss were not significantly different between the two groups. The priming to abortion interval was significantly longer with oral misoprostol when compared with the vaginal group (P < 0.0001). Women receiving oral misoprostol were significantly more likely to experience nausea (OR: 3.9, 95% CI: 1.3 to 11.2), while women receiving vaginal misoprostol were more likely to complain of tiredness (OR: 0.2, 95% CI: 0.1 to 0.7) with no significant differences in other side effects between the two groups. There was no significant difference in patient acceptability in relation to the priming agent between the two groups (P = 0.96). However, majority of the nursing staff (83%) admitting women preferred the oral route of administration.
                Cervical priming with oral misoprostol at home is effective with high patient and staff acceptability. To compare the efficacy of 400 microg of misoprostol with that of 1 mg of gemeprost as cervical priming agents when administered vaginally 3 to 4 hours before first-trimester vacuum aspiration abortion.
                In a prospective controlled trial 90 nulliparous women who requested termination of pregnancy before 12 weeks' gestation were randomized to receive vaginally either misoprostol or gemeprost for cervical priming. The force to dilate the cervix was measured by the use of a cervical tonometer connected to Hegar dilators from 3 to 10 mm. The main outcome measures were baseline cervical dilation; the peak force to dilate the cervix at 8, 9, and 10 mm; and the cumulative force to dilate the cervix to 10 mm.
                Baseline cervical dilation did not differ significantly between the women who received misoprostol and those who were treated with gemeprost. Neither the peak force required to dilate the cervix at 8, 9, and 10 mm nor the cumulative force to dilate the cervix to 10 mm showed any significant difference between the two groups.
                Vaginally administered misoprostol (400 microg) is as effective as gemeprost (1 mg) for cervical priming 3 to 4 hours before surgical termination of first-trimester pregnancies. To determine the optimal evacuation time interval in the use of vaginal misoprostol for cervical priming before first trimester termination of pregnancy.
                Prospective double-blind randomised study.
                Fertility Control Centre, National University Hospital, Singapore.
                Sixty healthy nulliparous women requesting legal termination of pregnancy between 6 and 11 weeks of gestation were randomly allocated to either the 400 microg or 600 microg misoprostol group. Vacuum aspiration was performed after three hours in the 400 microg group and at the end of two hours in the women given 600 microg misoprostol. Using Hegar's dilator, degree of cervical dilatation before operation was measured. Other parameters assessed included the amount of additional dilatation required (if < Hegar 8), pre-operative and intra-operative blood loss, and associated side effects.
                For the 600 microg group, only five women (16.7%) achieved a cervical dilatation of > or = 8 mm, compared with 28 women (93.3%) in the 400 microg group. Using the 400 microg misoprostol group as a baseline, the odds ratio was 0.014 (95% CI 0.003-0.080) for 600 microg for successful pre-operative cervical dilatation of > or = 8 mm. The mean cervical dilatation for 400 and 600 microg misoprostol was 8.1 mm and 6.6 mm, respectively (P < 0.001). Despite the shorter evacuation time interval of two hours, the 600 microg dose was associated with an increase in side effects such as vaginal bleeding, abdominal pain and a fever of > 38.0 degrees C. However, other than abdominal pain, no significant differences in the frequency of these side effects were shown.
                Use of 400 microg misoprostol with a minimal evacuation time interval of three hours still appears the optimal dosage and evacuation time for cervical priming before first trimester termination of pregnancy. To compare the efficacy and tolerability of sublingual misoprostol with those of intramuscular 15-methyl-prostaglandin F2alpha (15-M-PG F2alpha) for cervical dilation prior to vacuum aspiration (VA) in first-trimester pregnancy termination.
                Sixty pregnant women requesting pregnancy termination between the 9th and 12th week were randomized to receive 400 microg of sublingual misoprostol or an intramuscular injection of 125 microg of 15-M-PG F2alpha 2 h prior to vacuum aspiration. Baseline cervical dilation prior to vacuum aspiration was measured using Hegar's dilators. Other variables assessed included procedure duration, intraoperative blood loss, and associated adverse effects. Patient acceptability was assessed by questionnaires completed at the time of discharge from the hospital.
                Mean cervical dilation at vacuum aspiration was significantly greater in the misoprostol group than in the 15-M-PG F2alpha group (8.8 vs. 7.6 mm; P<0.01), and preoperative adverse effects were significantly less frequent in the sublingual misoprostol group (P<0.05). However, procedure duration and intraoperative blood loss were similar in both groups. The acceptability rates were 93.3% in the sublingual misoprostol group and 76.6% in the 15-M-PG F2alpha group, respectively; however, 6.6% patients in the sublingual misoprostol group thought that the tablets had an unpleasant taste.
                Sublingual misoprostol appears to be an effective alternative to intramuscular 15-M-PG F2alpha for cervical dilation prior to vacuum aspiration in first trimester pregnancy. In addition, misoprostol is inexpensive and convenient to use and has higher patient acceptability rates. To determine whether nitric oxide donors can induce cervical ripening before surgical termination of pregnancy in the first trimester.
                Prospective, randomised controlled trial.
                Department of Obstetrics and Gynaecology, Royal Infirmary, Glasgow.
                Forty-eight primigravid women undergoing surgical termination of pregnancy before 12 weeks of gestation.
                The women were randomised to receive per vaginam before surgery either the nitric oxide donor isosorbide mononitrate, the nitric oxide donor glyceryl trinitrate, the prostaglandin analogue gemeprost, or no treatment.
                The cumulative force required to dilate the cervix to 8 mm was measured objectively and the cervical diameter before surgical dilatation was recorded.
                Following isosorbide mononitrate or gemeprost, a lower cumulative force was required to dilate the cervix to 8 mm and a higher cervical diameter before dilatation was recorded. Pretreatment with glyceryl trinitrate reduced the cumulative force required to dilate the cervix but had no effect on cervical diameter.
                Like the prostaglandin analogue gemeprost, the nitric oxide donors isosorbide mononitrate and glyceryl trinitrate can effect cervical ripening. Nitric oxide donors may provide an alternative to prostaglandins for cervical ripening before surgical procedures in the first trimester. Our objective was to compare the sublingual administration and the vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion.
                We used an open, multicenter, randomized trial.
                We conducted the study in four clinics (in Valencia, Castelló, Murcia and Murcia Capital) in Spain.
