Management of miscarriage: a randomized controlled trial of expectant management versus surgical evacuation. Randomized outpatient clinical trial of medical evacuation and surgical curettage in incomplete miscarriage. Medical vs. surgical evacuation of first-trimester spontaneous abortion. Randomised trial comparing expectant with medical management for first trimester miscarriages. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management: a randomized trial. A randomised trial of surgical, medical and expectant management of first trimester spontaneous miscarriage. A randomized study comparing efficacy and patient satisfaction in medical or surgical treatment of miscarriage. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. A randomized comparison of sublingual and vaginal misoprostol for cervical priming before suction termination of first-trimester pregnancy. Randomised controlled trial comparing the efficacy of same-day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36 to 48 hour protocol. Second-trimester uterine evacuation: A comparison of intra-amniotic (15S)-15-methyl-prostaglandin F2alpha and intravaginal misoprostol. A randomized controlled trial of 400-μg sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Incomplete miscarriage: a randomized controlled trial comparing oral with vaginal misoprostol for medical evacuation. Two routes of administration for misoprostol in the treatment of incomplete abortion: a randomized clinical trial. Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Comparison of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion.
In many countries, surgical uterine evacuation is the standard treatment for women with a miscarriage, but expectant management has been advocated as an alternative. The choice between the two options cannot be based on published evidence alone, because randomized clinical trials are scarce while generalizability of findings to patients with a strong preference for either management options is unclear.
                In a randomized controlled trial, the complications and efficacy of either expectant or surgical management for miscarriages were compared, and the results in patients who refused randomization and were managed according to their own preference were studied. In total, 122 patients were randomized and 305 were managed according to their choice.
                No differences were found in the number of emergency curettages and complications between expectant and surgical management. Efficacy at 6 weeks was 30/64 (47%) in women allocated to expectant management, and 55/58 (95%) in women allocated to surgical evacuation. After 7 days, 37% of expectantly managed women had a spontaneous complete miscarriage. After 6 weeks, intention-to-treat analysis including cross-overs showed similar effectiveness (92% versus 100%). Results in the preference groups were comparable with those in the randomized groups.
                In our experience a waiting period of 7 days after diagnosis may prevent 37% of surgical procedures. To compare the efficacy and safety of misoprostol in outpatient medical evacuation with surgical curettage in uncomplicated incomplete spontaneous miscarriage.
                Eighty women with a history of vaginal bleeding, and passage of some products of the conceptus were randomized into two groups. Forty patients in Group 1 received 200 microg misoprostol q.i.d. after the application of 200 microg intravaginal misoprostol for 5 days; 40 patients in Group 2 had a surgical curettage performed. All of the patients were re-evaluated after 10 days. The success rates, mean number of days of bleeding, mean decreases in hemoglobin levels, the complications and the rates of patient dissatisfaction in the two groups were compared.
                The success rate in the misoprostol-administered group was 95% [corrected]. Although the mean number of days of bleeding was significantly higher in the misoprostol-administered group, the mean decreases in hemoglobin values in the two groups were not significantly different. The patient dissatisfaction rate was 2.5% in the misoprostol group, compared to 35% in the control group. The difference between the two groups was significant.
                The use of misoprostol in the outpatient treatment of uncomplicated incomplete spontaneous miscarriage is safe and effective and can be an alternative to surgical evacuation and expectant management. To determine whether management of incomplete first-trimester abortion with vaginal misoprostol in an under-resourced setting is a viable treatment option.
                A total of 94 women were randomized to 600 microg of misoprostol intravaginally or to surgical curettage. The women receiving misoprostol were administered a second dose if the abortion was incomplete; and if still not complete after a week, evacuation of retained products of conception was performed. All women had a follow-up visit 2 weeks following complete abortion.
                The overall success rate of medical management was 91.5%, with 15 of 47 successful cases after 1 dose of misoprostol; 8.5% of the 47 women required evacuation of retained products of conception after 1 week because of treatment failure. The success rate in the surgical arm was 100%. Patients in the medical arm had a longer duration of bleeding and a greater need for analgesia. There were no differences in hemoglobin levels, white blood cell count, adverse effects, pain score, and satisfaction with treatment at the follow-up visit. However, more women who received the medical treatment would recommend it or choose it in the future.
