A randomised controlled trial of early versus delayed use of amniotomy and oxytocin infusion in nulliparous labour. A controlled trial of a program for the active management of labor. A trial of amniotomy in a Palestinian hospital. Evaluation of different policies for the management of labour. Dysfunctional labour: a randomised trial. A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women. Induction of labour: a randomised clinical trial of amniotomy versus amniotomy with oxytocin infusion. Aggressive or expectant management of labour: a randomised clinical trial. Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour. Early versus delayed oxytocin augmentation in nulliparous women with prolonged labour--a randomised controlled trial. A behavioral intervention to improve obstetrical care. Early versus late amniotomy for labor induction: a randomized trial.
To compare routine amniotomy and early intravenous oxytocin (active management of labour) with a more selective use of amniotomy and oxytocin in women in true labour who received comparable continuous supportive midwifery care.
                Randomised controlled trial of nulliparous clinic patients in spontaneous labour at term.
                Labour and delivery ward of a university teaching hospital.
                Three hundred and six parturients: 152 received active management of labour; 154 were more selectively managed.
                1. Active management: early amniotomy, early use of oxytocin. 2. Selective intervention management: no routine amniotomy and more selective use of oxytocin.
                Use of oxytocin and amniotomy. Labour duration, mode of delivery.
                Maternal characteristics were comparable in both groups. Amniotomy was more often performed (91% versus 57%, P <0.01) and oxytocin more often used (53% versus 27%, P < 0.01) in the active management group. The first stage of labour, however, was only shortened by half an hour in the active management group (254 min versus 283 min, P = 0.087). Caesarean section rate (3.9% versus 2.6%), spontaneous vaginal delivery rate (78% versus 79%) and neonatal outcome were not significantly different between groups.
                Within a set-up of strict labour diagnosis and supportive midwifery care, routine amniotomy and early use of oxytocin offered no advantage over a more selective use of amniotomy and oxytocin in terms of mode of delivery and labour duration. Over the past two decades, the rate of cesarean section in the United States has risen from 5 percent to 25 percent of deliveries, primarily because of the increased frequency of dystocia (arrest of labor). One strategy that has been proposed for increasing the rate of vaginal delivery is a program of active management of labor that encourages early amniotomy, early diagnosis of slow progress in labor, and the use of higher than usual doses of oxytocin; the efficacy and safety of this approach are uncertain, however.
                We conducted a randomized trial in which nulliparous women in spontaneous labor at term were randomly assigned to either active management of labor or traditional management. With active management, amniotomy was performed within one hour of the diagnosis of labor, and when the rate of cervical dilation was less than 1 cm per hour, oxytocin was infused at an initial rate of 6 mU per minute. The dose was increased by 6 mU per minute every 15 minutes (to a maximum of 36 mU per minute) until there were seven contractions every 15 minutes.
                For the women assigned to active management (n = 351), the cesarean-section rate was 10.5 percent, as compared with 14.1 percent for those assigned to traditional management (n = 354, P = 0.18). The 26 percent reduction in the cesarean-section rate was due primarily to a decrease in dystocia. After we controlled for potential confounding variables, the reduction in the rate of delivery by cesarean section was statistically significant (odds ratio for women given active as compared with traditional management, 0.57; 95 percent confidence interval, 0.36 to 0.95). With active management, the average length of labor was shortened by 1.66 hours, principally because of earlier amniotomy and earlier use of oxytocin. There was no increase in maternal or neonatal morbidity, and there were significantly fewer infectious complications in the mothers.