                A total of 1424 healthy pregnant women with amenorrhea of <or=84 days who voluntarily decided to terminate their pregnancy participated in the study.
                Women were randomly assigned to receive a single dose of 400 microg of misoprostol either sublingually or vaginally 1-3 h before aspiration.
                The outcome measures assessed were cervical dilation before surgery and surgical time needed for aspiration. The incidence of side effects, such as nausea, vomiting, diarrhea, fever/chills and paresthesia, was evaluated.
                The mean cervical dilation achieved was 6.8+/-0.8 and 6.7+/-0.9 mm for the sublingual and vaginal groups, respectively. The mean surgical time was 7.0+/-2.8 and 7.4+/-2.5 min for the sublingual and vaginal groups, respectively. Nausea, vomiting and diarrhea were more frequent in the sublingual group.
                Both regimens had equal efficacy; however, the sublingual route caused more side effects. The objective of this study was to compare the oral and vaginal administration of misoprostol for cervical priming before surgical abortion up to 63 days' gestation. A total of 900 pregnant women, with ages ranging from 18 to 42 years, who asked for pregnancy termination, were included in this study. Women were randomly allocated to one of the following groups: oral administration of 400 microg misoprostol, 8 h before aspiration; and vaginal self-administration of 400 microg misoprostol, 4 h before aspiration. During admission, all subjects were checked on a 15-min basis. The preoperative cervical dilatation achieved was the main outcome assessed. The cervix was dilated (Hegar > or = 8) in 348 (78%) subjects from the oral treatment group and in 391 (87%) women from the vaginal treatment group; this difference was statistically significant (p = 0.0004). The mean dilatation achieved in the oral treatment group was 8.1 mm (SD 1.6 mm) and it was 8.5 mm (SD 1.5 mm) in the vaginal treatment group; this difference was statistically significant (p = 0.0001). The frequencies of side-effects such as nausea, vomiting, diarrhea and chills reported by women from the vaginal misoprostol group were 10, 8, 18 and 4 times lower, respectively, than those reported by subjects from the oral misoprostol group. In conclusion, vaginal self-administration of misoprostol was the best administration route, as it obtained the same or greater priming effectiveness of the cervix in half the time with a much lower frequency of side-effects. The objective of this prospective randomized placebo-controlled study was to determine the effectiveness of 400 mug oral and 400 mug vaginal misoprostol administration for cervical priming 3 h prior to manual vacuum aspiration (MVA) under local anesthesia for voluntary termination of pregnancy before 10 weeks of gestation in comparison with placebo oral or placebo vaginal administration (n=40 in each group). Postmedication cervical dilatation was similar in the oral (mean, 6.6+/-1.5) and vaginal (mean, 7.2+/-0.8) misoprostol groups but significantly higher compared with the oral (mean, 3.4+/-0.2) and vaginal (mean, 3.6+/-1.9) placebo groups. Duration of the procedure was also significantly shorter in the misoprostol groups in comparison with their placebo counterparts. Preoperative bleeding and side effects were more common in the misoprostol groups, but none required medical intervention. Intraoperative bleeding was less in the vaginal misoprostol group compared with the placebo groups. There was no significant difference in terms of visual analogue scores during the procedure, patient satisfaction, days of postoperative bleeding and rate of postoperative complications among the groups. Cervical priming with misoprostol administered orally or vaginally 3 h before MVA for termination of pregnancy under local anesthesia facilitates the procedure by decreasing the need for cervical dilatation and by shortening its duration without improving patients' pain perception and satisfaction mainly due to side effects. Misoprostol is an effective agent for pre-operative cervical priming before surgical termination of pregnancy in the first trimester. Previous studies have shown that both oral and vaginal routes are equally effective for such a purpose. This study aimed to compare a new route of sublingual administration to the vaginal route of administration for pre-operative cervical priming in first trimester surgical abortion.
                Eighty women with gestational age <12 weeks were randomized by a computer-generated model to receive 400 micro g of misoprostol either sublingually or vaginally 3 h prior to vacuum aspiration. The primary outcome measure was the degree of cervical dilatation, and secondary outcomes included the force required to dilate the cervix from 3 to 8 mm, intra-operative blood loss and incidence of pre-operative side-effects.
                There was no significant difference in the baseline cervical dilatation (sublingual: 7.6 +/- 1.3 mm; vaginal: 7.7 +/- 0.73 mm), cumulative force required to dilate the cervix from 3 to 8 mm (sublingual: 9.0 +/- 9.8 N; vaginal: 6.6 +/- 5.4 N) and total blood loss (sublingual: 52.1 +/- 20.2 ml; vaginal: 48.3 +/- 12.3 ml). Pre-operative side-effects were also similar.
                Both sublingual and vaginal misoprostol are effective in cervical priming before surgical termination of pregnancy in the first trimester. Sublingual misoprostol has the advantage of being more convenient to administer and may be more suitable for day surgery. This study was undertaken to compare the effectiveness of mifepristone orally administered at 24 or 48 hours before first-trimester vacuum aspiration abortion with that of vaginally administered misoprostol as a cervical priming agent.
                In a randomized comparative trial 90 women who requested surgical termination of pregnancy were randomly assigned to receive 200 mg mifepristone orally 24 or 48 hours before the operation or 800 microg misoprostol vaginally 2 to 4 hours before the operation. The main outcome measures were baseline cervical dilatation, cumulative force required to dilate the cervix to 9 mm, and intraoperative blood loss.
                The baseline cervical dilatation was significantly greater among women who received mifepristone 48 hours before the operation (P =.02). This group also required the least mechanical force to dilate the cervix (P =.06). There were no significant differences among the 3 groups in the intraoperative blood loss, in the operating time, or in patient acceptability. Side effects such as hot flushes and headaches were significantly higher among women who received mifepristone 24 or 48 hours before the operation than among those who received misoprostol (P =.01 and P =. 002, respectively).
                Mifepristone is an effective cervical priming agent when orally administered 48 hours before vacuum aspiration for termination of first-trimester pregnancy. Because of its cost and availability in comparison with misoprostol, however, selective use may have to be considered. To compare the impact of 200 and 400 microg oral misoprostol on pre-operative cervical priming in both primi- and multigravidae prior to first trimester termination of pregnancy. Pre-operative cervical dilatation and bleeding were assessed.
