[Comparison between prostaglandin E2 gel and oxytocin in medically indicated labor induction]. A randomized trial of vaginal prostaglandin E2 for induction of labor. Insert vs. tablet. A randomized trial of management of pre-labor rupture of membranes at term in multiparous women using vaginal prostaglandin gel. [Artificial induction of labor at term for medical reasons. Comparison of 2 technics for labor induction, oxytocin + early artificial rupture of the membranes versus prostaglandin E2 vaginal gel. Open randomized controlled study]. [Multicenter experiences with the intracervical administration of a new PGE2 gel in labor induction]. Induction of labour: a comparison of a single prostaglandin E2 vaginal tablet with amniotomy and intravenous oxytocin. Early labor initiation with oral PGE2 after premature rupture of the membranes at term. Cervical ripening and labor outcome with preinduction intracervical prostaglandin E2 (Prepidil) gel. Induction of labour: the effect of vaginal prostaglandin or i.v. oxytocin--a matter of time only? Prostaglandin E2 gel for cervical ripening in patients with an indication for delivery. Labor characteristics of uncomplicated prolonged pregnancies after induction with intracervical prostaglandin E2 gel versus intravenous oxytocin. A randomized comparison of prostaglandin E2, oxytocin, and the double-balloon device in inducing labor. A simpler approach to labor induction using lipid-based prostaglandin E2 vaginal suppository. Does prostaglandin confer significant advantage over oxytocin infusion for nulliparas with pre-labor rupture of membranes at term? Trial of extra amniotic saline infusion with oxytocin versus prostaglandin E2 pessary for induction of labor. Prostaglandin E2 gel compared to oxytocin for medically-indicated labour induction at term: a controlled clinical trial. Prostaglandin E2 vaginal suppository for induction of labour: an efficient, safe and popular method. Induction of labor by intracervical prostaglandin gel and oxytocin infusion in primigravid women with unfavorable cervix. Comparison of intravenous oxytocin and vaginal prostaglandin E2 gel in women with unripe cervixes and premature rupture of the membranes. Prelabour rupture of the membranes at term--no advantage of delaying induction for 24 hours. Randomized trial of administration of prostaglandin E2 gel for induction of labor in the morning or the evening. A randomized comparison of vaginal prostaglandin E2 with oxytocin plus amniotomy for induction of labour in women with intermediately ripe cervices. Induction of labor utilizing vaginal vs. intracervical prostaglandin E2. Prostaglandin E2 for induction of labor in patients with premature rupture of membranes at term. Cervical ripening before induction of labor: a randomized trial of prostaglandin E2 gel versus low-dose oxytocin. Ripening of the uterine cervix and induction of labour at term with prostaglandin E2 in viscous gel. Double-blind trial of prostaglandin F2alpha and oxytocin in the induction of labour. [15-Methyl-PGF2 alpha vaginal suppository for induction of term labor]. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. A randomized trial of two preparations of vaginal prostaglandin for pre-induction cervical ripening. Role of prostaglandin in the management of prelabour rupture of the membranes at term. Induction of labor by vaginal prostaglandin E2. A randomized study comparing pessaries with vaginal tablets. Labor induction with vaginal misoprostol and extra-amniotic prostaglandin F2alpha gel. A randomized trial comparing vaginal and cervical prostaglandin gel for cervical ripening and labor induction. Mid-trimester termination of pregnancy--a randomised controlled trial of two prostaglandin regimens. Intracervical prostaglandin in postdate pregnancy. A randomized trial. A randomised controlled trial of an oral solution of prostaglandin E2 and oral oxytocin used immediately after low amniotomy for induction of labour in the presence of a favourable cervix. Premature rupture of membranes in nulliparas at term with unfavorable cervices: a double-blind randomized trial of prostaglandin and placebo. The efficiency of prostaglandin E2 vaginal suppositories versus intracervical prostaglandin gel for induction of labor in patients with unfavorable inducibility prospects. Randomised trial of one versus two doses of prostaglandin E2 for induction of labour: 1. Clinical outcome. [Induction of labor. Prostaglandin E2 vaginal tablets compared with intravenous oxytocin for induction of labor in premature rupture of the membranes and immature cervix]. Vaginal misoprostol for induction of labour: a more effective agent than prostaglandin F2 alpha gel and prostaglandin E2 pessary. Premature rupture of membranes near term: induction of labor with endocervical prostaglandin E2 gel or intravenous oxytocin. Randomised trial of outpatient induction of labor with vaginal PGE2 at 40-41 weeks of gestation versus expectant management. Stimulation of labor in cases of premature rupture of the membranes at or near term. A consecutive randomized study of prostaglandin E2-tablets and intravenous oxytocin. Vaginal administration of PGE2 for induction of labor stimulates endogenous PGF2 alpha production. A comparison of oral prostaglandin E2 tablets with intravenous oxytocin for stimulation of labor after premature rupture of membranes at term. A randomized trial of prostaglandin E2 gel and extra-amniotic saline infusion with high dose oxytocin for cervical ripening. Controlled study comparing vaginal prostaglandin E2 pessaries with intravenous oxytocin for the stimulation of labour after spontaneous rupture of the membranes. Controlled trial of induction of labor by vaginal suppositories containing prostaglandin E2. Controlled comparison of induction versus expectant care for prelabor rupture of the membranes at term. Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial. Cervical ripening and induction of delivery by local administration of prostaglandin E2 gel or vaginal tablets is equally effective. Induction of labor with and without primary amniotomy. A randomized study of prostaglandin E2 tablets and intravenous oxytocin. Induction of labor with intravenous oxytocin or vaginal PGE2 suppositories. A randomized study.
The use of prostaglandins (PG) increasingly replaces the "classical" method of induction of labour by means of oxytocin and amniotomy, the last-named method being associated, especially in women with an unripe cervix, with side effects like prolonged labour and a higher rate of obstetric surgery. In this study the point of interest was whether prostaglandins offer any advantages over the classical method in respect of efficacy and maternal and foetal tolerance. 99 patients subdivided into primiparae and multiparae were randomly assigned to group A or B. In group A labour was induced with 1 mg resp. 2 mg PGE2 intravaginally at an interval of 6 hours. In group B the method of induction consisted of intravenous oxytocin and amniotomy. The success rate of induction was almost equal in both groups. However, in those patients where PGE2 induction did not succeed and who could not be delivered within 12 hours the cervical score was significantly improved in comparison to the oxytocin group. Based on the experience reported in the literature, one might speculate that an increased dosage could still improve the results of vaginally administered PGE2 gel. To compare the efficacy and safety of a prostaglandin E2 (PGE2) vaginal insert with PGE2 administered as a vaginal tablet.
                A randomized, observational study was performed. Women requiring induction of labor were randomly assigned to receive either a 10-mg PGE2 vaginal insert (group 1, n = 100) or 3-mg PGE2 tablets twice at six-hour intervals (group 2, n = 100). The primary efficacy outcome variable was vaginal delivery within 24 hours of insertion. The criteria for safety were the occurrence of uterine hyperstimulation, abnormal fetal heart rate patterns, use of beta 2-sympathomimetic drugs and fetal outcome.
                No differences in terms of vaginal delivery or cesarean section within 24 hours of induction were found. The cesarean section rate was 21% in group 1 and 22% in group 2. The interval from insertion of the induction agent to the onset of regular uterine contractions and the insertion-to-delivery interval were not different between the two cohorts. No difference in the frequency of uterine hyperstimulation, use of beta 2-sympathomimetic drugs, abnormal fetal heart rate patterns, fetal outcome, or oxytocin and analgesic requirements were found. In seven of eight patients in group 1 who experienced uterine hyperstimulation, removal of the insert was sufficient to stop it, whereas in group 2, of nine cases, eight needed medical interventions to end hyperstimulation (P = .003).
                The continuous release of PGE2 from the vaginal insert permits controlled induction of labor, and easy removal of the drug in cases of uterine hyperstimulation is possible. To compare conservative management of pre-labor spontaneous rupture of membranes (SROM) with the use of prostaglandin (PG) E2 in healthy parous women at term (gestational age at least 37 weeks).
                An open randomized study was conducted with 100 parous women; 50 were treated conservatively for 24 hours, and 50 were managed actively using PGE2 gel (1 mg), administered at admission and repeated 6 hours later if labor was not established. Both groups received intravenous oxytocin if labor did not start within 24 hours after admission.
                The use of PGE2 gel led to a significant reduction in the mean interval (+/- standard error of the mean) from SROM to onset of labor: 17.26 +/- 1.51 hours in the conservative group versus 6.50 +/- 1.23 in the PGE2 group. A significantly smaller proportion of subjects required oxytocin in the PGE2 group (12 versus 38%, P < .02). The two groups were comparable with respect to analgesic requirements. Within 24 hours of SROM, 80% of the women in the PG group and 56% in the conservative group had delivered (P < .02). Most women delivered vaginally, 96% of those managed conservatively and 100% of those managed actively with PGE2.