                The program we studied for the active management of labor reduces the incidence of dystocia and increases the rate of vaginal delivery without increasing maternal or neonatal morbidity. This randomised controlled trial of routine amniotomy was carried out in a developing country setting to investigate the effect of this common procedure on the duration of labour, intra-partum interventions and selected newborn and maternal outcomes. In a Jerusalem teaching hospital, 533 multiparous and 157 nulliparous low-risk women were randomised to either amniotomy or intent to conserve membranes. For multiparae, the median duration from randomisation to full dilatation was 95 and 160 min, respectively in the intervention and control arms (p < 0.001); for nulliparae it was 210 and 270 min, respectively (p < 0.001). In both groups, oxytocin was used less in the intervention arms (p < 0.001), and no difference in mode of delivery and immediate outcomes was detected. However, given the risks of this intervention and these study findings indicating an overall short duration of childbirth, amniotomy should be limited to cases of abnormal progress of labour. Various policies of management of prolonged labour have been proposed to prevent its two main consequences--caesarean section and fetal distress. Two randomised controlled trials were organised; the first to assess the value of amniotomy with oxytocin compared to a more conservative approach. The second trial compared the effect of continuous professional support during labour with the intermittent presence of a member of staff. These were multicentre studies in several countries of Europe. Preliminary results of early amniotomy suggested no difference in the rate of operative delivery. Continuous professional support was associated with a significant reduction in operative deliveries. Sixty-one women making slow progress in the active phase of spontaneous labour with intact membranes were randomised to oxytocin and amniotomy, amniotomy only or expectant management. The data show that oxytocin significantly increases the rate of cervical dilatation and shortens prolonged labour, when compared with amniotomy alone and expectant management (P = 0.0144 and 0.0006, respectively). The impact on the operative delivery rate and neonatal outcome is difficult to assess due to the small number of relevant adverse outcomes. Women reported higher satisfaction score in the two groups where intervention followed the diagnosis of dysfunctional labour. Oxytocin is widely used to speed up slow labour, especially in nulliparous women, but randomised trials, apart from one reported only in abstract, have been too small to exclude important effects.
                To test the hypothesis that early use of oxytocin reduces the need for caesarean delivery.
                A randomised controlled trial.
                Twelve obstetric units within the Northern and Yorkshire regions in the North East of England.
                A total of 412 low-risk nulliparous women in spontaneous labour at term, who had been diagnosed with primary dysfunctional labour were recruited from January 1999 to December 2001.
                Immediate oxytocin administration (active group) or oxytocin withheld for up to 8 hours (conservative group).
                Caesarean section and operative vaginal delivery rates. The length of labour measured from the time of randomisation to delivery. The rate of maternal Edinburgh Postnatal Depression Scale (EPDS) greater than 12 (major depression) within 48 hours of delivery.
                The caesarean section rates were 13.5% active versus 13.7% controls (OR 0.98, 95% CI 0.6-1.7). Operative delivery, 24.5% versus 30.9% (OR 0.73, 95% CI 0.5-1.1). The median (interquartile range) randomisation to delivery interval in the active group was 5 hours 52 minutes (3:57-8:28) and in the conservative group 9 hours 8 minutes (5:06-13:16) (P < 0.001). The rate of EPDS >12 was 20% in the active arm versus 15% among controls (OR 1.26, 95% CI 0.7-2.2). There was one perinatal death in each group and no major differences in perinatal outcomes.
                Among nulliparous women with primary dysfunctional labour, early use of oxytocin does not reduce caesarean section or short-term postnatal depression. However, it shortens labour considerably and may reduce operative vaginal deliveries. To compare two methods of induction of labour-amniotomy with oxytocin infusion versus amniotomy alone.
                Prospective randomised clinical trial.
                The department of obstetrics in a Swedish central hospital.
                One hundred and ninety-six pregnant women with indication for induction of labour at term and a favourable cervix (modified Bishop score > or = 6).
                The women were randomised to amniotomy followed by oxytocin infusion after 1 h (group A, n = 98) or amniotomy alone (group B, n = 98). If labour had not ensued on the following morning, after approximately 24 h, the women in group B were given an oxytocin infusion.
                Induction-delivery interval, duration of labour, time spent in delivery ward, oxytocin use, maternal and neonatal clinical outcome.