                Randomised controlled trial.
                Norwegian university teaching hospital.
                Five hundred and fifty-one women undergoing surgical termination of pregnancy between 7 and 12 weeks of gestation.
                Patients were randomised to either 200 or 400 microg of oral misoprostol 10-16 hours before vacuum aspiration. The degree of cervical dilatation prior to abortion by vacuum aspiration was measured. Pre-operative bleeding and pain were recorded and vaginal bleeding was measured.
                Degree of pre-operative cervical dilatation and pre-operative bleeding.
                The mean cervical dilatation was 5.8 mm (SD 1.7) for the women who received 400 microg misoprostol and 5.4 mm (SD 1.4) for those who received 200 microg (P= 0.004). The pre-operative dilatation was larger in multigravidae than in primigravidae in both dosage groups. The odds ratio (OR) of pre-operative bleeding was 3.3 (95% confidence interval [CI] 2.1-5.0) in the 400 microg dosage group, as compared with the group receiving 200 microg misoprostol. The occurrence of bleeding was dose-dependent. Frequency of bleeding was similar in multigravidae compared with primigravidae in the 400 microg dosage group, whereas the occurrence of bleeding was less in primigravidae than multigravidae in the 200 microg dosage group. Only 89 out of 551 patients bled one or more grams. The volumes measured were not statistically significantly different. Complications were minor, and were distributed equally between the two dosage groups.
                The 200 microg oral misoprostol compared with the 400 microg oral misoprostol given 10-16 hours before first trimester surgical abortions results in less pre-operative vaginal bleeding and in a statistically, although not clinically significant reduction in cervical dilatation. One hundred and nineteen women with singleton pregnancy and cephalic presentation requiring induction of labour in the presence of an unfavourable cervix (Bishop score < or = 4) were studied. Five patients were excluded because of failure to comply with the protocol. Cervical ripening was carried out using 3 different methods; 36 used the Atad Ripener Device, 39 received 0.5 mg PGE2 intracervical gel and 39 received at least one 3 mg PGE2 intravaginal pessary. There were no differences in the demographic characteristics and the indications for induction. Five patients developed complications during the ripening period necessitating intervention; 3 required emergency Caesarean section and 2 delivered vaginally. Although statistically there were no differences among the 3 methods of cervical ripening, the power of the study is probably not large enough to show the differences. The PGE2 pessary appears to be more effective with 68% of patients either going into labour during cervical ripening or succeeding in the cervical ripening compared to around 50% in the Atad and PGE2 gel groups. The vaginal delivery rate was 87.2% in the pessary group compared to 72.2% in the Atad group and 84.6% in the gel group. The duration of labour was also shorter in the pessary group with 73.5% delivered within 24 hours compared to 57.7% in the Atad group and 57.6% in the gel group. Although the results of the Atad device seem to be inferior, the risk of uterine hyperstimulation from the use of the device is probably lower than that of the PGE2 and may therefore be preferable in women with fetuses at high risk of fetal hypoxia. The study was conducted to assess the effectiveness of mifepristone 200 mg 48 h before administering misoprostol 600 mug, sublingual vs. vaginal route, prior to dilation and evacuation (D&E) in 12- to 20-week pregnancies.
                Randomized clinical trial.
                Clínica Mediterrania Médica, Valencia, Spain.
                Women with 12- to 20-week pregnancies wanting a voluntary abortion between July 9, 2004, and February 9, 2006.
                Nine hundred women were randomized to be included in one of the following four groups: (I) mifepristone 200 mg plus sublingual misoprostol 600 microg before D&E, (II) mifepristone 200 mg plus vaginal misoprostol 600 microg before D&E, (III) sublingual misoprostol 600 microg before D&E and (IV) vaginal misoprostol 600 microg before D&E.
                The degree of cervical dilation achieved before D&E, surgical time necessary to terminate the pregnancy and side effects of misoprostol.
                The average cervical dilation in the mifepristone groups was 12.5+/-2.8 mm (SD) [95% confidence interval (CI), 12.3-12.8] vs. 8.5+/-3.2 mm (SD) (95% CI, 8.2-8.8) in those receiving only misoprostol. Surgical time in the mifepristone sublingual misoprostol group was 11.9+/-4.3 min (SD) vs. 13.0+/-5.3 min (SD) in the sublingual misoprostol group without mifepristone (p=.007); in the mifepristone vaginal misoprostol group, the average surgical time was 12.3+/-5.0 min (SD) vs. 13.0+/-6.2 (SD) in the vaginal misoprostol group without mifepristone (p=.031).
                Administering mifepristone before D&E with misoprostol in second-trimester abortions makes surgery easier and shorter and, to a certain extent, lessens the risk of cervical injuries, especially in D&E in advanced gestational periods. Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester termination of pregnancy. Previous studies showed that the oral route was more acceptable to patients but there were higher incidences of side-effects when compared with the vaginal route. This study is to determine the optimal dosage and route of administration of misoprostol for pre-operative cervical dilatation. A double-blind, randomized trial was undertaken for 225 nulliparous women with 8-12 weeks amenorrhoea. They were randomly assigned to groups given 0 (placebo), 200 or 400 microg oral or vaginal misoprostol 3 h prior to vacuum aspiration. In misoprostol-treated groups the baseline cervical dilatation was significantly increased when compared with the placebo group; the effect was dose-related in the oral but not in the vaginal group. The cumulative force and blood loss was significantly decreased in the misoprostol-treated groups. The incidences of side-effects were more frequent in misoprostol groups but were not related to the route and dosage of medication. The duration of procedure, incidences of post-operative complications, the duration of post-operative bleeding and the interval to the first period were similar in the five treatment groups. We conclude that a 3 h pre-treatment interval is effective for both oral and vaginal routes. When given orally, 400 microg is more effective than 200 microg. The efficacy was otherwise similar when compared with the vaginal route. We recommend 400 microg oral misoprostol 3 h prior to vacuum aspiration for cervical dilatation. To compare the use of laminaria tents with misoprostol for cervical ripening prior to first trimester surgical abortion.
                In a prospective, open-label, randomized trial, 70 women were assigned to have either insertion of a 3 mm intracervical laminaria tent or vaginal misoprostol 200 microg on the day prior to suction dilatation and curettage (D and C). Cervical dilatation and operating time were measured at the time of D and C; the surgeon subjectively rated the ease of dilatation. The women were interviewed just prior to the D and C with regard to pain, vaginal bleeding, and dilator preference.