                Active management using PGE2 gel in parous women with pre-labor SROM significantly improves the time to delivery without influencing the cesarean rate or fetal-maternal infective morbidity. Labor induction for medical reasons is a situation rather well-controlled by the combination: "oxytocin-amniotomy" when the cervix is favorably open. However, new induction techniques are currently under study, especially vaginal administration of PGE2 which presents the advantage of being simple to administer and better accepted by the patients. This study compared the classical technique, oxytocin perfusion and early artificial rupture of the membranes, with the vaginal administration of PGE2 gel (first dose: 1 mg, second dose 1 or 2 mg, six hours later). The success rate of both techniques is comparable, approximately 70 p. cent. Also, the times between amniotomy and delivery are identical, approximately 5 hours. On the contrary, the lapses of time between the onset of the induction and the delivery, vary significantly, being always longer in the PGE2 group. However, the dose of vaginal PGE2 gel as well as the time of artificial membrane rupture could be modified in order to decrease the delay of the effect. With the participation of four Swiss obstetric clinics, medically indicated inductions of birth (with living fetuses) were performed using a new, stable PGE2 gel, and documented according to a uniform protocol. The study was conducted to investigate the efficacy of 0.5 mg of PGE2, in 2.5 ml of a vehicle (Triacetin) not yet commercially available, for local cervical maturation (n = 41). Thirty-nine patients selected by prospective randomization, in whom birth was induced conventionally, served as a control group. The efficiency of the prostaglandin gel alone or respectively with additional administration of oxytocin was evaluated on the basis of the clear changes in the cervical findings observed within 12 or respectively 24 hours, the spontaneous births, or, in the case of cesarean deliveries, according to the pelvic score. Application of PGE2 alone led to impressive changes of the cervix score and, in 34 of the 41 cases, to regular contractions after an average time of 87 minutes. After 12 hours, prior to administration of oxytocin, 43% of the patients were already delivered. The combination of locally applied PGE2 gel with conventional oxytocin induction significantly increases the number of successful inductions. The percentage of unsuccessfully attempted inductions was reduced to 24% in the PGE2 gel group as compared to 44% in the control group. In a randomized controlled study of 100 women of low parity and favourable induction features, induction of labour by means of a single vaginal tablet containing 3 mg of prostaglandin E2 (PGE2) was compared with the conventional method of amniotomy and intravenous oxytocin. Four of the patients (8%) who received the prostaglandin tablet required additional intravenous oxytocin to achieve delivery. The prostaglandin group had a longer mean overall induction-delivery interval but a shorter amniotomy-delivery interval than the oxytocin group. One patient in the PGE2 group and two in the oxytocin group required caesarean section. The PGE2 treated patients expressed a higher level of satisfaction with their method of induction, they required less analgesia, had less blood loss at delivery and their babies had a lower incidence of neonatal jaundice. Two groups of healthy women at term, who were not in labor 3 hours after premature rupture of the membranes, were studied. In one group labor induction with oral prostaglandin E2 (PGE2) was begun 3 hours after rupture, and in the other group intravenous oxytocin induction was begun 12 hours after rupture. PGE2 was successful in initiating active labor in 88% of women treated. Of the women who were observed for 12 hours, one-half began labor spontaneously during that time. Women in whom labor was induced with PGE2 given 3 hours after rupture of the membranes had a shorter interval of rupture to delivery, a lower cesarean section rate, and shorter postpartum hospitalization. Although significant bradycardia did not occur in fetuses of those women given PGE2, 10% of infants whose mothers were receiving oxytocin were delivered by cesarean section for this reason. It is concluded that oral PGE2 is safe and effective for induction of labor in women with premature membrane rupture. The benefits, to both mother and fetus, of a shorter latent period are discussed. Delivery with an unfavorable cervix using oxytocin is frequently unsuccessful. Used widely in Europe and increasingly in this country, locally applied prostaglandin E2 appears to improve labor induction. The present study prospectively evaluated the efficacy and safety of a prostaglandin gel (0.5 mg) placed intracervically. The use of the gel, when compared to a control group who received no pretreatment prior to labor induction, resulted in improved Bishop scores (7.5 +/- 1.0 vs. 1.8 +/- 0.3, P less than 0.0001), reduced induction to delivery intervals (10.1 +/- 2.1 vs. 20.6 +/- 2.0 hours), reduced oxytocin infusion duration (10.0 +/- 2.1 vs. 20.0 +/- 2.3 hours. P less than 0.0001) resulting in a lower cesarean delivery rate, 26 vs. 47 per cent (P greater than 0.05). Thirty-two per cent of patients receiving the prostaglandin gel labored and delivered within 12 hours and required no oxytocin. In addition, the use of prostaglandin E2 gel appeared safe in that no patient experienced an untoward reaction. Two cases of uterine hyperstimulation occurred that required uterine tocolysis but were not associated with fetal distress. The use of prostaglandin gel appears to be a safe and effective method to improve cervical inducibility in patients undergoing induction for a variety of maternal and fetal indications. Ninety-one pregnant women with unfavourable cervix (Bishop score no higher than 6) were randomly allocated to induction of labour with either prostaglandin E2 suppositories 2.5 mg 1-2 a day or i.v. oxytocin 4-32 mU/min. The induction procedure was carried on for 2 days. For statistical comparison of efficacy, life table analysis and the logrank test were used with vaginal delivery as the aimed 'event'. Prostaglandin suppositories were more efficient after 12 h (p less than 0.025) and 24 h (p less than 0.005), whereas no difference in efficacy was observed after 48 h. Vaginal delivery was obtained within 48 h in 74% of the women in the prostaglandin group and in 70% in the oxytocin group. No difference was observed in methods of delivery or neonatal Apgar scores, though, in neonates delivered vaginally within 2 days, lowered umbilical artery blood pH values were found after prostaglandin E2 suppositories (p less than 0.05). The patients attitude toward the method of induction was highly in favour of the prostaglandin suppositories. Prostaglandin E2 suppositories are considered excellent for induction of labour if delivery has to be within 24 h, whereas the two methods are equally effective after 48 h. To determine if labor can be induced safely and efficiently in patients with a medical or obstetric indication for delivery before 41 completed weeks of gestation by pre-induction cervical ripening with prostaglandin (PG) E2 gel.
                One hundred eighteen women with confirmed indication for induction of labor before 41 completed weeks were randomized in a double-blind fashion to either intracervical PGE2 gel or placebo before induction by a standard oxytocin protocol. Data regarding the change in Bishop score, interval to complete dilation, maximal oxytocin dose required to establish labor, and route of delivery were collected. Apgar scores and umbilical artery pH were also recorded.
                The maximum oxytocin dose required to establish progressive labor was significantly lower in the PGE2 group (10.06 +/- 8.50 versus 13.35 +/- 9.27 mU/minute, P = .014). The cesarean rate was also significantly lower in the PGE2 group (13.1 versus 31.6%, P = .016).
                Pre-induction intracervical deposition of 1 mg PGE2 gel decreased the amount of oxytocin required to induce progressive labor and decreased the cesarean rate in patients who had medical or obstetric indications for delivery before 41 completed weeks. This was accomplished without negative effect on Apgar score or umbilical artery pH. Labor characteristics after intracervical application of 0.5 mg prostaglandin (PG) E2 gel (n = 83) versus intravenous administration of oxytocin (n = 82) for labor induction were investigated in uncomplicated prolonged pregnancies with unripe cervix. The induction to delivery time as well as the total oxytocin dose were significantly reduced in the PGE2 group (p < 0.001). Cesarean sections, instrumental deliveries and fetal distress had the same frequency, but the failures of trial were significantly higher in the oxytocin group than in the PGE2 group (20.7 vs. 6%, p < 0.01). Twenty-four percent of women needed a second PGE2 dose, and almost half of the women in the PGE2 group experienced 'spontaneous' labor. More neonates in the oxytocin group had 5-min Apgar scores < 7 (p < 0.05). Intracervical PGE2 gel application is superior to intravenous oxytocin in terms of shortening the induction-delivery interval and increasing the frequency of successful vaginal delivery. In addition, it is safe for mother and fetus. To compare the efficacy of three methods for ripening and dilating the unfavorable cervix for induction of labor.