                Medical management using 600 microg of misoprostol in 2 doses is effective to treat incomplete first-trimester abortions in an under-resourced setting when there is no evidence of uterine sepsis. To compare the efficacy of antiprogesterone (mifepristone) in combination with a synthetic prostaglandin E1 analogue (misoprostol) for outpatient treatment of miscarriages.
                One hundred and twenty-two women with first trimester miscarriages.
                The women were randomised to treatment with mifepristone 400 mg orally followed by a single oral dose of 400 microg misoprostol 48 hours later (n = 60) or expectant management (n = 62). Women were re-evaluated five days later. If retained intrauterine products of conception were found with an antero-posterior diameter above 15 mm on transvaginal ultrasound, surgical evacuation was performed.
                Eighty-two percent of the women randomised to pharmacological treatment and 76% of those randomised to expectant management had an empty uterine cavity after five days. Convalescence time was 1.8 days longer for women randomised to pharmacological treatment. Pain, bleeding, complications, and satisfaction with the treatment did not differ between the groups.
                Most cases of spontaneous incomplete miscarriage will become a complete miscarriage without intervention. This study shows that outpatient treatment with a combination of antiprogesterone and a prostaglandin E1 analogue did not increase the rate of complete miscarriage, compared with expectancy alone, by a clinical important degree. Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject.
                Women with early pregnancy failure, who had been managed expectantly for at least 1 week, were assigned randomly (using a computer-generated list) to receive either vaginal misoprostol 800 microg or curettage. If, after 24 h, there had not been complete evacuation, a further 800 microg of misoprostol was administered. In the absence of complete evacuation after > days, curettage was performed. The primary end-point was the complete evacuation of the products of conception, with secondary end-points being the occurrence of side effects, pain intensity, need for analgesics, and intensity and duration of bleeding.
                In the misoprostol group, 47% (37/79) required curettage due to incomplete evacuation. After 1 week, evacuation was complete in 85% (67 out of 79) of the misoprostol group and 93% (70 out of 75) of the curettage group. Severity of pain, bleeding and emergency evacuation was higher in the misoprostol group. The complication rate was 0% for misoprostol and 4% for curettage.
                Curettage is superior to misoprostol in the evacuation of early pregnancy failure after failed expectant management. However, misoprostol could be clinically useful since it reduces the need for curettage by half and has a lower complication rate, at the expense of increased pain, vaginal bleeding and emergency evacuation.
                Copyright 2004 European Society of Human Reproduction and Embryology Medical management and expectant care have been considered possible alternatives to surgical evacuation of the uterus for first trimester spontaneous miscarriage in recent years.
                To compare the effectiveness and safety of medical and expectant management with surgical management for first trimester incomplete or inevitable miscarriage.
                Forty women were recruited following diagnosis of incomplete or inevitable miscarriage, and randomised to surgical, medical or expectant care via an off-site, computerised enrollment system. The primary outcome was the effectiveness of medical (vaginal misoprostol) and expectant management relative to surgical evacuation, assessed at 10-14 days and 8 weeks post-recruitment. Infection, pain, bleeding, anxiety, depression, physical and emotional recovery were assessed also. Analysis was by intention-to-treat.
                Effectiveness at 8 weeks was lower for medical (80.0%) and expectant (78.6%) than for surgical management (100.0%). Two women in the medical group had confirmed infections. Bleeding lasted longer in the expectant group than in the surgical group. There were no significant differences in pain, physical recovery, anxiety or depression between the groups. 54.6%, 42.9% and 57.1% of the surgical, medical and expectant groups respectively would opt for the same treatment again.
                Expectant care appears to be sufficiently safe and effective to be offered as an option for women. Medical management might carry a higher risk of infection than surgical or expectant care. To compare the efficacy of the medical treatment to surgical uterine evacuation and patient satisfaction in each group.
                A randomized, controlled study.
                An outpatient clinic in the Department of Gynecology and Obstetrics in Oulu University Hospital, Oulu, Finland.
                Ninety-eight eligible women who had had miscarriages.