                Laminaria produced significantly (P < 0.001) greater pre-abortion dilatation of the cervix (34.8 Pratt +/- 6.2) than did misoprostol (28.4 Pratt +/- 5.8). There was no demonstrable difference in ease of dilatation or operating time. Women randomized to use of laminaria reported significantly more pain on insertion than did those who received misoprostol (P < 0.001). Conversely, misoprostol was associated with more vaginal bleeding (P < 0.01). Pain following insertion was similar in each group. Two patients aborted completely after misoprostol alone. Overall, the stated patient preference for cervical dilator was more likely to be misoprostol (P < 0.01).
                Laminaria tents are more effective cervical dilators than vaginal misoprostol when inserted the day prior to suction D and C. Vaginal misoprostol insertion is more comfortable, although it is associated with an increased risk of vaginal bleeding and may abort the pregnancy. Patient preference favours misoprostol. In patient-centred care, both laminaria and misoprostol are suitable options for cervical preparation prior to suction D and C. In the article are presented the results of a randomized double-blind study comparing the efficacy and tolerance of vaginal administration of 1.0 mg 16,16-dimethyl-trans-delta 2-PGE1 methyl ester and placebo as a pretreatment to vacuum aspiration for termination of pregnancy in nulliparae in the 8th to 12th weeks of gestation. One-hundred and-twenty-six patients fulfilled all the criteria for acceptance in the study and received either 1 mg of the E analogue or placebo three hours prior to vacuum aspiration. The mean cervical dilation at operation was following treatment with the E analogue 6.5 mm and with placebo 4.9 mm (p less than 0.001). The number of patients requiring no further mechanical dilation or the dilatation was considered easy was significantly higher in the prostaglandin-treated group than in the placebo group (p less than 0.001). The mean blood loss at operation was also higher in the placebo group (p less than 0.001). Uterine pain was slightly more common following prostaglandin treatment (p less than 0.05) while gastrointestinal side effects occurred equally often in both groups. In two patients the uterine wall was perforated, both perforations occurring in the placebo group. Late complication rates were comparable between the two groups. It can be concluded that pretreatment with the E analogue accomplishes sufficient dilatation and softening of the cervix in most patients. The efficacy of the procedure and its low frequency of side effects and complications make the procedure useful for cervical dilatation prior to vacuum aspiration in late first trimester pregnancy. This study was undertaken to determine whether buccal misoprostol improves cervical preparation achieved with laminaria before second-trimester dilation and evacuation procedures.
                A randomized, double blind, placebo-controlled trial of preoperative cervical preparation with overnight laminaria and either buccal placebo or 400 microg buccal misoprostol approximately 90 minutes before second-trimester surgical abortion. Block randomization was used to provide balanced enrollment into 2 separate gestational age study groups: early (13-15(6/7)) and mid (16-20(6/7)) second trimester. Surgeons tested maximal cervical dilation by inserting the largest dilator that could be passed through the cervical os without force. Subject demographics and preprocedure symptoms were tracked.
                Groups were similar in regard to age, gravity, parity, delivery type, and gestational age. Data were analyzed from 125 women in the 13 to 15(6/7) (30 misoprostol, 32 placebo) and 16 to 20(6/7) (31 misoprostol, 32 placebo) gestational age groups. Overall, misoprostol treatment did not improve the initial mean dilation achieved with laminaria alone in either the 13 to 15(6/7) (46.0 fr +/- 5.0; placebo 45.0 fr +/- 6.2, P = .68) or 16 to 20(6/7) (50.9 fr +/- 5.6, placebo 48.9 fr +/- 5.2, P = .16) groups. However, a subanalysis of gestations 19 weeks or more demonstrated significantly greater dilation in the misoprostol group (53.6 fr fr +/- 5.3, placebo 48.5 fr +/- 5.0, P = .01). Subjects receiving misoprostol reported significantly more cramping than those receiving placebo (13-15(6/7) weeks misoprostol 25/30, 83%; placebo 17/32, 53%, P = .02; 16-20(6/7) week misoprostol 25/31, 81%, placebo 16/32, 50%, P = .02).
                Cervical dilation with laminaria is augmented by 400 microg buccal misoprostol in gestations 19 weeks or more, but not in earlier gestations. Misoprostol causes more abdominal cramping. To compare intravaginal misoprostol to prostaglandin (PG) E2 for cervical ripening in women with premature rupture of the membranes (PROM) after 34 weeks of gestation.
                Women with PROM after 34 weeks of gestation and an unripe cervix were randomized to receive PGE2 (2.5 mg) or misoprostol (50 microg). Both agents were placed intravaginally immediately after randomization, and the dose was repeated 6 hours later if necessary. After another 6 hours from the second insertion, oxytocin treatment was started if labor had not begun. Forty patients in each group were required to show a 30% improvement in delivery within 12 hours in the misoprostol group.
                One hundred nine patients were randomized; 54 were assigned to misoprostol and 55 to PGE2. Important demographic and clinical characteristics were similar between the groups. The mean time from first insertion to delivery was 16.4 hours in the misoprostol group and 22.0 hours in the PGE2 group. A second dose was required less frequently in the misoprostol group (22% vs 62% in the PGE2 group), and the percentage of patients delivered within 12 hours was higher in the misoprostol group (41% vs 16%). Tachysystole occurred in 20% and 6% of women in the misoprostol and PGE2 groups, respectively. Hyperstimulation occurred in 9% and 0%, and cesarean delivery in 19% and 26% of women in the misoprostol and PGE2 groups, respectively. Neonatal outcome was similar between groups.
                Intravaginal misoprostol is more effective than local PGE2 application to treat PROM after 34 weeks of gestation, but tachysystole occurs more commonly with misoprostol. To compare the efficacy of a nitric oxide donor (isosorbide mononitrate) and a prostaglandin E1 analogue (misoprostol) for cervical priming before suction termination of pregnancy.