                Pregnant women having an indication for induction of labor with a singleton vertex fetus, intact membranes, and Bishop score of no more than 4 were randomized to one of three induction methods: intravaginal prostaglandin (PG) E2 tablets (3 mg) followed by a second dose if labor did not start; continuous intravenous oxytocin drip; or the Atad Ripener Device, with inflation of both balloons and removal after 12 hours. For all patients, the cervix was assessed by the same investigator before induction and 12 hours later.
                Thirty subjects were included in the PGE2 group, 30 in the oxytocin group, and 35 in the Atad Ripener Device group. The postpartum course was comparable in all. The change in Bishop score in the PGE2 and Atad Ripener Device groups was significantly better than in the oxytocin group (median and range of 5[0-9] and 5[0-7], respectively, versus 2.5 [0-9]; P < .01). Cervical dilation more than 3 cm was more frequent in the Atad Ripener Device group compared with both the PGE2 and oxytocin groups (85.7 versus 50 and 23.3%, respectively; P < .01). The trial of induction failed in only two patients (5.7%) in the Atad Ripener Device group, compared with six (20%) in the PGE2 and 16 (53.3%) in the oxytocin groups (P < .001). Mean (+/- standard deviation) induction-to-delivery interval was 21.3 +/- 7.0 hours in the Atad Ripener Device group, 23.2 +/- 12.5 hours in the PGE2 group, and 28.2 +/- 14.7 hours in the oxytocin group. The success rate for vaginal delivery was significantly better in the Atad Ripener Device and PGE2 groups compared with the oxytocin group (77.1 and 70%, respectively, versus 26.7%; P < .01).
                The Atad Ripener Device had a significantly better success rate for cervical dilation and a lower failure rate than those for PGE2 and oxytocin. The PGE2 and Atad Ripener Device groups had better results than the oxytocin group in regard to Bishop score change and induction-to-delivery interval. The Atad Ripener Device may be a superior method for cervical ripening and labor induction in patients with unfavorable cervices. The outcome of labor induced by use of a glyceride-based vaginal suppository of prostaglandin E2 (PGE2) inserted 3 hours before amniotomy, when the cervix is favorable, has been assessed. Using 5 mg PGE2 for primigravidas and 2.5 mg for multigravidas, 63% of the former and 81% of the latter established labor and were delivered of their infants without oxytocin augmentation, allowing ambulation during early labor. No maternal complications were detected as a result of the PGE2 treatment. Compared with patients undergoing conventional induction by amniotomy and immediate oxytocin titration there was no difference in the duration of labor, with a few patients establishing labor and giving birth quickly with both induction methods. Fetal distress was less common following PGE2 treatment than following conventional induction, with three patients in each group requiring delivery by cesarean section. Cephalopelvis disproportion in the second stage of labor requiring cesarean section to deliver occurred more frequently in the prostaglandin-treated group, possibly as a result of reduced upper segment contractility in the first stage of labor with subsequent poor fetal head molding. Epidural analgesia and postpartum hemorrhge were both reduced following PGE2-induced labor. Ninety-four nulliparous women with a poor cervical score (less than 6) who had premature rupture of membranes at term were randomized by sealed envelope into two groups. One group received immediate stimulation of labor with oxytocin infusion. The second group received two prostaglandin E2 (PGE2) 3-mg pessaries 4 hours apart, followed by oxytocin infusion, if necessary. The interval between initiation of therapy to onset of labor was significantly longer in the PG group, but the length of labor was similar in both groups. The maximum dose of oxytocin needed was significantly higher in the oxytocin group. The cesarean delivery rate in the oxytocin group was 14.9%, compared with 19.1% in the PG group (not significantly different). All seven cesareans in the oxytocin group and seven of nine in the PG group were for failed stimulation of labor. Neonatal Apgar scores at 1 and 5 minutes and admission to the neonatal intensive care unit were similar in the two groups. The incidence of maternal and neonatal infection was small and was not different in the two groups. The use of PGE2 3-mg pessaries 4 hours apart, followed by oxytocin infusion if necessary, did not confer any benefit over the use of intravenous oxytocin in obstetric or neonatal outcome when both agents were started a few hours after admission. To determine the effectiveness and safety of cost-effective extra-amniotic saline infusion (EASI) and simultaneous intravenous oxytocin infusion versus prostaglandin E2 vaginal pessary (PGE2) for induction of labor.
                Prospective randomized comparative study.
                Labor room at the Mother and Child Health Centre, PIMS, Islamabad from September 2000 to December 2001.
                Women with singleton alive pregnancies and Bishop score < or =6, requiring induction of labor at > or =37 weeks gestation were randomly assigned to induction either with PGE2 3 mg vaginal pessary in two doses 6 hourly or EASI for 12 hours with simultaneous intravenous oxytocin infusion. Artificial rupture of membranes was done 12 hours post-induction and oxytocin infusion started in PGE2. Main outcome measures were induction delivery interval and the mode of delivery. Secondary outcome measures were the change in modified Bishop score 6 hours postinduction and neonatal outcome in the two induction modes.
                After 4 exclusions, 100 women were recruited in each arm. Mean induction delivery interval was 11.1 and 14.3 hours (p=.00) in PGE2 and EASI respectively. The cesarean rate was 11% and 15% (p=0.4) in PGE2 and EASI respectively. Mean Bishop score at induction was 3.2 in PGE2 and 3.1 in EASI, while after 6 hours it was 4.8 and 6.8 (p=0.00) respectively. Mean APGAR scores at 1 and 10 minutes were identical that is 6.2 and 8.6 respectively.
                Both the modes of induction were equally safe and effective in terms of the mode of delivery and APGAR score. EASI, however, had more rapid cervical ripening and shorter induction delivery interval. A clinical trial was carried out to compare the efficacy and tolerance of two modes of induction of labour: vaginally administered prostaglandin E2 gel vs intravenous perfusion of synthetic oxytocin. Fifty women with pregnancy at or near term in whom prompt vaginal delivery was clinically indicated were divided at random into sub-groups of 25 each. Initial dose of PGE2 gel was 1 mg followed by another application of 1 mg or 2 mg 6 hours later in case active labour stage has not been reached. Progressive oxytocin perfusion began with 1 mU/min., being increased gradually every 20 minutes until efficacious uterine dynamics were attained. Data were recorded on entry of age, parity, gestation age, cervical dilatation, Bishop score, indication for induction. Continuous materno-foetal monitoring was carried out during the induction period. Results were evaluated from induction/delivery time, type of delivery, maternal and foetal condition, and any side-effects which developed. Apart from a higher number of instrumental deliveries in the PGE2 gel series, which was not related to the induction method, there was no significant difference between any of the variables evaluated, both methods producing active labour in approximately 70% of the patients within 12 hours. The authors stress, however, the convenience, both for patients and hospital staff, of the administration of an intravaginal induction agent over a systemic therapeutic method of induction. Two different methods for induction of labour were randomly used in 100 women with a favourable cervix. The patients were treated with either prostaglandin vaginal suppositories containing 2.5 mg PGE2 in a base of Witepsol S55 (Dynamit Nobel) or intravenous infusion of oxytocin. The PGE2 vaginal suppository was significantly more efficient than the intravenous infusion of oxytocin in relation to the time interval from the start of induction of labour to delivery. Also the percentage of women who delivered within 48 hours (success rate) was higher in the suppository group. Significantly more women in the suppository group found this induction method recommendable. The rate of Cesarean Section for failed induction of labor and maternal and fetal compilations are high when labor is induced in a nulliparas women with an unripe cervix by amniotomy and oxytocin infusion. Prostaglandins (PG) in different forms have been used for ripening the cervix with an aim of reducing these problems. A prospective randomized trial was performed on one hundred primigravid women between 37 and 42 weeks of gestation with singleton pregnancy, cephalic presentation and unfavorable cervix (Modified Bishop Score < or = 5) in the department of Obstetrics & Gynaecology of Institute of Postgraduate Medicine & Research from 1st May 1996 to 30th April 1997. In this study the efficiency of prostaglandin E2 intracervical (PGE2 IC) gel in induction of labor in a group of primigravid women with unripe cervix was assessed and compared with another group with similar characteristics using oxytocin infusion and artificial rupture of membrane (ARM). The Modified Bishop Score (MBS), interval between IOL and onset of labor and the duration of labor after insertion of PGE2 gel was significantly different from those of oxytocin infusion group. But the Apgar Score at 1 & 5 min had shown no statistically significant difference. Any significant difference could also not be detected in the mode of delivery between the two induction group. The proportion of emergency Cesarean Section (CS) was high in the oxytocin infusion group than that of in the prostaglandin group. There was also no significant difference regarding the acceptability of both the induction methods. To induce cervical priming and labor, 20 nulliparous term pregnant women with premature rupture of the