Comparison of 12- and 72-hour expectant management of premature rupture of membranes in term pregnancies. Prelabour rupture of the membranes at term and unfavourable cervix; a randomized placebo-controlled trial on early intervention with intravaginal prostaglandin E2 gel. A randomized trial of management of pre-labor rupture of membranes at term in multiparous women using vaginal prostaglandin gel. Management of premature rupture of membranes at term: randomized trial. Prelabour rupture of the membranes at term--no advantage of delaying induction for 24 hours. [Premature rupture of the fetal membranes--an active or expectant approach in management of this obstetrical problem]. Role of prostaglandin in the management of prelabour rupture of the membranes at term. Controlled comparison of induction versus expectant care for prelabor rupture of the membranes at term. A comparison of early and delayed induction of labor with spontaneous rupture of membranes at term. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group.
To compare 12-hour and 72-hour expectant management of premature rupture of membranes (PROM) in singleton term pregnancies.
                In a prospective, nonrandomized study, 566 low-risk women with singleton term pregnancies presenting with PROM were assigned to either 12-hour or 72-hour expectant management. Patients who had not entered labor at the end of the assigned period were induced with oxytocin. The pregnancy outcome of both methods was compared with regard to infectious complications and method of delivery.
                There was no statistical difference in the rate of chorioamnionitis between the 12-hour and 72-hour expectant management groups (11.7 versus 12.7%; relative risk [RR] 0.9, 95% confidence interval [CI] 0.6-1.5; P = .83). Cesareans were performed to a similar degree in both groups (4.7 versus 6.7%; RR 0.7, 95% CI 0.3-1.4; P = .39). Fifty-five percent of the 12-hour group underwent oxytocin induction, compared with 17.5% of those in the 72-hour group (RR 5.8, 95% CI 3.9-8.5; P < .001). Women undergoing induction after 72-hour expectant management had an increased risk of cesarean delivery compared with those after a 12-hour wait (RR 5.9, 95% CI 2.3-15.1; P < .001). Overall, women in the 12-hour group had shorter admission-to-discharge times than the 72-hour group (5 versus 6 days, 95% CI of the difference 0.6-1.3; P < .01).
                Regimens of 12-hour and 72-hour expectant management of PROM are comparable regarding infectious complications and pregnancy outcome. However, the longer wait prolongs the interval to delivery and increases hospitalization costs. Fifty nine women with prelabour rupture of membranes, unfavourable cervix and no evidence of infection or fetal distress were randomized formally to receive prostaglandin E2 (3mg) gel or sterile K-Y Jelly intravaginally. Conservative expectant management was followed for the next 24 hours. The subsequent management of the labour followed departmental protocol. The women who received prostaglandin went into labour sooner and were delivered earlier but the duration of labour was not significantly different. There were no significant differences in other clinical outcomes. There was 1 case of uterine rupture in the prostaglandin group. We conclude that early intervention with prostaglandin E2 gel intravaginally confers no advantage compared with conservative management except for earlier confinement in this group of patients. 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. We hypothesize that expectant management in the presence of premature rupture of membranes at term would result in a lower cesarean birth rate with no increase in maternal, fetal, or neonatal infection.
                Term patients who consented to the study were randomly allocated either to expectant management for 48 hours or to induction of labor 8 hours after premature rupture of membranes. Premature rupture of membranes was confirmed by sterile speculum examination of the vagina. Patients randomized to expectant management were transferred to antenatal care and were not examined vaginally until they went into labor. Patients randomized to induction of labor had induction with oxytocin 8 hours after premature rupture of membranes.
                Two hundred sixty-two patients were randomized to the expectant management and induction of labor groups. The cesarean birth rate and the clinical diagnosis of postpartum endometritis was not significantly different in the two groups. Pathologic diagnosis of chorioamnionitis and funisitis, however, was significantly greater in the expectant management group (p < 0.05). Eight of the 15 babies with funisitis were admitted to the neonatal intensive care unit for therapy (two in the induction of labor group and six in the expectant management group, p < 0.05).
                Expectant management did not reduce the incidence of cesarean birth and increased the pathologic diagnosis of funisitis and newborn requirements for neonatal intensive care. 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. A prospective investigation and comparative analysis of clinical and microbiological results have been performed as to point to some facts of possible significance in solving the dilemmas concerning the problem of pregnant women with premature rupture of the membranes.
                Intensive clinical monitoring of the course, methods and complications of the labor was undertaken in 75 pregnant women with premature rupture of the membranes and term delivery. Smears from the vagina, cervix, amnion and amniotic fluid were obtained from each pregnant woman, as well as nasal and throat smears from newborn infants in order to microbiological analysis. According to the method of labor treatment, the investigated patients (n = 75) were distributed into 2 groups. Early induction of labor was applied in 39 pregnant women (labor induction 6 h following rupture of the membranes) and expectatively treated 37 pregnant women (the control of pregnant women until initiation of the spontaneous contractions associated with antibiotic prophylaxis).
                Duration of labor (period from rupture of the membranes to the delivery and from the initiation of regular contractions to the delivery) was significantly shorter (p < 0.01) in the induced labor group. Cesarean section was performed in 18.4% od labors in the first and in 13.5% of labors in the second group. Chorioamnionitis occurred in 7.9% in the first and in 21.6% in the second group during the labor (p < 0.05). The incidence of puerperal and neonatal infection was lower in the first investigated group (7.9% and 5.2%) than in the second group (18.9% and 16.2%). Positive microbiological finding was recorded in 13.2% of pregnant women from the first group and in 27.0% from the second group (p < 0.05).
                From the medical point of view it is reasonable to apply early induction of labor in pregnant women at more than 34 weeks' gestation. In pregnant women of less than 34 weeks' gestation, the expectant management of labor is recommended only in the next 48-72 hours. 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. 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. The management of women with spontaneous rupture of membranes at term in the absence of labor and with a cervix unfavorable for induction of labor is controversial. In this randomized study of 182 patients, we report the effects of delayed versus early induction of labor on maternal and neonatal outcome. Qualifying patients not in labor at 6 hours after spontaneous rupture of membranes were randomized to either immediate oxytocin induction (86 women) or expectant management with oxytocin induction at 24 hours if labor had not occurred spontaneously (96 women). The cesarean section rate did not differ between the two groups. Women in the delayed group had significantly longer hospitalization (P less than .003), and their infants were significantly more likely to receive antibiotics (P = .006). Infectious morbidity (positive cultures or x-ray-documented pneumonia) occurred in five of the neonates in the delayed group, all of whose mothers had an initial digital cervical examination, but in none of the neonates in the early group, a difference that did not reach statistical significance (P = .061). Five (28%) of 18 infants from the delayed group whose mothers had received an initial digital cervical examination became infected, compared with none of the 78 infants from the delayed group whose mothers did not have digital examinations (P less than .001). We conclude that there is no advantage to delaying induction of labor when women present at term with spontaneous rupture of membranes. 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.
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.