                Medical treatment of miscarriage (n = 49) with 200 mg of mifepristone and 0.8 mg of misoprostol 1-3 days after the event or surgical uterine evacuation (n = 49). Questionnaires to collect data of experienced pain and patient satisfaction.
                The complete abortion rate with the primary treatment (primary outcome) and the patient satisfaction (secondary outcome).
                The success rate was equal (100% in surgical and 90% in medical group). More infections were diagnosed in the surgical group. Surgically treated patients were more satisfied with the treatment (100% vs. 88%). Medical treatment was considered more painful and fewer patients (70% vs. 91%) would choose the medical method in the future.
                Medical treatment is an effective alternative to surgical treatment and increases the choice available to women. Surgical treatment is associated with more infections. More medically treated patients experienced pain and dissatisfaction. Misoprostol is increasingly used to treat women who have a failed pregnancy in the first trimester. We assessed the efficacy, safety, and acceptability of this treatment in a large, randomized trial.
                A total of 652 women with a first-trimester pregnancy failure (anembryonic gestation, embryonic or fetal death, or incomplete or inevitable spontaneous abortion) were randomly assigned to receive 800 microg of misoprostol vaginally or to undergo vacuum aspiration (standard of care) in a 3:1 ratio. The misoprostol group received treatment on day 1, a second dose on day 3 if expulsion was incomplete, and vacuum aspiration on day 8 if expulsion was still incomplete. Surgical treatment (for the misoprostol group) or repeated aspiration (for the vacuum-aspiration group) within 30 days after the initial treatment constituted treatment failure.
                Of the 491 women assigned to receive misoprostol, 71 percent had complete expulsion by day 3 and 84 percent by day 8 (95 percent confidence interval, 81 to 87 percent). Treatment failed in 16 percent of the misoprostol group and 3 percent of the surgical group (absolute difference, 12 percent; 95 percent confidence interval, 9 to 16 percent) by day 30. Hemorrhage or endometritis requiring hospitalization was rare (1 percent or less in each group), with no significant differences between the groups. In the misoprostol group, 78 percent of the women stated that they would use misoprostol again if the need arose and 83 percent stated that they would recommend it to others.
                Treatment of early pregnancy failure with 800 microg of misoprostol vaginally is a safe and acceptable approach, with a success rate of approximately 84 percent.
                Copyright 2005 Massachusetts Medical Society. We aimed to determine whether outpatient treatment of miscarriage with vaginal misoprostol is more effective than expectant management in reducing the need for surgical evacuation of retained products of conception (ERPC).
                Of 131 eligible women with first trimester miscarriage, 104 agreed to randomization to either 600 microg misoprostol or placebo intravaginally. They were assessed the following day and administered a second dose of their allocated treatment if miscarriage was not complete. Those not successful after two doses were seen on day 7, and, if miscarriage was not complete, an ERPC was performed.
                The success rate of medical management was 88.5% (46/52) compared with 44.2% (23/52) for expectant management. There was no significant difference in success rate (100 versus 85.7%) in women treated with an incomplete miscarriage. Women with early pregnancy failure had a success rate of 87% with misoprostol compared with 29% with expectant management [odds ratio (OR) 15.96; 95% confidence interval (CI) 5.26, 48.37]. The complete miscarriage rate was achieved quicker in the medical group than the expectant group by day 1 (32.7 versus 5.8%) and by day 2 (73.1 versus 13.5%) of treatment. There were no differences in side-effects, bleeding duration, analgesia use, pain score and satisfaction with treatment. Women in the expectant group made more outpatient visits (5.06 versus 4.44%; OR = -0.62, 95% CI -1.04, -0.19). More women in the medical group (90.4 versus 73.1%; OR 1.26, 95% CI 1.05, 1.50) would elect the same treatment in the future.
                Medical management using 600 microg misoprostol vaginally is more effective than expectant management of early pregnancy failure. Misoprostol did not increase the side-effect profile and patient acceptability was superior to expectant management. 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. To determine the efficacy of oral mifepristone followed by vaginal misoprostol 6 hours later compared with the standard 36- to 48-hour regimen for medical termination of pregnancy.
                Single centre, two arm, parallel, open randomised controlled trial.