membranes and unfavorable cervical states were randomly given either oxytocin intravenously or 4 mg prostaglandin E2 in gel intravaginally. One of ten women receiving oxytocin had a favorable cervical state within five hours and vaginal delivery within 24 hours after the start of the infusion compared with six of ten women after prostaglandin E2 gel application. This difference is statistically significant (P less than .01). The number of instrumental deliveries was nine (four cesarean sections and five vacuum extractions) in the oxytocin-treated patients compared with only two vacuum extractions in women who received prostaglandin E2 gel. This difference is also statistically significant (P less than .01, Fischer exact test). In a subsequent open study, 4 mg prostaglandin E2 gel was applied vaginally to 17 term pregnant women of mixed parity with premature rupture of the membranes and unfavorable cervixes. In 12 women a favorable cervical state was achieved within five hours after gel application, and all these women were delivered within 24 hours. None of the women required cesarean section but two required delivery by vacuum extraction. There were no perinatal losses, but two infants in the oxytocin-treated group had Apgar scores less than 7 at five minutes. At pediatric follow-up after two and six months, all infants were normal. In both obstetric and perinatal outcome prostaglandin E2 gel thus seems to be superior to oxytocin for labor induction in term pregnant patients with premature rupture of the membranes and unfavorable cervixes. We performed a prospective randomized study to compare maternal and fetal outcomes in pregnancies with prelabour rupture of the membranes (PROM) at term with early induction of labour or expectant management, 126 women with singleton pregnancy, cephalic presentation and gestational duration > or = 37 weeks, were randomized either to immediate induction of labour with oxytocin (Group 1) (n=52), or conservative management (Group 2) (n=74). Women who constituted Group 2 were divided into 2 groups. The first group (Group 2A) (n=25) included women in whom spontaneous labour did not begin after a waiting period of 24 hours, in which case labour was induced with oxytocin i.e. expectant management. The second group consisted of women (Group 2B) (n=49) in whom labour began spontaneously within 24 hours. The base Caesarean section rate was significantly higher in Group 2 (28.4%) (p<0.05). The rates of Caesarean section in the Groups 1-2A-2B were 19.2%, 60%, and 12.2%, respectively for nulliparous and parous women together. The rate of fetal distress was significantly higher in Group 2 (p<0.05). For determining maternal outcomes, the other parameters such as clinical chorioamnionitis, fever before or during labour, receiving antibiotics before or during labour, postpartum fever, analgesia, anaesthesia did not differ in Groups 1 and 2. Women in Group 1 went into active labour sooner, had fewer digital vaginal examinations, had a shorter interval between membrane rupture and delivery, and spent less time in the hospital before delivery than those in Group 2 (p<0.05). Babies in Group 2 were more likely to receive antibiotics, and more likely to stay in an intensive care nursery for more than 24 hours, and more likely to receive ventilation after initial resuscitation than those babies in Group 1. For developing apnoea and hypotonia, there was no significant difference between Groups 1 and 2. However, for babies in Group 2A there was a significant difference. We conclude that immediate induction of labour with oxytocin does not increase the risk of Caesarean section, compared with a practice of expectant management. Women at term with prelabour rupture of the membranes should therefore be reassured that immediate induction with oxytocin currently appears to be the best policy with respect to maternal and neonatal morbidity. To compare the outcome of induction of labor and patient's preferences using a protocol with the first dose of prostaglandin E2 endocervical gel in the evening versus a protocol with the first dose in the morning.
                We performed a randomized trial comparing administration of prostaglandin E2 endocervical gel in the morning with administration of prostaglandin E2 gel in the evening, followed if necessary by a second dose being given after six hours if labor had not started or the cervix was still unripe. Formal induction of labor by amniotomy and oxytocin infusion was performed the morning after the initial prostaglandin E2 dose. Patients' preferences were assessed using a questionnaire that was completed after delivery.
                Tertiary care hospital in the Netherlands with 1,600 deliveries per year.
                One-hundred and twenty-six women with viable singleton pregnancies at term who had induction of labor with prostaglandins.
                Time of delivery (daytime, evening or night) and patient's satisfaction.
                Fifty-eight women were allocated for administration of gel in the morning, whereas 68 had their gel in the evening. Administration of gel in the evening did not significantly reduce delivery between 23.00 hours and 08.00 hours, although there was a reduction in delivery between 23.00 hours and 08.00 hours in nulliparae. None of the multiparous women delivered between 18.00 hours and 23.00 hours after induction of labor in the evening. The relative risk for delivery by vacuum or forceps was increased after allocation of gel in the evening (4.2; 95% confidence limits 1.4 to 13). Patients' preferences favored administration of gel in the morning.
                There was no benefit in starting induction of labor with prostaglandin E2 in the evening, compared with starting in the morning. To compare the effects of oxytocin and amniotomy or vaginal prostaglandin E2 (PGE2) for induction of labour.
                We conducted a randomized clinical trial. Eligible for the trial were women with normal pregnancy, parity 0-3, with intact membranes, >40 weeks of gestation documented by ultrasound examination before 20 weeks gestation, observed in a network of 13 general and teaching hospitals in Italy. Inclusion criteria were cervical Bishop's score 5-7, less than six uterine contractions per hour, single pregnancy, cephalic presentation, no history of cesarean section and uterine surgery. Eligible women were randomly assigned by phone to oxytocin plus amniotomy (163 women) or vaginal PGE2 2 mg, two doses at 6-h intervals (157 women).
                Overall, 50 women (15.6%) delivered by cesarean section, 22 (13.5%) randomized to oxytocin, and 28 (17.8%) randomized to PGE2 (not significant). Twelve hours after randomization, induction had failed in 26 women of the 163 randomized to oxytocin plus amniotomy (21.6%) and 34 out of the 157 randomized to PGE2 (15.9%): the difference was not significant. Neonatal outcome was similar in the two groups.
                This study did not find marked differences in labour and neonatal outcome between women randomized to oxytocin plus amniotomy or vaginal PGE2. A shorter induction delivery interval in the group receiving amniotomy and oxytocin after PGE2 priming was observed. To compare the efficacy of intracervical vs. vaginal prostaglandin E2 (PGE2) gel for induction of labor.
                Sixty-eight women scheduled for elective induction of labor at term were randomized to receive either 0.5 mg intracervical PGE2 (I/C group, n = 37) or 2 mg vaginal PGE2 gel (Vag group, n = 31) on a 6-hourly basis for a maximum of three doses.
                Three participants who delivered by cesarean section soon after gel administration were excluded from further analysis. Twenty-nine of 30 (97%) in the Vag group were successfully induced compared with 23 of 35 (66%) in the I/C group (P < 0.01). The induction-active labor intervals were 8.0 +/- 5.4 h for the Vag group and 23.1 +/- 27.6 h for the I/C group (P = 0.002). The induction-delivery intervals were 12.4 +/- 6.3 h for the Vag group and 29.8 +/- 29.1 h for the I/C group (P = 0.001). Uterine hyperstimulation and perinatal outcome were similar in both groups.
                Vaginal PGE2 was more efficacious than intracervical PGE2 in inducing labor. A prospective study comparing three management schemes for patients at term with premature rupture of membranes was performed.
                One hundred forty patients were randomized to one of three study groups: prostaglandin E2, placebo, or oxytocin. Patients randomized to prostaglandin E2 and placebo received vaginal suppositories containing 3 mg prostaglandin E2 or glycerin only, respectively; suppositories were administered in a double-blind fashion, on one or two occasions, 6 hours apart. Oxytocin was given only if labor was not established after 12 hours or to augment inadequate labor. In patients randomized to oxytocin labor was induced with intravenous oxytocin. The time interval to delivery, delivery outcome, and complications were analyzed.
                Patients receiving prostaglandin E2 were more likely to be in labor after one suppository and to be delivered without the addition of oxytocin when compared with placebo. The time interval to delivery was shorter with prostaglandin E2 and oxytocin induction versus placebo ("expectant management"). The incidence of maternal infection was lowest in patients with labor induced by prostaglandin E2. Although the overall cesarean section rate was low, there was a trend toward a lower rate with prostaglandin E2 induction. No adverse effects were observed with prostaglandin E2.
                Prostaglandin E2 can be used successfully to induce labor after premature rupture of membranes at term with greater ease of administration when compared with oxytocin. The purpose of this study was to compare prostaglandin E2 gel and a low-dose infusion of oxytocin for cervical ripening before labor induction.
                A total of 158 women were randomized to receive either two intracervical doses of 0.5 mg prostaglandin E2 gel 6 hours apart or 12 hours of intravenous oxytocin up to 4 mlU/min. After cervical ripening labor was induced with high-dose oxytocin infusion and amniotomy.