                Amniotomy combined with early oxytocin infusion resulted in shorter induction-delivery interval (median 6.0 h; 95% confidence interval (CI) 5.0 to 6.5 h) than amniotomy alone (median 9.0 h; 95% CI 7.5 to 10.0 h). This was due to a shorter latent period in the former group (median 2.3 h; 95% CI 2.0 to 3.0 h) compared to the latter (median 4.3 h; 95% CI 3.0 to 5.5 h). The duration of labour stages 1 and 2 were similar in both groups. The time spent in the delivery ward was slightly reduced for women managed by amniotomy alone (median 5.0 h; 95% CI 4.5 to 6.0 h) compared with those managed by the combination of amniotomy and oxytocin infusion (median 6.0 h; 95% CI 5.0 to 6.5 h). Eighty-seven percent in group A and 32% in group B were given oxytocin, and the total oxytocin infusion time was nearly five times longer in group A. No other important effect on maternal or fetal outcomes was demonstrated.
                With regard to safety the results do not warrant recommending either type of labour induction. The minor differences observed between the induction groups justify an individual management policy, with attention paid to both the indication for induction of labour and the woman's choice. 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. To evaluate the impact of labouring in water during first stage of labour on rates of epidural analgesia and operative delivery in nulliparous women with dystocia.
                Randomised controlled trial.
                University teaching hospital in southern England.
                99 nulliparous women with dystocia (cervical dilation rate < 1 cm/hour in active labour) at low risk of complications. Interventions Immersion in water in birth pool or standard augmentation for dystocia (amniotomy and intravenous oxytocin).
                Primary: epidural analgesia and operative delivery rates. Secondary: augmentation rates with amniotomy and oxytocin, length of labour, maternal and neonatal morbidity including infections, maternal pain score, and maternal satisfaction with care.
                Women randomised to immersion in water had a lower rate of epidural analgesia than women allocated to augmentation (47% v 66%, relative risk 0.71 (95% confidence interval 0.49 to 1.01), number needed to treat for benefit (NNT) 5). They showed no difference in rates of operative delivery (49% v 50%, 0.98 (0.65 to 1.47), NNT 98), but significantly fewer received augmentation (71% v 96%, 0.74 (0.59 to 0.88), NNT 4) or any form of obstetric intervention (amniotomy, oxytocin, epidural, or operative delivery) (80% v 98%, 0.81 (0.67 to 0.92), NNT 5). More neonates of women in the water group were admitted to the neonatal unit (6 v 0, P = 0.013), but there was no difference in Apgar score, infection rates, or umbilical cord pH.
                Labouring in water under midwifery care may be an option for slow progress in labour, reducing the need for obstetric intervention, and offering an alternative pain management strategy. To study the effects of early versus delayed oxytocin augmentation on the obstetrical and neonatal outcome in nulliparous women with spontaneous but prolonged labour.
                Randomised controlled study.
                Two delivery units in Sweden.
                Healthy nulliparous women with normal pregnancies, spontaneous onset of active labour, a cervical dilatation of 4-9 cm and no progress in cervical dilatation for 2 hours and for an additional hour if amniotomy was performed due to slow progress.
                Women (n = 630) were randomly allocated either to labour augmentation by oxytocin infusion (early oxytocin group) or to postponement of oxytocin augmentation for another 3 hours (expectant group).
                Mode of delivery (spontaneous vaginal or instrumental vaginal delivery or caesarean section) and time from randomisation to delivery.
                The caesarean section rate was 29 of 314 (9%) in the early oxytocin group and 34 of 316 (11%) in the expectant group (OR 0.8, 95% CI 0.5-1.4), and instrumental vaginal delivery 54 of 314 (17%) in the early oxytocin versus 38 of 316 (12%) in the expectant group (OR 1.5, 95% CI 0.97-2.4). Early initiation of oxytocin resulted in a mean decrease of 85 minutes in the randomisation to delivery interval.