                This was a randomized, double blind, placebo-controlled trial. One hundred twenty-six healthy women requesting termination of pregnancy between 9 and 12 weeks' gestation were recruited. Women were randomized into three groups: control, isosorbide mononitrate, and misoprostol. All women were given moistened intravaginal study drugs (placebo, 40 mg of isosorbide mononitrate, or 400 microg of misoprostol) 4-6 hours before suction evacuation. Side effects were assessed 3 hours after drug administration. The cervical dilatation and the cumulative force required to dilate the cervix to 8 mm were measured by a cervical tonometer before suction evacuation. Operative blood loss was measured after sieving off the products of gestation.
                There were no differences in the baseline cervical dilatation, cumulative force, and operative blood loss between the isosorbide mononitrate and placebo groups. However, women in the misoprostol group had a significantly greater cervical dilatation, required less cumulative force, and had less blood loss than women in the isosorbide mononitrate or control group. The majority (more than 80%) of women in all three groups found their cervical priming agents acceptable.
                Intravaginal isosorbide mononitrate was less effective than misoprostol in cervical ripening before suction termination of pregnancy. The authors report the preliminary results of a randomised prospective study begun in April 1992 at the maternity unit of the Caen Regional Hospital group. The aim of the study was to compare the efficacy and tolerability of three methods of cervical ripening in patients at term in whom there was an indication for the induction of labour while local conditions were unfavourable (Bishop score less than 6). In the first group, patients received an intracervical instillation of prostaglandins E2 (Prepidil), in accordance with the usual method of the department. In the patients of the second group, an intracervical Foley catheter with its balloon inflated to 50 cc was inserted and left under traction for 12 hours. Management of patients in the third group consisted of an extraamniotic injection of prostaglandins E2 via a Foley catheter previously inserted into the cervix and the balloon of which was also inflated with 50 cc of sterile water and which was left in place for 12 hours. Regardless of the method, each patient could undergo 3 ripening procedures separated by 24 hour intervals, provided the Bishop score did not reach 6. These results, which concern the first 184 patients enrolled in the protocol show the superior efficacy of the catheter + Prepidil method as compared with the other two (75% success rate after ripening as compared with 50% in each of the other two groups) as well as that intracervical Prepidil is equally effective in terms of success/failure as an intracervical catheter alone.(ABSTRACT TRUNCATED AT 250 WORDS) The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction.
                Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 microg oral doses of misoprostol, or (3) serial 100-microg oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified.
                There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH.
                Oral 100 microg serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor. To evaluate the efficacy of intravaginal prostaglandin E1 methyl analogue misoprostol in cervical ripening in patients with unfavorable cervix (Bishop score < 4) requiring labor induction.
                A randomized controlled clinical trial of 62 women in the third trimester with various indications for induction of labor were randomly allocated to receive either 100 micrograms misoprostol inserted vaginally (32) or placebo similarly applied (30). Transvaginal sonography was performed to measure the cervical length before and 12 hrs after insertion.
                The mean change in cervical length and Bishop score was significantly greater in the misoprostol group (24 mm and score 8) compared with in the placebo group (2.2 mm and score 1) (p = 0.001). All but one patients receiving misoprostol went into labor while only one in the placebo group did so. The interval from insertion to vaginal delivery was significantly shorter in the misoprostol group (12.0 vs 25.5 hrs, p < 0.001). Delivery occurred within 24 hrs in 75% and 30% of patients in the misoprostol and placebo groups respectively. Uterine tachsystole occurred more frequently in the misoprostol group (38%) than in the placebo group (0%) (p < 0.001). All could be rapidly reversed by tocolytics without apparent untoward intrapartum effects. No significant differences were noted in the 2 groups in terms of perinatal outcomes and mode of delivery.
                Intravaginal misoprostol is an effective, cheap and safe method for cervical ripening. The higher frequency of uterine tachysystole in the misoprostol group did not increase the risk of adverse intrapartum and neonatal outcomes. The purpose of this study was to compare the effectiveness of the sublingual and vaginal administration of misoprostol for cervical priming before surgical termination of pregnancy.
                In a randomized controlled trial, 74 primigravid women who were undergoing surgical abortion were assigned randomly to receive misoprostol (400 microg) sublingually or vaginally.
                There was no statistically significant difference in the cumulative force that was required to dilate the cervix to 9 mm, for baseline cervical dilatation, for priming to abortion interval, for operating time, or for intraoperative blood loss between the two groups. Women in the sublingual group had more nausea (P=.008), vomiting (P=.01), diarrhea (P=.01), and unpleasant mouth taste (P=.0001) compared with the women in the vaginal group. In the sublingual group, 65% of women were satisfied with the route of misoprostol administration compared with 78% in the vaginal group (P=.11). Most of the staff members (84%) said that they would recommend the sublingual administration of misoprostol (P=.0001).
                The sublingual administration of misoprostol is an effective alternative to vaginal administration for cervical priming before surgical abortion; despite a higher incidence of side effects, there was high patient and staff acceptability. To compare the efficacy and acceptability of oral misoprostol, vaginal misoprostol, and laminaria tents for cervical dilation before surgical abortion.
                We conducted a randomized, double-blind, placebo-controlled trial comparing oral misoprostol 400 microg, vaginal misoprostol 400 microg, and one medium laminaria for dilating the cervix over 4 hours before surgical abortion. The study sample consisted of 106 women at 7-14 weeks' gestation who presented to San Francisco General Hospital requesting abortion. The primary outcome was the amount of cervical dilation measured by Pratt dilators. Secondary outcomes were the proportion of subjects needing further manual dilation, difficulty of dilation, duration of the procedure, blood loss, and side effects.
                The vaginal-misoprostol group had a significantly greater mean dilation (28.0 mm) than the oral misoprostol group (24.2 mm; P < .05) and a greater mean dilation than the laminaria group (25.9 mm), although this difference did not reach significance. Women who received laminaria reported significantly more pain at the time of placement (85.7% reported at least "a little" pain) compared with women who received misoprostol by either route (28.9% of oral-misoprostol and 34.0% of vaginal-misoprostol subjects reported "a little" pain; P < .01). The proportion of subjects who required further manual dilation, ease of dilation, duration of the procedure, and blood loss were not significantly different among the groups. There was no difference in side effects during the 4-hour waiting period among the three groups, and gastrointestinal side effects were rare in all groups.