                There was no difference between the prostaglandin E2 and low-dose oxytocin groups in the likelihood of being in labor or having a Bishop score favorable for induction after ripening (64.2% vs 52.0%, p = 0.12) or in the incidence of vaginal delivery (75.9% vs 74.7%). Prostaglandin E2-treated patients were delivered sooner (20.2 +/- 8.1 hours vs 25.0 +/- 10.5 hours, p = 0.002). Among delivered patients the likelihood of vaginal delivery within 24 hours was greater with prostaglandin E2 ripening (63.7% vs 47.2%, p = 0.04), but there was no difference at 36 hours (76.2% vs 75.0%). Uterine hyperstimulation and fetal distress during ripening occurred only in the prostaglandin E2 group, at a rate of 4.8%.
                After cervical ripening with prostaglandin E2 gel or low-dose oxytocin vaginal delivery can be expected in three fourths of patients within 24 to 36 hours. We recommend that patients with an unfavorable cervix who require delivery undergo cervical ripening and induction of labor rather than automatic delivery by cesarean section. In order to achieve ripening of the uterine cervix or induce labour in patients at term with an unfavourable cervical state, 1 mg of prostaglandin E2 (PGE2), suspended in a viscous gel, was instilled into the cervical canal. In a pilot study, 41 patients received the PGE2-gel. Twenty-three of these, (56%), went into labour, and delivery occurred without further stimulation within 15 hours. In the remaining 18 patients, there was a marked improvement of the cervical state, which changed from an average (modified) Bishop score of 2.5 to 6.1 within 24 hours. In a double-blind study comprising 20 nulliparae, 10 received gel containing PGE2 and 10 gel without prostaglandin. Cervical state did not change significantly (Bishop score 3.6 and 4.0) after 24 hours in patients receiving placebo gel. In those receiving PGE2 gel, 8 went into labour and were delivered without further induction within 13 hours. Two patients showed an increase in Bishop score from 3 to 6 and 7, respectively, after 24 hours. They were then induced by oxytocin and delivery occurred after 8 and 10 hours. The results suggest that administration of PGE2 intracervically can induce ripening of the cervix in patients at term with an unfavourable cervical state, and thus facilitate delivery. In a random double-blind trial in 28 pregnant women at term, labour was induced with either prostaglandin F2alpha or oxytocin given by intravenous infusion. The results showed that prostaglandin F2alpha was as active as oxytocin and induction was successfully carried out in 24 patients; 3 patients had a caesarean section because of an obstructed labour and 1 patient on oxytocin did not have regular contractions after 10-hours' infusion although she delivered spontaneously 2 days later. No difference was found in the induction--delivery interval in the 8 patients in each group who had early amniotomy (first 90 minutes). No adverse effects were noted in either mother or the child. The authors recommend that to avoid side-effects the dosage of 20 mug prostaglandin F2alpha per minute should not be exceeded and that, although no cardiotocographic abnormalities were noted, this method of control should be used. The results of intravaginal 15-methyl PGF2 alpha (PG05) were compared with gemeprost (ONO-802, PGE1 analogue) pessary and oxytocin intravenous infusion for induction of labor at term. A total of 99 primipara with singleton pregnancy and cephalic presentation, accepted for induction, was randomly allocated into 3 groups: group 1, PG05 0.25 mg (n = 33), group 2, ONO-802 0.125 mg (n = 33), and group 3, oxytocin i.v. (n = 33). Among these, 30 cases had plasma PGs (PGE2 and PGF2 alpha) concentration determined before and after induction. Successful treatment was defined as active labor starting within 24 hours following induction or an increase of cervical Bishop score > 3. The success rates were not significantly different among the 3 groups (PG05 88%, ONO-802 100%, and oxytocin 79%), (P > 0.05). No significant difference existed in the plasma prostaglandin concentrations as well. It is suggested that PG05 may be used for induction of labor at term. As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. It is not known whether inducing labor will reduce this risk or whether one method of induction is better then another.
                We studied 5041 women with prelabor rupture of the membranes at term. The women were randomly assigned to induction of labor with intravenous oxytocin; induction of labor with vaginal prostaglandin E2 gel; or expectant management for up to four days, with labor induced with either intravenous oxytocin or vaginal prostaglandin E2 gel if complications developed. The primary outcome was neonatal infection. Secondary outcomes were the need for cesarean section and women's evaluations of their treatment.
                The rates of neonatal infection and cesarean section were not significantly different among the study groups. The rates of neonatal infection were 2.0 percent for the induction-with-oxytocin group, 3.0 percent for the induction-with-prostaglandin group, 2.8 percent for the expectant-management (oxytocin) group, and 2.7 percent for the expectant-management (prostaglandin) group. The rates of cesarean section ranged from 9.6 to 10.9 percent. Clinical chorioamnionitis was less likely to develop in the women in the induction-with-oxytocin group than in those in the expectant-management (oxytocin) group (4.0 percent vs. 8.6 percent, P<0.001), as was postpartum fever (1.9 percent vs. 3.6 percent, P=0.008). Women in the induction groups were less likely to say they liked "nothing" about their treatment than those in the expectant-management groups.
                In women with prelabor rupture of the membranes at term, induction of labor with oxytocin or prostaglandin E2 and expectant management result in similar rates of neonatal infection and cesarean section. Induction of labor with intravenous oxytocin results in a lower risk of maternal infection than does expectant management. Women view induction of labor more positively than expectant management. To compare two prostaglandin (PG) E2 preparations for pre-induction cervical ripening in a randomized clinical trial.
                Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women. Outcomes assessed were induction failure, need for labor augmentation, pain relief requirements, fetal heart rate (FHR) abnormalities, operative delivery rate, induction-to-delivery interval, neonatal condition, and occurrence of uterine hyperstimulation.
                There was no statistical difference in pre- and post-dose cervical scores. Compared with the tablet group, women in the gel group were more likely to have significant FHR abnormalities in early labor (odds ratio [OR] 4.77, 95% confidence interval [CI] 1.15-19.5) requiring cesarean delivery. Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group (chi 2 = 4.31, P < .05). Compared with the gel group, women in the tablet group were significantly more likely to require operative delivery for poor progress in labor (OR 2.83, 95% CI 1.20-7.24). Other clinical outcomes were identical, with no significant differences in the overall rate of failed induction, cesarean delivery, rate of assisted delivery, requirement for oxytocin infusion, induction-to-delivery interval, pain relief requirements, or neonatal condition.
                When compared with the PGE2 tablet, the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome. Whereas the gel was associated with an increase in significant FHR abnormalities, the tablet was associated with an increase in the rate of operative delivery for poor progress in labor. To compare conservative versus prostaglandin management of prelabour rupture of the membranes (PROM) in healthy primigravid women at term.
                A prospective randomized study.
                Labour Ward, Aberdeen Maternity Hospital.
                230 primigravidae at terms with PROM, 115 allocated to be treated conservatively and 115 to be managed with prostaglandin treatment.
                In the conservatively managed group the women were observed for up to 24 h after hospital admission with PROM. The actively managed group had PGE2 gel (2 mg) instilled into the posterior fornix and if contractions had not commenced, a further dose of PGE2 gel (1 mg) was instilled 6 h later. In both groups, if labour had not established 24 h after admission, intravenous oxytocin was given in escalating doses.
                PROM to delivery interval, oxytocin augmentation, mode of delivery, maternal and neonatal infective morbidity.
                There was a significant reduction in the PROM to delivery interval in the women managed actively with PGE2 gel and fewer women in the PGE2 group required oxytocin augmentation (31% vs 51%). The two managements groups were comparable for intrapartum analgesia, antibiotic treatment, babies requiring admission to the special care nursery unit and delivery by caesarean section.
                The early use of prostaglandin is associated with a significant reduction in PROM to delivery interval without a significant increase in infective morbidity or caesarean section rate. However, the advantages of the conservative approach should not be overlooked. More work is still needed in the management of those women where uterine activity fails to establish within 24 h after PROM. A prospective randomized study of 267 pregnant women was undertaken to compare the efficacy of a pharmacy-prepared 3-mg prostaglandin E2 (PGE2) vaginal suppository with a 3-mg PGE2 vaginal tablet for induction of labor and cervical ripening. No statistically significant difference in success frequency was found between the two groups, either on the first day (72% and 74%, respectively; p greater than 0.05) or on the second day (89% in both groups). There was an equal proportion of women requiring oxytocin augmentation in the two groups, but the slower releasing properties of the vaginal tablet were reflected in a longer mean induction--delivery interval of about 4 h for this group. In both the pessary and the vaginal tablet groups, women who had not gone into labor on the first day showed a statistically significant increment in the Bishop score on the morning of the second day. The frequency of cesarean section was the same in both groups, but instrumental deliveries were more frequent in the vaginal tablet group. It is concluded that PGE2 vaginal tablets--a chemically stable alternative to pharmacy prepared pessaries--appear to be effective as regards cervical ripening as well as for labor induction. To compare the effectiveness of vaginally administered misoprostol with extra-amniotic prostaglandin F2alpha (PGF2alpha) gel for induction of labor.