                Medical termination service at a teaching hospital.
                Four hundred and fifty women undergoing medical termination of pregnancy at up to 63 days of gestation.
                Eligible women were randomised to receive mifepristone 200 mg orally followed by vaginal misoprostol 800 micrograms either 6 hours (n=225) or 36-48 hours (n=225) later. All participants were invited to attend for a follow-up pelvic ultrasound scan within 7 days following the misoprostol administration. For those women in whom products of conception remained at the follow-up ultrasound scan, expectant management ensued with weekly follow-up ultrasound scans until the termination was complete. They could elect to undergo an evacuation of uterus at any stage following the scan. Those women with a nonviable gestation sac at the follow-up scan were offered a further dose of vaginal misoprostol 800 micrograms or suction termination of pregnancy. Women with a continuing pregnancy were managed with surgical termination.
                Successful medical abortion defined as no requirement for medical or surgical intervention beyond the initial dose of misoprostol.
                One hundred and sixty-five women (79%) in the 6-hour group and 197 women (92%) in the 36- to 48-hour group had a successful termination at first follow-up ultrasound or presumed on the basis of other considerations (those not seen for ultrasound but deemed successful by negative pregnancy test, products passed on ward or long-term assessment of notes). Twenty-two women (10%) in the 6-hour regimen required up to three further ultrasound scans after 7 days following the mifepristone administration in order to ensure that the termination process was complete. None of these women required a suction evacuation of uterus. In the 36- to 48-hour regimen, ten (5%) women had up to two further ultrasound scans to confirm a complete termination without the need for a surgical evacuation of uterus. Therefore, the overall successful termination rate in the 6-hour regimen was 89% (187/210) compared with 96% (207/215) in the 36- to 48-hour regimen (relative risk=0.92, 95% CI 0.84-0.98). Repeat administration of misoprostol or surgical treatment was required in 23 women (11%) in the 6-hour group and 8 women (4%) in the 36- to 48-hour group. A viable pregnancy was found in five women (2%) in the 6-hour group and in three women (1%) in the 36- to 48-hour group.
                Oral mifepristone 200 mg followed by vaginal misoprostol 800 micrograms after 6 hours is not as effective at achieving a complete abortion compared with the 36- to 48-hour protocol. Our purpose was to compare the efficacy, safety, and adverse effects of intra-amniotically administered (15S)-15-methyl-prostaglandin F(2alpha) and intravaginally administered misoprostol for second-trimester uterine evacuation.
                Fifty-one patients were randomly assigned to receive either a single 2.5-mg intra-amniotic injection of (15S)-15-methyl-prostaglandin F(2)(alpha) (n = 26) or two 200-microg intravaginal doses of misoprostol (n = 25) at 12-hour intervals. The primary outcome measured was evacuation of the uterus within 24 hours.
                The mean time from initiation of termination to uterine evacuation was less in the prostaglandin group than in the misoprostol group (17.5 +/- 8.6 hours vs 22.3 +/- 12.5 hours), but this was not statistically significant (P >.05). The rate of successful fetal evacuation at 24 hours was significantly higher in the prostaglandin group than in the misoprostol group (88% vs 60%, P =.02). The complete-abortion rate and the incidence of adverse effects were similar in both groups.
                The use of an intra-amniotic injection of (15S)-15-methyl-prostaglandin F(2alpha) for midtrimester pregnancy termination is safe and is associated with a greater number of successful uterine evacuations within 24 hours, without an increase in adverse effects, than intravaginal administration of misoprostol. To compare the safety, efficacy, and acceptability of 400-μg sublingual misoprostol with that of manual vacuum aspiration (MVA) in 2 Egyptian hospitals.
                Participating women were randomized to either MVA or misoprostol treatment for incomplete abortion. The primary outcome, complete uterine evacuation, was determined 1 week later, as were adverse effects, change in hemoglobin, acceptability, and satisfaction.