                Vaginal misoprostol is superior to oral misoprostol and is an acceptable alternative to laminaria tents for cervical dilation before surgical abortion in pregnancies of 7-14 weeks' gestation. It is inexpensive and easy to administer, and achieves equal or greater dilation with less pain on insertion and no increase in side effects compared with laminaria. Mifepristone (RU 486; Roussel-Uclaf, Paris, France) is an antiprogesterone used for termination of very early pregnancy. The ripening effect of Mifepristone on the human pregnant cervix was studied in 42 healthy women from 7 to 11 weeks gestation. The women were randomly allocated to oral treatment of either 100 mg Mifepristone or placebo for 24 and 12 hours before vacuum aspiration. An objective method has been designed to measure the force necessary to step-wise dilate the cervix from 4 to 11 mm. Significant (p less than 0.05) changes in the stiffness of the cervix were demonstrated in patients treated with Mifepristone, reflecting ripeness. The treatment was simple and had no side effects. Prostaglandin E2 for local application has been widely used for preinduction cervical ripening in cases presenting with an unfavorable cervical state. The optimal way of administering prostaglandin E2, however, remains unclear. The aim of this study was to compare the effect of multiple application of 0.5 mg Minprostin intracervical Gel to the effect of 3 mg Minprostin vaginal tablets in priming the uterine cervix and inducing labor in an open, prospective, randomised study.
                PGE2 was applied up to three times a day for two days until ripening was obtained or labor induced. In case no progress took place amniotomy was performed and i.v. oxytocin stimulation one hour later if necessary. A total of 208 pregnant women, consecutively admitted for induction of delivery, with Bishop Scores 0-5, were included.
                Minprostin gel (group I) and Minprostin tablets (group II) were equally effective in ripening the cervix. Delivery within 48 hours was achieved in 59% and 63% respectively. The mean number of applications was 2.6 (s.d. 1.6) and 2.7 (s.d. 1.3) respectively. In case more than four doses were required no further effect was seen on delivery rates. Rates of cesarean section (performed in 15% and 18% respectively), labor induction (3%/1%), drop outs (14%/12%) and failed inductions (10%/5%) were comparable. Patients in group I had a significantly lower demand for analgesia. A significantly shorter induction-delivery interval in group II was seen in patients with preinduction Bishop scores 3-5 compared to patients with Bishop scores 0-2. Side effects were few. Both procedures appear safe.
                Cervical ripening and induction of delivery by local administration of prostaglandin E2 gel or vaginal tablets in cases presenting with an unfavorable cervical state is equally effective. To assess women's acceptability, the efficacy and side effects of sublingual versus vaginal administration of misoprostol in combination with mifepristone for medical abortion up to 13 weeks of gestation.
                Randomised controlled trial.
                Aberdeen Royal Infirmary.
                Women undergoing medical abortion under the terms of the 1967 Abortion Act.
                Mifepristone (200 mg) was given orally followed 36-48 hours later by misoprostol administration (sublingual: 600 microg; vaginal: 800 microg). A second dose of misoprostol 400 microg was given 3 hours later (sublingually or vaginally). Women between 9 and 13 weeks of gestation received a further (third) dose of misoprostol 400 microg (sublingually or vaginally), 3 hours later if abortion had not occurred.
                Women's acceptability, efficacy of the regimen and side effects experienced.
                A total of 340 women were recruited (171 sublingual and 169 vaginal). A total of 70% of women in the sublingual group expressed satisfaction with the route of misoprostol administration; 18% answered 'Don't know' while 12% were dissatisfied, compared with 68%, 28% and 4%, respectively, in the vaginal group (P= 0.02). There was no significant difference in the need for surgical evacuation for women in the sublingual (3/158, 1.9%) and vaginal groups (4/156, 2.6%) (P= 0.70). Women receiving misoprostol sublingually were more likely to experience diarrhoea (P < 0.01), shivering (P < 0.01) and unpleasant mouth taste (P < 0.01).
                Sublingual administration of misoprostol is an effective alternative to vaginal administration for medical abortion up to 13 weeks of gestation. The prevalence of prostaglandin-related side effects, however, was higher with this route of administration. To determine the therapeutic efficacy and safety of a nitric oxide (NO) isosorbide dinitrate donor to induce cervical ripening of women with missed abortions before surgical evacuation of the uterus.
                A prospective, randomised, double-blind controlled trial.
                Tertiary referral maternity teaching hospital. Population Sixty women with missed abortions and no cervical dilation.
                Women requesting surgical evacuation of the uterus were randomly selected to receive endocervical 80 mg/1.5 mL isosorbide dinitrate gel solution (n= 30) or 400 mug/1.5 mL misoprostol gel solution (n= 30) every 3 hours to a maximum of four doses or until reaching cervical ripening. Vital signs and symptoms were recorded at baseline and then every 3 hours until finishing therapy. Adverse events, such as headache, abdominal pain, pelvic pain, backache, nausea and vomiting, were evaluated.
                Probability of reaching cervical ripening >8 mm Hegar dilator; evaluated at 3, 6, 9 and 12 hours after application of isosorbide dinitrate or misoprostol.
                The probabilities of induction of cervical ripening by isosorbide dinitrate and misoprostol after four repeated doses at 3-hour intervals were significantly different (P<0.001). Efficacy of therapy after 12 hours was 97% for the isosorbide dinitrate group and 70% for the misoprostol group. Systolic and diastolic blood pressures were lower after administration of isosorbide dinitrate than prostaglandin analogues. The difference in the mean systolic and diastolic blood pressure between treatment groups was greatest at 3 hours, with a difference of 7.7 mmHg (P<0.001) and 5.9 mmHg (P<0.003), respectively. The most frequent side effect associated with isosorbide dinitrate administration was headache, which occurred in 18 out of 30 patients, compared with only 5 out of 30 women in the misoprostol group [relative risk (RR) 2.41, 95% confidence interval (CI) 1.45-4.03, P<0.001). Women treated with misoprostol reported mainly pelvic pain (RR 3.24, 95% CI 1.99-5.27, P<0.001).