                A randomized controlled trial, with women allocated to receive either misoprostol 50 microg intra-vaginally or extra-amniotic PGF2alpha gel 5 mg, was conducted in Harare Maternity Hospital. A total of 152 women were admitted for induction of labor with a term singleton, pregnancy and cephalic presentation were recruited. The main outcome was duration of induction.
                There were no differences in the characteristics of women in the two groups at recruitment. In the misoprostol group there was a significantly reduced need for augmentation of labor with oxytocin (OR=0.36; 95% C.I. 0.17-0.73) and delivery by cesarean section for failure to progress (OR=0.11; 95% C.I. 0.00-0.88). The risk for duration of induction to vaginal delivery exceeding 12, 18 or 24 h was reduced by 18%, 38% and 68%, respectively, but only the risk for duration >24 h was significantly reduced (OR=0.32; 95%C.I. 0.11-0.91). The mean duration of induction was shorter in the misoprostol group, 15.2 vs. 23.6 h (P=0.02). There were no differences in fetal outcome.
                Misoprostol 50 microg was associated with less use of oxytocin in labor, a shorter induction to delivery interval and fewer cesarean sections for failure to progress when compared with extra-amniotic PGF2alpha gel. To compare the effectiveness of intravaginal and intracervical prostaglandin E2 (PGE2) gel for cervical ripening, defined as an increase of 3 or greater in the Bishop score, and for induction of labor.
                Women with Bishop score 4 or less were assigned randomly to receive either 2 mg PGE2 intravaginally (n = 125) or 0.5 mg intracervically (n = 122). If the Bishop score was 4 or less, another dose of PGE2 was given after 6 hours, and up to two additional doses were given 6 hours apart on the second day. An oxytocin infusion was begun when the Bishop score was 5 or greater in absence of spontaneous labor, or if labor had not begun on the third day.
                Baseline characteristics of the two groups were similar. Survival analysis showed that time from PGE2 application, to obtain an increase of 3 or greater in the Bishop score, to vaginal delivery was significantly shorter with intravaginal PGE2 (logrank test: P = .003 and < .001 after stratification for parity, respectively). Thirty-one percent of women in the intravaginal gel group required oxytocin for labor induction compared with 63% in the intracervical group (P < .001). There were no significant differences in relation to cesarean delivery rate, Apgar scores at 5 minutes, and arterial umbilical cord pH, although the power of our study was limited to detect differences in proportions of adverse outcomes.
                Vaginal PGE2 gel is more effective than intracervical gel for cervical ripening and labor induction. To determine the more applicable of two ways of prostaglandin induction currently in use in second trimester induced abortions for congenital or chromosomal abnormalities.
                A prospective randomised controlled trial.
                Department of Obstetrics and Gynaecology, Tygerberg Hospital, CP.
                Twenty consecutive patients admitted for termination of pregnancy for congenital or chromosomal abnormalities between 14 and 26 weeks' pregnancy duration.
                Patients were randomly selected to receive either 1.5 mg prostaglandin E2 (PGE2) gel extra-amniotically or 25 mg prostaglandin F2 alpha (PGF2 alpha) intra-amniotically. Patients in both groups received oxytocin to a maximum dosage of 120 mU per minute if they had not aborted 18 hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 hours after commencement of treatment, management was considered unsuccessful.
                Proportion of successful inductions and complications.
                Complications of management were rare and did not differ between the two management groups. However, there were significantly more failures in the group who received intra-amniotic PGF2 alpha (7 v. 2 patients) as well as a significantly higher need for oxytocin in this group (10 v. 4 patients).
                With promising drugs such as prostaglandin analogues and anti-progesterones not universally available, methods of induction suitable to the local situation should be sought. Extra-amniotic PGE2 seems more suitable than intra-amniotic PGF2 alpha because of a shorter induction-to-delivery time without increased morbidity. A study was designed to see if incorporating intracervical administration of prostaglandin could affect the outcome of postdate pregnancies. All patients with verified dates, at least 41 6/7 weeks pregnant and enrolled in an antepartum testing schedule were randomized in a double-blind fashion to receive either 0.5 mg of prostaglandin E2 (PGE2) suspended in methylcellulose or a placebo of the gel alone. The gel was inserted directly into the cervical canal after the patient had a reactive/negative contraction stress test. The patient was then observed on an external fetal monitor for an hour before going home. A total of 23 patients received PGE2, and 20 received the placebo. Results were analyzed for the following: change in the Bishop score, lag time from dosage to delivery, spontaneous versus induced labor, cesarean section rate, length of labor and neonatal outcome. There were no significant differences between the groups except in the incidence of patients going into labor within 72 hours. The results indicate that, in general, 0.5 mg of intracervical PGE administered at greater than or equal to 41 6/7 weeks without subsequent oxytocin induction of labor did not appear to significantly alter the obstetric outcome. A randomised controlled trial was carried out in 50 primigravidae and 50 multigravidae to compare the effectiveness in induction of labour after low amniotomy of prostaglandin E2, given as an oral solution, and oxytocin, given as buccal tablets. The results showed that in dosages recommended by the manufacturers, both oxytocic preparations were almost equally effective. With oral oxytocin, once labour had been established and dosage was left to the discretion of the staff, there appeared to be a potentially dangerous tendency to continue giving large doses despite adequate uterine contractions. The authors comment that this was probably the reason why oxytocin-treated multigravidae having normal deliveries within 24 hours had labours significantly shorter on average than those of other successfully induced patients. To determine whether the use of a prostaglandin (PG) E2 3-mg pessary followed by a delay of 12 hours before stimulation of labor with oxytocin improves obstetric outcome compared with the use of a placebo pessary.
                One hundred fifty-five nulliparas at term with poor cervical scores (modified Bishop score below 6 of 10) and premature rupture of membranes (PROM) were recruited for this double-blind, placebo-controlled randomized trial. On admission to the study, either a PGE2 pessary or an identical-appearing placebo pessary was inserted into the posterior fornix. If labor did not start in the next 12 hours or if symptoms and signs of infection were evident, labor was induced with oxytocin infusion. Assignment was unblinded at the end of the study, and details of the labor and maternal and neonatal outcome in women who received a PG pessary were compared with those who received a placebo pessary.
                Women receiving a PG pessary were significantly less likely to require stimulation of labor at the end of 12 hours than were those given a placebo pessary (37 versus 58%, P = .002). The mean time between admission to study and delivery was significantly shorter in the PG group compared with the placebo group (15 versus 19 hours, P = .01). The rate of cesarean delivery was not statistically different in the two groups (13.9% with PG versus 15.8% with placebo).
                In nulliparas with poor cervical scores who present with PROM at term and no evidence of infection or obstetric complications, use of a PGE2 pessary resulted in more women establishing labor earlier, with a resultant reduction in the admission-to-delivery interval, compared with the use of a placebo pessary. The cesarean delivery rates in the two groups were similar, and there were no significant differences in neonatal outcome. Two different applications of prostaglandin E2 for induction of labor were randomly used in 113 women with an unripe cervix; 57 women were given prostaglandin suppositories each containing 2.5 mg PGE2 in a basis of Witepsol S55 (Dynamit Nobel), another 56 women were treated with intracervical gel containing 1 mg PGE2 in 5 g hydroxypropylmethyl cellulose. The treatment was repeated after 4 h if the cervix was still unripe, and the procedure was repeated the following day if the cervix was still unfavorable. Cesarean sections was performed within 48 h after the start of induction and before the second stage of labor in 8 women in the suppository group and 7 women in the intracervical gel group. Of the remaining 98 women, 73% (34/48 women) in the suppository group and 36% (18/50 women) in the cervical gel group had delivered within 24 h (p less than 0.01). After 48 h, 88% (42/48 women) in the suppository group and 74% of the women (37/50 women) in the cervical gel group had delivered (p greater than 0.05). The induction-delivery interval in the suppository group was half that found in the cervical gel group. There was no significant difference between the two groups in the use of instrumental vaginal deliveries and cesarean sections nor was there any difference with regard to fetal distress. The post-delivery condition of the newborn was similar in the two groups. No side-effects were reported in either of the two groups. To compare the outcome of induction of labour using a single versus two doses of prostaglandin E2 vaginal gel.