                Complete uterine evacuation was achieved in 98.3% of women who received misoprostol and 99.7% who underwent MVA (relative risk [RR] 0.99; 95% confidence interval [CI], 0.97-1.00). A decrease in hemoglobin of 2g/dL or more was comparably rare in the 2 groups (0.3% misoprostol vs 0.9% MVA; RR 0.34 [95% CI, 0.04-3.21]). Mean change in hemoglobin was also clinically similar (-0.5 g/dL misoprostol vs -0.4 g/dL MVA; P<0.01). Heavy bleeding was rare (2.4% misoprostol vs 1.6% MVA; RR 1.55 [95% CI, 0.51-4.68]) following treatment. Nearly all women (96.8% misoprostol vs 98.3% MVA) were satisfied with their treatment but those who received misoprostol were significantly more likely to prefer that method in the future (81.9% vs 62.8%; RR 1.30 [95% CI, 1.19-1.43]).
                The high efficacy, safety, and acceptability of 400-μg sublingual misoprostol indicate that it is analogous to surgery as a first-line treatment for incomplete abortion. Misoprostol might improve post-abortion care when resources are limited and surgical treatment is unavailable.
                Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. A prospective randomized control trial was designed to assess the effectiveness of single dose, 800 microg misoprostol administered p.v. compared with surgical evacuation for the treatment of early pregnancy failure. A total of 80 women with a diagnosis of early pregnancy failure were randomized to study (vaginal misoprostol) and control (surgical curettage) groups. Success of treatment, side-effects as assessed during, immediately after and 10 days after treatment, and patient satisfaction were compared. Intravaginal misoprostol was successful in 82.5% (33 out of 40) of the patients. None of the control group patients required a repeat evacuation. The number of patients who experienced significant abdominal pain following treatment did not differ between the groups. The duration of pain was shorter in the control group; however, they required more analgesics during this short period. The number of patients with significant vaginal bleeding, the duration or severity of bleeding did not show any significant difference between the groups. All 33 patients in the study group who had successful treatment expressed satisfaction, whereas only 58% of the control group did so. In conclusion this randomized control study demonstrated the efficacy and safety of the administration of 800 microg of misoprostol p.v. for the management of early pregnancy failure. Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial to compare the efficacy, adverse effects, and acceptability of misoprostol 800 mcg vaginally administered simultaneously with, or 24 hours after, mifepristone 200 mg orally for abortion in women up to 63 days of gestation.
                The 1,128 participants swallowed mifepristone 200 mg and were then randomized to self-administer misoprostol intravaginally immediately in the office (group 1) or 24 hours later at home (group 2). Subjects returned for an evaluation, including transvaginal ultrasonography, 7+/-1 days after initiating treatment. Women who had not aborted were offered a second dose of misoprostol and returned for another evaluation in approximately 1 week. A phone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication.
                The complete abortion rate for group 1 (95.1%, 95% confidence interval [CI] 93.0-96.8%) was statistically noninferior to that for group 2 (96.9%, 95% CI 95.1-98.2%) (P=.003). The abortion rates between groups did not significantly differ by gestational age. Adverse effects were mostly similar, although nausea, diarrhea, and warmth or chills were significantly more common in group 1.
                Mifepristone 200 mg and misoprostol 800 mcg vaginally used simultaneously is as effective for abortion as compared with regimens using a 24-hour dosing interval.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269568
                I. Mifepristone was recently approved in the United States. Regimens with shorter intervals may be more acceptable. The objective of this study was to determine whether the oral route of misoprostol was as effective as the vaginal route of misoprostol 1 day after mifepristone. A prospective, open-labeled, randomized trial of healthy adult women up to 63 days pregnant and wanting a medical abortion were randomized to use either two doses of oral misoprostol 400 microg taken 2 h apart or misoprostol 800 microg vaginally. Women self-administered misoprostol 1 day after taking one-third of the standard dose of mifepristone (200 mg) orally. Women then returned to the clinic up to 5 days later for a repeat sonogram evaluation. A dose of vaginal misoprostol was administered to women with a continuing pregnancy who then returned 1 day later to Day 15. The primary outcome measures were a complete medical abortion by the first or by the second follow-up visits. Surgical intervention was indicated for continuing pregnancy at the second follow-up visit, excessive bleeding, or persistent products of conception 5 weeks later. One thousand one hundred sixty-eight women were enrolled. Of the 1144 (98%) women who complied with their random assignment, two oral doses of misoprostol (800 microg total) were 90% effective at inducing an abortion by the first follow-up visit, compared with one dose of misoprostol by vagina of 97% (chi(2) = 23.95, p = 0.001). By the second follow-up visit, the complete abortion rate was 95% for oral misoprostol and 99% for vaginal misoprostol (chi(2) = 21.76, p = 0.001). There were minimal differences in side effects. Women preferred the oral route. The trial demonstrated that although two doses of oral misoprostol were effective, the vaginal misoprostol was more effective at inducing an early medical abortion at 1 day after low-dose mifepristone, and the regimen could be extended to 63 days gestation. A prospective randomized controlled trial was conducted to compare the efficacy and side-effects of vaginal versus oral misoprostol in the medical management of incomplete miscarriage.