                Intracervical administration of 80 mg isosorbide dinitrate in women with missed abortions appears to be effective for cervical ripening prior to surgical evacuation of the uterus. Differences in the incidence of non-serious adverse events are not likely to be clinically significant. The object of this study was to compare intravaginal misoprostol and dinoprostone (prostaglandin E2) for second-trimester pregnancy termination, and to examine the role of the nitric oxide donor, glyceryl trinitrate, as a possible alternative to prostaglandins to induce cervical ripening in second-trimester pregnancy termination. This was a randomised clinical trial. The trial involved pregnant women between 13 and 28 weeks' gestation admitted with clear medical or obstetric indications for pregnancy termination, and was carried out in the department of obstetrics and gynecology, Assiut University Hospital, Egypt. Patients were classified into Group A, where pregnancy termination was induced by vaginal misoprostol 100 micrograms every 4 hours with a maximum dose of 500 micrograms; Group B, where induction was by vaginal dinoprostone 6 mg every 6 hours with a maximum dose of 24 mg; and Group C, where induction involved vaginal glyceryl trinitrate 500 micrograms every 6 hours with a maximum dose of 2.5 mg. Twenty-four hours after the start of induction, the rate of complete abortion in the three groups was 100%, 66.67% and 0%, respectively. The rate of complete abortion was 100% in the nitric oxide (glyceryl trinitrate)-induced group after introducing a complementary procedure. The induction-abortion interval was significantly shorter, the number of doses needed was less and the maximum Bishop score reached was greater with misoprostol than with dinoprostone. A higher rate of side effects occurred with the misoprostol-induced group (74%) compared with the other two groups (46.6% and 0%). Misoprostol is a cheap, effective drug for second-trimester pregnancy termination with short induction abortion intervals but a higher rate of side effects. Prostin E2 is also effective in termination of second-trimester pregnancy but is expensive and may require high doses to be administered. Glyceryl trinitrate is an effective drug for cervical ripening (softening) but it has no role in the stimulation of uterine contractions. The effectiveness of oral misoprostol versus vaginal gemeprost for cervical dilatation prior to vacuum aspiration was compared in women in the 6th to 12th week of pregnancy. Sixty-four nulliparous women requesting termination of pregnancy between 6th to 12th weeks of gestation were randomized to receive either 400 micrograms misoprostol orally or 1 mg vaginal gemeprost at 12 hr or 3 hr prior to vacuum aspiration, respectively. The cervical dilatation at vacuum aspiration, the ease of the subsequent surgical procedure, and the incidence of complications and side effects were compared between these two methods of cervical priming. The median cervical dilatation at vacuum aspiration in the misoprostol group was significantly greater than that in the gemeprost group (8.0 mm versus 7.0 mm, p < 0.02). Preoperative side effects were significantly less frequent in the misoprostol group (p < 0.01). The ease of dilatation assessed subjectively by the operating surgeons was also improved significantly in the misoprostol group (p < 0.01). However, the duration of operation and blood loss were similar in both groups. Since misoprostol is also much cheaper and more convenient to use, we conclude that oral misoprostol is better than vaginal gemeprost for cervical dilatation prior to vacuum aspiration in first trimester pregnancy. To compare the impact of 400 mug oral versus self-administered vaginal misoprostol at home on pre-operative cervical priming in both primigravid and multigravid women prior to first trimester surgical abortion.
                Randomised controlled trial.
                Norwegian University Teaching Hospital.
                Three hundred and thirty-eight women undergoing surgical abortion between 7 and 12 weeks of gestation.
                The women were randomised to either 400 microg of oral misoprostol the evening before or 400-microg of self-administered vaginal misoprostol at home the same day as vacuum aspiration. Main outcome measures Pre-operative cervical dilatation, complications and acceptability.
                The median cervical dilatation was 6.2 mm (range 0-11 mm) for the women in the 400 mug oral misoprostol and 6.5 mm (range 0-11 mm) in the 400-microg vaginal misoprostol groups. The median pre-operative dilatation was larger in multigravidae (6.4 and 6.7 mm for the oral and vaginal routes, respectively) than in primigravidae (5.8 and 6.0 mm, respectively). In primigravidae, 19% achieved a pre-operative dilatation of > or = 7 mm, with no significant difference between oral and vaginal dosage. In multigravidae, 52% achieved a pre-operative dilatation of > or = 7 mm with vaginal dosage, compared with 36% with oral dosage (P = 0.03). There was no difference between non-immigrant versus immigrant women in pre-operative cervical dilatation. The 400-microg oral dosage group had a higher risk of bleeding, compared with the group receiving 400-microg vaginal misoprostol [odds ratio (OR) = 10.4; confidence interval (CI) 5.2-20.8]. There was no difference between non-immigrant and immigrant women in acceptability of self-administered vaginal misoprostol; almost all women found this administration route acceptable. Complications were minor and were distributed equally between the two dosage groups.
                The vaginal route will result in a satisfactory dilatation in about half of multigravidae but is much less effective in primigravidae. The oral route does not lead to satisfactory dilatation in either group and is associated with a higher occurrence of pre-operative bleeding. Self-administered vaginal misoprostol at home is highly acceptable. The objective of this study was to compare the efficacy and safety of two dosing regimens of misoprostol for cervical ripening and labor induction.
                Patients who fulfilled the study criteria were randomized to received misoprostol 25 microg or 50 microg intravaginally every 3 h for a total of eight doses for cervical ripening or until labor was established. Endpoints for successful cervical ripening was achievement of Bishop score of nine or greater, and for labor induction reaching the active phase of labor in the first 24 h. The rates of success, duration of first and second stages of labor, type of delivery, significant side effects, and neonatal outcome were measured and compared between the two study groups. Two hundred and fifty-one patients were randomized in two groups--126 received 50 microg and 125 received 25 microg misoprostol. Demographics of the two study groups were similar.
                Patients in the 50 microg group had a shorter first stage (848 min vs. 1,122 min, P < 0.007), shorter induction-to-vaginal delivery interval (933 min vs. 1,194 min, P < 0.013), decreased incidence of oxytocin augmentation (53.9% vs. 68%, P < 0.015), and decreased total units of oxytocin (2,763 mU vs. 5,236 mU, P < 0.023), but there was a higher hyperstimulation rate (19% vs. 7.2%, P < 0.005).
