Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. Role of prostaglandin in the management of prelabour rupture of the membranes at term. Premature rupture of membranes at term with an unfavorable cervix: comparison of expectant management, vaginal prostaglandin, and oxytocin induction. Aggressive or expectant management of labour: a randomised clinical trial. Management of term pregnancy with premature rupture of the membranes and unfavourable cervix. Prelabour rupture of the membranes at term--no advantage of delaying induction for 24 hours. Controlled comparison of induction versus expectant care for prelabor rupture of the membranes at term. A randomized trial of intracervical prostaglandin gel and intravenous oxytocin in prelabor rupture of membranes with unripe cervix at term. Does prostaglandin confer significant advantage over oxytocin infusion for nulliparas with pre-labor rupture of membranes at term? A randomized trial of management of pre-labor rupture of membranes at term in multiparous women using vaginal prostaglandin gel.
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 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. Our objective was to determine the best treatment for parturients at term with an unfavorable cervix and premature rupture of membranes (PROM).
                In this prospective study, 96 women with PROM and an unfavorable cervix were randomized into one of three treatment groups: oxytocin induction, vaginal prostaglandin E2 gel followed by oxytocin, or expectant management.
                Length of labor, cesarean section rate, and maternal/neonatal morbidity were not significantly different. In contrast, the interval from PROM until delivery and length of hospital stay were significantly longer in the expectantly managed group than in the other groups. Four of the patients who received expectant management required delivery because of nonreassuring fetal assessments.
                Expectant management of PROM at term significantly prolongs hospital stay without decreasing the incidence of abdominal delivery or infectious morbidity. There appears to be potential for cord compression in patients managed expectantly without continuous electronic fetal surveillance. To compare labour outcomes using aggressive or expectant management protocols.
                Randomised trial.
                Pretoria Academic Complex, South Africa. It serves an indigent urban population.
                Healthy nulliparous women in active labour, at term, with a health singleton pregnancy and cephalic presentation.
                The women were randomised to either aggressive (n = 344) or expectant (n = 350) management protocols. Aggressive management entailed using a single line partogram, a vaginal examination every two hours and use of an oxytocin infusion if the line was crossed. Expectant management entailed using a two line partogram, with the alert line and a parallel action line four hours to the right, with a vaginal examination every four hours. If the action line was reached, oxytocin was started. The women were reassessed every two hours thereafter. Analgesia was prescribed on request.
                Mode of birth, use of oxytocin and analgesia and neonatal outcome.
                The groups were similar with respect to maternal age, cervical dilation at trial entry, number crossing the alert line and birthweight of the infants. Significantly fewer women managed aggressively had caesarean sections (16.0%) than those managed expectantly (23.4%) (relative risk [RR] 0.68, 95% confidence intervals [CI] 0.50, 0.93). Significantly more oxytocin was used in the aggressive management group, but there was no difference with respect to the use of analgesia or episiotomy or in neonatal outcome with respect to the Apgar score at 1 or 10 minutes. There were three perinatal deaths. One woman was found to have an intrauterine death before trial entry and the other two were in the aggressive management group but did not receive oxytocin. Compliance by staff was poor in the aggressive management group.
                Aggressive management of labour reduces the caesarean section rate in nulliparous women but requires more intensive nursing. Sixty pregnant patients at term, who had premature rupture of the membranes and an unfavourable cervix were randomised to compare expectant management with oxytocin induction and with the use of prostaglandin E2 vaginal tablets for cervical ripening/induction of labour. Patients treated expectantly were placed on bed rest and observed for labour and infection. Patients managed by intervention were given intravenous oxytocin or 2 prostaglandin E2 tablets (0.5 mg) intravaginally every 6 hours. Between the three groups the duration of labour was longer in the oxytocin group and all 6 caesarean sections were performed on patients in this group. There was only 1 case of proven neonatal sepsis; this occurred in the oxytocin group. Patients with prostaglandin cervical ripening had a shorter hospital stay compared with patients treated expectantly. It is concluded that prostaglandin-induced cervical ripening is the method of choice in handling term patients with premature rupture of the membranes and an unfavourable cervix. 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. 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. In order to compare the efficacy of immediate intravenous oxytocin administration and intracervical prostaglandin E2 gel application in premature rupture of membranes with unfavorable cervices at term, 45 term pregnant patients with premature rupture of membranes were randomized into two groups. Twenty women received immediate intravenous oxytocin after cleansing enema while the rest were treated with intracervical prostaglandin E2 gel. Means of maternal age, gestational age, Bishop score at admission and the rates of nulliparity did not show any significant differences between the two groups (p > 0.05). The mean rupture to delivery time was 12.6 +/- 4.4 hours in the oxytocin group and 16.5 +/- 4.5 hours in the prostaglandin group (p < 0.01). Mean birth weights and Apgar scores were insignificant. Cesarean section rates were 24% in the oxytocin group and 5% in the other (p < 0.05). No infectious morbidity was seen in any case. In conclusion, although delivery is delayed with the intracervical prostaglandin approach, cesarean section rate is lowered without an increase in infectious morbidity. 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 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.
Planned management (with methods such as oxytocin or prostaglandin) reduces the risk of some maternal infectious morbidity without increasing caesarean sections and operative vaginal births. Fewer infants went to neonatal intensive care under planned management although no differences were seen in neonatal infection rates. Since planned and expectant management may not be very different, women need to have appropriate information to make informed choices.