                Prospective randomised trial comparing a single dose of prostaglandin E2 2 mg vaginal gel in the evening with two doses of prostaglandin E2 (2 mg), the second being given after six hours if labour had not started or the cervix was still unripe. Amniotomy and oxytocin titration were performed when necessary for both protocols. Nulliparae and multiparae were analysed separately by treatment intention.
                A maternity unit in a district general hospital annually delivering > 6000 women.
                Nine-hundred and ninety-five women with viable singleton pregnancies and cephalic presentation at term without previous history of caesarean section who were advised to have labour induced with prostaglandins.
                Need for formal amniotomy and oxytocin augmentation, use of epidural analgesia, rate of intrapartum interventions, mode of delivery and neonatal condition at birth.
                For multiparae two prostaglandin doses resulted in a significant reduction in the need for formal amniotomy (15% vs 30%) and oxytocin augmentation (28% vs 38%) compared with those receiving a single dose; there was no significant difference for nulliparae. Other interventions during labour, length of labour, and mode of delivery were similar in both protocols. Failed induction occurred only in nulliparae and was similar in both protocols (1%). There was no discernible difference in fetal or neonatal outcome although passage of meconium was more common in labour if two doses had been given, as was neonatal admission to the special care baby unit.
                There was little clinical benefit from inducing labour with two doses of prostaglandin E2 at a six-hour interval, compared with a single dose. There may be financial advantages with a two-dose regimen. In a material of 88 patients with premature rupture of the membranes and unripe cervix, a comparative investigation was undertaken to compare the effects of prostaglandin E2 (PGE2) vaginal tablets and intravenous oxytocin on induction of labour. The patients were subdivided at random into two groups: 42 patients treatment with PGE2 and 46 treatment with intravenous oxytocin. The results did not reveal any significant differences in the numbers of successful inductions regardless of the Bishop score at the commencement of stimulation but the duration of induction was found to be briefer in the oxytocin group. No significant differences were observed in the numbers of instrumental interventions in the two groups nor in the frequencies of side effects and in the employment of analgesics. Treatment with PGE2 vaginal tablets is considered to be more acceptable by the patients and easier for the staff to use. The tablets were just as safe and reliable in use as intravenous oxytocin for induction of labour in cases of premature rupture of the membranes and Bishop scores less than 6, but the duration of induction was significantly longer. To compare labour outcome in women who had labour induced with PGF2 alpha gel, PGE2 vaginal pessary or misoprostol administered intravaginally or orally.
                Unmasked randomised controlled trial.
                Department of Obstetrics and Gynaecology, University of Zimbabwe, Harare.
                Women with a singleton foetus in cephalic presentation after 37 weeks gestation admitted for induction of labour who were randomised to prostaglandin F2 alpha gel (n = 76), prostaglandin E2 pessary (n = 75) and misoprostol administered either intra-vaginally (n = 128) or orally (n = 127).
                Primary outcome was induction to delivery interval. Secondary outcomes included use of oxytocin during labour, mode of delivery, duration of labour, neonatal condition at delivery and maternal complications.
                Four hundred and six women admitted for induction of labour with a singleton foetus in cephalic presentation after 37 weeks gestation were enrolled. To estimate the risk with induction using other agents the odds ratio and 95% confidence interval was calculated using the group that received prostaglandin F2 alpha gel as referents.
                The women were comparable for baseline characteristics. Compared to prostaglandin F2 alpha gel, the need for augmentation with oxytocin in labour was significantly reduced in women induced with prostaglandin E2 pessary (OR 0.46; 95%CI 0.23 to 0.93), vaginal misoprostol (OR 0.34; 95%CI 0.18 to 0.63) and oral misoprostol (OR 0.42; 95%CI 0.22 to 0.78). There was no difference in mode of delivery. There was a significantly reduced risk (OR 0.20; 95%CI 0.04 to 0.86) of Caesarean section (CS) for failure to progress in the vaginal misoprostol group. Labour induced with misoprostol and prostaglandin E2 pessary was significantly shorter than in prostaglandin F2 alpha gel. Vaginal misoprostol significantly shortened the induction to delivery interval. There were more admissions to the neonatal unit in the misoprostol groups.
                Compared to prostaglandin F2 alpha gel, misoprostol and prostaglandin E2 pessary had reduced need for oxytocin and a shorter duration of labour. Effects of misoprostol on the foetus need further investigation before it is used as a routine agent for induction of labour. We have studied the influence of endocervical application of 0.4 mg prostaglandin E2 (PGE2) in gel on the clinical outcome of pregnancies of at least 36 weeks' duration complicated with premature rupture of the membranes (PROM) and unripe cervix, (modified Bishop score of 7 or less). There were 579 women in the study. The PGE2 gel was applied within the first 12 hours after PROM. The first 60 women were randomly divided into controls given oxytocin infusions and experimental subjects given PGE2 gel. All others were given PGE2 gel, and the results were compared with those obtained in patients with similar criteria who were treated with oxytocin infusions during the preceding year. The clinical outcome was significantly better in the PGE2-treated patients than oxytocin-infused patients. PROM to delivery interval and the incidence of operative deliveries were significantly reduced. No adverse effects on the neonates were observed and the incidence of neonatal infection declined. It is concluded that cervical ripening with PGE2 gel in patients with PROM and unripe cervix near term significantly improves the outcome for both mother and child. Two hundred consecutive women with uncomplicated pregnancies, at or within 4 days of their expected date of confinement, were prospectively randomized into 2 groups. One group had expectant management, with twice weekly surveillance tests, while the other group had 3 mg of vaginal prostaglandin E2 as outpatient treatment. There were 104 women in the expectant group and 70 in the induction group (26 women allocated to induction preferred no treatment). The average number of days to delivery was 1.6 in the induction group and 5.2 in the expectant group (p < 0.001). While meconium was much less frequent in the induction group (p < 0.002), all other outcome measures, including cesarean section rates, incidence of macrosomia, and Apgar scores, were similar in the two groups. Prostaglandin E2-tablets were compared to intravenous oxytocin for the stimulation of labor in 201 patients at or near term, with premature spontaneous rupture of the membranes without labor activity for 6 hours after the escape of fluid. The patients were randomly allocated; 99 were treated with PGE2-tablets (0.5-1.5 mg/hr) and 102 with intravenous oxytocin (7.5-45 mIU/min). The treatment was ineffective in the PGE2 group in 3 cases; these were treated successfully with intravenous oxytocin. In the oxytocin group, 3 patients were delivered by cesarean section for reasons not associated with the drug. A significant difference was found in the stimulation-delivery time, in favor of intravenous oxytocin. Although PGE2 tablets are a safe and convenient alternative to intravenous oxytocin, the investigation showed that intravenous oxytocin is preferable in cases of premature rupture of the membranes with more than 6 hours without labor activity. Prostaglandin E2 is effective for induction of labor but many preparations exist using a variety of vehicles from which the active ingredient may not be equally available. Plasma concentrations of bicyclic PGE2 metabolite (PGEM) and 13, 14-dihydro, 15-keto PGF2 alpha (PGFM) were measured following administration of a 3mg PGE2 vaginal tablet or 1mg PGE2 vaginal gel to twenty-four parous women with favorable induction features, randomly allocated to receive one or other preparation. PGEM increased rapidly following both administration of the 3mg PGE2 vaginal tablet and the 1mg PGE2 vaginal gel, reaching a peak within 40 minutes of PGE2 administration. The maximal rise in PGEM in the gel group correlated directly with the change in cervical score and inversely with the need for augmentation with oxytocin and the induction-delivery interval. A secondary rise in PGFM was noted in both groups 3-4 hours following PGE2 administration. The magnitude of the increase in PGE2 may be important in the clinical response to PGE2 administration, while PGE2 absorption may switch-on endogenous PGF2 alpha production, similar to what is seen in spontaneous labor. Sixty-nine patients (48 primigravidae and 21 multigravidae) with 12 hours of spontaneous premature rupture of membranes (PROM) after 36 weeks gestation were randomly allocated to receive either prostaglandin E2 (PGE2) oral tablets or intravenous oxytocin to stimulate labor. The two treatments were compared regarding stimulation - delivery interval (SDI), analgesic requirements, maternal and fetal side effects, and patient acceptability. The mean SDI was shorter in the oxytocin group, but without statistical significance. Analgesic requirements and fetal side effects were similar in the two groups, but there was a higher incidence of nausea and vomiting in those patients receiving the maximum dose (1 mg hourly) of PGE2. On subjective assessment, clinicians considered oxytocin to be more effective (p less than 0.05), while midwives felt both regimes to be equally helpful. PGE2 oral tablets were significantly (p less than 0.05) more acceptable to the patients, who preferred the convenience of oral dosing, the absence of an i.v. line and the increased mobility. It is concluded that PGE2 tablets are a safe and effective method of stimulating labor following PROM, and highly acceptable to parturients. In those women in whom labor has not been established within 8 h of initiating PGE2 therapy, or in whom gastric side effects are troublesome, intravenous oxytocin should be substituted. Our purpose was to compare the efficacy of extra-amniotic saline infusion plus high dose oxytocin with prostaglandin E2 intracervical gel (Dinoprostone) for preinduction cervical ripening.