                Successful induction rate, delivery types, and fetal outcome were similar in both groups. Although the rate of vaginal delivery and neonatal outcome were similar in both groups, the 50 microg regimen had shorter first and second stages of labor, and a higher hyperstimulation rate that was easily manageable, allowing for flexibility in using the higher dose in low-risk pregnancies. Intravaginal misoprostol has been shown to be effective for cervical priming before a surgically induced abortion. The objective was to investigate the effectiveness of oral misoprostol in cervical dilatation prior to vacuum aspiration between the 6th and 12th weeks of pregnancy. The results showed that in nulliparous patients, the median cervical dilatation in the treatment group (7.8 mm) was significantly greater than that in the placebo group (3.7 mm). In multiparous patients, the difference was also statistically significant (9.8 versus 6.0 mm). The ease of dilatation, assessed subjectively by the operating surgeons, was significantly improved in the treatment group. There was also a significant reduction in the duration of the operation and in the mean blood loss in the treatment group. The side-effects encountered in the treatment group were mild and well accepted by the women. Oral misoprostol is an effective and safe method for cervical dilatation prior to vacuum aspiration in first trimester pregnancy. Our purpose was to compare the effectiveness, women's views of the termination procedure, and success of umbilical cord culture for vaginal and oral misoprostol versus intra-amniotic prostaglandin PGF(2alpha) for second-trimester pregnancy termination (STPT).
                We randomized 217 women, 15 to 24 weeks' gestation, into 3 groups. Oral (OM) and vaginal (VM) misoprostol groups received 400 microg of misoprostol every 4 hours for 24 hours. The intra-amniotic PGF(2alpha) (IAPG) group received 40 mg of PGF(2alpha) followed by oxytocin infusion. Women completed self-administered questionnaires 3 weeks after the termination procedure. Umbilical cord samples were collected at delivery for karyotype analysis. The primary outcome was the time from start of the procedure to placental delivery. Secondary outcomes were maternal complications, women's acceptance of the termination procedure, and success rates of umbilical cord culture.
                The time was longer for the OM group (30.5+/-14.4 hours) compared with the VM group (18.3+/-8.2 hours) and the IAPG group (21.1+/-10.2 hours), P<.001 for both comparisons. Women in the VM group reported being more willing to repeat the termination method in the future and reported fewer side effects than those in the other groups, P<.001. Failure rates for umbilical cord cultures were 9.6%, 17.0%, and 45.6% for the VM, OM, and IAPG groups, respectively.
                Oral misoprostol is less effective than intra-amniotic PGF(2alpha) or vaginal misoprostol for STPT. Women report vaginal misoprostol more acceptable than other methods. Umbilical cord culture failure rate is highest in the IAPG group. Although it is well established that cervical priming before surgically induced abortion reduces the incidence of complications, its use is infrequent and confined to groups perceived to be at high risk. We compared the effect of prostaglandin E1 analogues, gemeprost and misoprostol, on the cervix. Both induced clinical and histochemical changes that were significantly different from controls and were likely to have therapeutic value. Misoprostol, however, is cheap, easily stored, and associated with few side-effects. Cervical pre-dilation with misoprostol may be considered in all women having surgically induced abortions. The purpose of this study was to compare the effectiveness and safety of vaginally administered 5 mg prostaglandin E2 gel prepared in our hospital pharmacy with a commercially available 0.5 mg intracervical prostaglandin E2 gel.
                Eighty-three patients undergoing labor induction were randomly assigned to one of two groups for cervical ripening. Either a preparation of 5 mg of prostaglandin E2 was placed vaginally or a commercially available 0.5 mg of prostaglandin E2 was placed intracervically. A maximum of three doses at 6-hour intervals was administered before oxytocin was begun.
                Among the 83 patients evaluated, 44 were given vaginal gel and 39 were given intracervical gel. No statistically significant differences were observed between the two treatment groups with respect to the incidence of spontaneous versus induced labor, need for oxytocin augmentation, gel-to-induction interval, Bishop score change, maximum oxytocin dose, maximum dilatation rate, length of labor, cesarean section rate, fetal Apgar scores, fetal umbilical vein pH, or fetal umbilical artery pH.
                The two prostaglandin E2 formulations appear equivalent in efficacy and safety. Constraints placed on intracervical prostaglandin E2 gel make the vaginal preparation a desirable choice. To determine if outpatient cervical ripening using misoprostol can initiate labor within 48 hours of medication administration and to determine if time from medication administration to time of delivery is decreased using outpatient cervical ripening.
                Uncomplicated singleton, vertex pregnancies at 41 weeks' gestation or later with Bishop score of 4 or less were eligible for enrollment. Other inclusion criteria included intact membranes, less than eight uterine contractions per hour, a reactive nonstress test, and amniotic fluid index (AFI) over 5 cm. After randomization, 25 micro(cg) of misoprostol or placebo was placed within the posterior vaginal fornix. Patients were continuously monitored for 4 hours, then discharged if not in active labor. Patients returned in 24 hours for a repeat administration of the respective medication. Patients not delivered within 48 hours were admitted for inpatient induction of labor. Statistical analysis was performed with the Fisher, Student t, chi(2), and Mann-Whitney U tests, with P <.05 considered statistically significant.
                Among the 60 patients enrolled, 27 (45%) received misoprostol and 33 (55%) received placebo. The majority (24 of 27, 88.9%) of study group patients entered active labor within 48 hours after dosing, compared with 16.7% (five of 33) of placebo group patients (P <.001). The time from initial dose to delivery was significantly shorter in the misoprostol group (36.9 +/- 3.8 compared with 61.3 +/- 3.8 hours, P <.001).
                Intravaginal misoprostol is effective for outpatient cervical ripening. No adverse effects were encountered, although further study is required to determine the safety of this treatment regimen. 66 primigravid women were allocated at random to receive either intravaginal application of the prostaglandin El analogue, gemeprost, or intracervical insertion of 1 of 2 osmotic dilators, Lamicel or Dilapan, 3 hours before legal abortion at 7-14 weeks gestation. Insertion of the dilators was not possible in 5 patients. All 3 methods were otherwise equally effective in achieving cervical dilatation and there was no difference in the need for or resistance to further dilatation between the 3 groups. Gemeprost was the most easily administered, and would be the most appropriate for routine preoperative use.
Modern methods of cervical ripening are generally safe, although efficacy and side-effects between methods vary. Reports of adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical preparation impacts these rare outcomes. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. These data do not suggest a gestational age where the benefits of cervical dilation outweigh the side-effects, including pain, that women experience with cervical ripening procedures or the prolongation of the time interval before procedure completion. Mifepristone 200 mg, osmotic dilators and misoprostol, 400µg administered either vaginally or sublingually, are the most effective methods of cervical preparation.