                Two hundred and one patients who miscarried consented to randomization using computer-generated randomization model prior to treatment. A total of 800 microg of misoprostol was given either vaginally or orally to the randomized subjects. A second dose was repeated 4 h later if the product of conception had not been passed.
                The incidence of complete uterine evacuation following vaginal and oral misoprostol was similar [(58/95) 61.1% versus (67/103) 64.4%]. There was a significantly decreased incidence of diarrhoea [(12/95) 13.6% versus (62/103) 65.3%, P < 0.01] with the use of vaginal misoprostol.
                Vaginal misoprostol was as effective as oral misoprostol in medical uterine evacuation in patients with incomplete miscarriage. There was also a reduction in the incidence of diarrhoea with the use of vaginal misoprostol. This study was conducted to compare the safety, effectiveness and acceptability of 400 mcg sublingual misoprostol and 600 mcg oral misoprostol for treatment of incomplete abortion.
                We used an open-label randomized controlled trial conducted from July 2005 to August 2006 in a large tertiary level maternity hospital in Antananarivo, Madagascar, and a large tertiary level hospital in Chisinau, Moldova. Three hundred consenting women seeking treatment for clinically diagnosed incomplete abortion with uterine size <or=12 weeks since last menstrual period were randomized to misoprostol either 600 mcg orally or 400 mcg sublingually. The primary outcome measure was the complete resolution of clinical signs and symptoms of incomplete abortion without need for surgical intervention. Women were seen for follow-up on Day 7 and, if necessary, on Day 14 to assess abortion status. The study was powered to detect a 7% difference in efficacy with a total of 142 women required in each arm.
                Efficacy rates were 94.6% and 94.5%, for the oral and sublingual routes, respectively (RR: 1.00, 95% CI=0.95-1.06, p=.98). At 1 week follow-up, more than 80% of women had completed abortions (77.8% oral and 84.8% sublingual, p=.12). Mean pain scores were 2.95 and 3.04, respectively, for the oral and sublingual groups. Side effects included abdominal pain, bleeding, headaches and dizziness/weakness with no differences reported between the two groups. Acceptability and satisfaction were high for both routes and women indicated a preference for medical versus surgical treatment if ever needed in the future.
                Both treatment regimens were very effective. Four hundred micrograms of sublingual misoprostol and 600 mcg oral misoprostol appear to have similar safety and effectiveness profiles when used for the treatment of incomplete abortion. A lower 400-mcg misoprostol dose may provide an alternative treatment option as well as have potential benefits in terms of cost. 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 compare the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion in Maputo, Mozambique.
                A total of 270 women with clinically diagnosed incomplete abortions of up to 12 weeks of gestation were randomized to either 600 mug oral misoprostol or MVA. Women were followed-up seven days later to evaluate whether the abortion was complete.
                Success was high for both MVA and misoprostol groups (100% vs 91%, P=0.002). Women in the MVA arm reported fewer side effects but higher pain scores. Women who received misoprostol were significantly more likely to be "very satisfied" with the treatment and willing to choose the method again.
                Although oral misoprostol was less effective than MVA in this study, it was more acceptable to women. Misoprostol is well-suited for use in low-resource settings, and should be promoted as an option for the treatment of incomplete abortion.
The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Women experiencing miscarriage at less than 13 weeks should be offered an informed choice. Future studies should include long-term follow-up.