                Early administration of oxytocin did not change the rate of caesarean section or instrumental vaginal delivery but shortened labour duration significantly in women with a 2-hour arrest in cervical dilatation. No other clear benefits or harms were seen between early and delayed administration of oxytocin. Implementation of evidence-based obstetrical practices remains a significant challenge. Effective strategies to disseminate and implement such practices are needed.
                We randomly assigned 19 hospitals in Argentina and Uruguay to receive a multifaceted behavioral intervention (including selection of opinion leaders, interactive workshops, training of manual skills, one-on-one academic detailing visits with hospital birth attendants, reminders, and feedback) to develop and implement guidelines for the use of episiotomy and management of the third stage of labor or to receive no intervention. The primary outcomes were the rates of prophylactic use of oxytocin during the third stage of labor and of episiotomy. The main secondary outcomes were postpartum hemorrhage and birth attendants' readiness to change their behavior with regard to episiotomies and management of the third stage of labor. The outcomes were measured at baseline, at the end of the 18-month intervention, and 12 months after the end of the intervention.
                The rate of use of prophylactic oxytocin increased from 2.1% at baseline to 83.6% after the end of the intervention at hospitals that received the intervention and from 2.6% to 12.3% at control hospitals (P=0.01 for the difference in changes). The rate of use of episiotomy decreased from 41.1% to 29.9% at hospitals receiving the intervention but remained stable at control hospitals, with preintervention and postintervention values of 43.5% and 44.5%, respectively (P<0.001 for the difference in changes). The intervention was also associated with reductions in the rate of postpartum hemorrhage of 500 ml or more (relative rate reduction, 45%; 95% confidence interval [CI], 9 to 71) and of 1000 ml or more (relative rate reduction, 70%; 95% CI, 16 to 78). Birth attendants' readiness to change also increased in the hospitals receiving the intervention. The effects on the use of episiotomy and prophylactic oxytocin were sustained 12 months after the end of the intervention.
                A multifaceted behavioral intervention increased the prophylactic use of oxytocin during the third stage of labor and reduced the use of episiotomy. (ClinicalTrials.gov number, NCT00070720 [ClinicalTrials.gov]; Current Controlled Trials number, ISRCTN82417627 [controlled-trials.com].).
                Copyright 2008 Massachusetts Medical Society. Our purpose was to determine the impact of early and late amniotomy on labor induction with continuous oxytocin infusion at term.
                A total of 209 women admitted for labor induction were randomized to early or late amniotomy. The early amniotomy group (n = 106) had membranes ruptured as soon as it was deemed safe and feasible. The late amniotomy group (n = 103) had membrane rupture performed at > or = 5 cm dilatation. The first 103 women received a continuous oxytocin infusion with incremental adjustments at 60-minute intervals as required. The next 106 women had adjustments every 30 minutes as required. Statistical analysis was confined to concurrent groups.
                Early amniotomy was associated with shorter labor (13.3 vs 17.8 hours, p = 0.001), chorioamnionitis (22.6% vs 6.8%, p = 0.002), and significant fetal umbilical cord compression (12.3% vs 2.9%, p = 0.017). The benefit regarding shortening of labor was limited to women having oxytocin increments every 30 minutes as required (13.3 vs 17.8 hours, p = 0.001). Alternatively, the increase in chorioamnionitis was confined to the 60-minute group (39% vs 11%, p < 0.001), which also demonstrated a trend toward increased moderate and severe variable decelerations (19.6% vs 6.4%, p = 0.08).
                When a protocol of 60-minute increments in oxytocin infusion rate is desired, amniotomy should be performed late in labor to reduce chorioamnionitis and significant umbilical cord compression. Alternatively, if early amniotomy is necessary, oxytocin should be adjusted every 30 minutes as tolerated.
In prevention trials, early intervention with amniotomy and oxytocin appears to be associated with a modest reduction in the rate of caesarean section over standard care.