                166 nulliparous women with term pregnancies, vertex presentation, intact membranes and a Bishop score < or = 4 referred for labor induction were randomly assigned to receive a 0.5 mg PGE2 intracervical gel and extra-amniotic saline infusion (EASI) plus high-dose oxytocin. Changes in the Bishop scores, labor progress, various labor end points and outcomes of labor were assessed. Data were analyzed using chi2 analysis or the Student t-test.
                151 women were studied after 15 exclusions, 75 were assigned to PGE2, and 76 to EASI. The groups were similar in age, race, indication for induction and gestational age. The EASI group had a significant improvement in Bishop score and greater dilation. The mean time to vaginal delivery was 11.4+/-4.8 hours and 18.9+/-6.4 hours for the EASI and PGE2 groups respectively (P=0.001). The cesarean delivery rate was not significantly different between the two groups (25% for the EASI group; 34.6% for the PGE2 group). The cesarean rate due to failure to progress, fetal labor intolerance, and maternal and neonatal outcomes were similar in the two groups.
                Preinduction cervical ripening with EASI plus high dose oxytocin resulted in greater changes in Bishop score, and shorter time to normal vaginal delivery than with PGE2 gel in nulliparous women, without increasing the cesarean rate due to failure to progress or fetal labor intolerance. In a prospective randomized study, 36 patients with spontaneous rupture of the membranes of greater than or equal to 4 h duration were stimulated with 3 mg vaginal prostaglandin E2 pessaries or intravenous oxytocin. Oxytocin stimulation was associated with shorter labours and a lower incidence of abnormal cervimetric progress. Of the patients given prostaglandin pessaries, 40% required a second dose after 4 h for slow progress; 45% of the primigravidae subsequently developed abnormal labour which was corrected by augmentation with oxytocin in all cases. One caesarean section was carried out for disproportion, and the remaining 35 patients were delivered vaginally. Prostaglandin pessaries were not associated with an increased incidence of hyperstimulation or sepsis. In conclusion, although PGE2 pessaries are safe in spontaneous rupture of the membranes, intravenous oxytocin is more efficient in stimulating labour. A group of 84 women at 39-43 weeks of pregnancy were randomly allocated to a blind trial of induction of labor with vaginal suppositories containing inert material or either 0.2 mg or 0.4 mg of prostaglandin E2. The suppositories were self-administered every two hours during waking hours on two successive days until labor started or 15 had been used. Side-effects were absent. Labor was established within 48 hr of insertion of the first suppository in 9.3% of control patients, 65.4% of those treated with 0.2 mg PGE2 and 85.7% of those treated with 0.4 mg PGE2. The mean Apgar scores in the three groups were the same. The mean total dose of PGE2 were 2.0 mg (0.2 mg group) and 2.3 mg (0.4 mg group). It is concluded that vaginal PGE2 is an effective and acceptable method of inducing labor at term. This randomized clinical trial compared oxytocin induction of labor with expectant care for 48 hours after prelabor rupture of the membranes at term. Women at term with prelabor rupture of the membranes for at least 8 hours were assigned at random to induction with oxytocin or to expectant management for 48 hours followed by induction if necessary. Of 168 eligible women, 123 (73%) agreed to participate. More women in the induction group (23%) than in the expectant group (10%) had operative delivery, either cesarean section or instrumental vaginal delivery. In the induction group 41% received analgesia versus 24% in the expectant group (p < 0.005). There was no difference in the rate of maternal and neonatal infection between groups and sepsis was not observed. The active policy of oxytocin induction exposed the mother to a higher risk of operative delivery and a less comfortable labor than the 48 hours expectant care option. To determine which of three methods of cervical ripening resulted in the lowest cesarean rate in women with unfavorable cervices and indications for labor induction.
                Consenting women with singleton gestations, vertex presentations, and unfavorable cervices (dilatation under 2 cm and effacement under 75%) were randomly assigned to laminaria and standard intravenous oxytocin, serial doses of intracervical prostaglandin (PG) E(2) gel (Prepidil, Pharmacia & Upjohn, Inc., Kalamazoo, MI) 0.5 microg every 6 hours for two doses followed by oxytocin if indicated, or extra-amniotic saline infusion and oxytocin.
                An interim analysis after recruitment of 321 subjects, 67% of the planned sample, found similar cesarean rates for the three groups (laminaria 36%; PGE(2) gel 33%; saline infusion 29%; P =.59); however, the mean randomization-to-delivery interval was significantly longer in the PGE(2) group. Stochastic curtailment, as part of the interim analysis, indicated a low likelihood of achieving a statistically significant difference in cesarean rates between PGE(2) gel and the other two groups. Therefore, we completed the study with saline infusion and laminaria. The saline infusion and laminaria groups had similar preinduction characteristics. The cesarean rates were similar (saline infusion 25.4% versus laminaria 30.3%; P =.32), but the mean interval from randomization to delivery was shorter in the saline infusion group (18.0 versus 21.5 hours, P =.002). There were no significant differences in selected maternal and neonatal morbidities.
                Cervical ripening with extra-amniotic saline infusion, PGE(2), or laminaria resulted in comparable cesarean rates in women with an unfavorable cervix and indications for labor induction. Extra-amniotic saline infusion had the shortest randomization-to-delivery interval without increasing maternal or neonatal morbidity. 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. A comparative study of labor induction has been performed on 471 consecutive patients. Primary amniotomy was performed in 227 cases, and 103 of these patients were stimulated, 57 patients with PGE2 tablets and 46 with oxytocin. In the remaining 124 cases labor was induced within 4 hours without medical stimulation. Primary amniotomy was omitted in 244 cases, as the head was not engaged and the cervix was unripe. After random allocation to the treatment groups 125 patients received PGE2 tablets (ProstinR), and 119 patients received oxytocin intravenously. After 2 days of stimulation without primary amniotomy, delivery was induced in 83 per cent of the patients receiving PGE2 and in 84 per cent of the patients receiving oxytocin. All patients on whom primary amniotomy had been performed were delivered on the first day. There was no difference in the success rate between PGE2 and oxytocin treatments in patients with the same Bishop score. The performance of amniotomy at the beginning of induction led to a significantly lower total dose as well as a lower maximal dose of PGE2 and oxytocin. There was no difference in the duration of active labor in patients receiving PGE2 or oxytocin. There were no differences in the incidence of fetal distress and low Apgar scores between the different groups. No serious side effects occurred. Vomiting and diarrhea in 14 patients (8 per cent) receiving PGE2 was in contrast to 3 patients with these symptoms (2 per cent) in the oxytocin group. Oral administration of PGE2 is a convenient, effective and safe alternative to oxytocin for the induction of labor; however, PGE2 was not found superior to oxytocin in cases with a low Bishop score. Thirty-eight term pregnant women with a moderately unfavorable cervix (cervical score 4-5 p.) were randomly given intravenous oxytocin (Group A) or 3 mg PGE2 as a vaginal suppository (Group B) for labor induction. Eight out of 19 in Group A and 17 out of 19 in Group B gave birth vaginally within 24 h. The remaining 11 women in Group A had still an unfavorable cervix after 24 h. They were then given 3 mg PGE2 as a vaginal suppository and all but one had given birth vaginally without complications within 24 h. In Group B only 2 were still undelivered after 24 h. Both had a favorable cervix and were delivered vaginally within 12 h after intravenous infusion of oxytocin. The number of instrumental deliveries in Group A was one cesarean section and two vacuum extractions and in Group B three vacuum extractions. One woman in Group B reported nausea and vomiting and in one had strong uterine contractions in the second stage of labor. Otherwise no side effects were registered. All babies were born in good condition with Apgar scores greater than or equal to 7. In conclusion, vaginal application of 3 mg PGE2 as a suppository seems to be more effective than intravenous infusion of oxytocin for labor induction in women with half-ripened cervices, i.e. cervical scores of 4-5 p.
Induction of labour using mechanical methods results in similar caesarean section rates as prostaglandins, for a lower risk of hyperstimulation. Mechanical methods do not increase the overall number of women not delivered within 24 hours, however the proportion of multiparous women who did not achieve vaginal delivery within 24 hours was higher when compared with vaginal PGE2. Compared with oxytocin, mechanical methods reduce the risk of caesarean section.