METHODS: : Nulliparas with uncomplicated PROM at term, a Bishop score less than or equal to 6, and who required labor induction were recruited for a double-blind randomized trial. Participants were randomly assigned to 3-mg dinoprostone pessary and oxytocin infusion or placebo and oxytocin infusion. A cardiotocogram was performed before induction and maintained to delivery. Dinoprostone pessary or placebo was placed in the posterior vaginal fornix. Oxytocin intravenous infusion was commenced at 2 milliunits/min and doubled every 30 minutes to a maximum of 32 milliunits/min. Oxytocin infusion rate was titrated to achieve four contractions every 10 minutes. Primary outcomes were vaginal delivery within 12 hours and maternal satisfaction with the birth process using a visual analog scale (VAS) from 0 to 10 (higher score, greater satisfaction).
RESULTS: : One hundred fourteen women were available for analysis. Vaginal delivery rates within 12 hours were 25 of 57 (43.9%) for concurrent treatment compared with 27/57 (47.4%) (relative risk 0.9, 95% confidence interval 0.6-1.4, P=.85) for oxytocin only; median VAS was 8 (interquartile range [IQR] 2) compared with 8 (IQR 2), P=.38. Uterine hyperstimulation was 14% compared with 5.3%, P=.20; overall vaginal delivery rates were 59.6% compared with 64.9%, P=.70; and induction to vaginal delivery interval 9.7 hours compared with 9.4 hours P=.75 for concurrent treatment compared with oxytocin, respectively. There was no significant difference for any other outcome.
CONCLUSION: : Concurrent vaginal dinoprostone and intravenous oxytocin for labor induction of term PROM did not expedite delivery or improve patient satisfaction.
CLINICAL TRIAL REGISTRATION: : Current Controlled Trials, www.controlled-trials.com, ISRCTN74376345
LEVEL OF EVIDENCE: : I.
METHODS: Parous women with favorable cervixes after amniotomy for labor induction were randomized to immediate titrated oxytocin or placebo intravenous infusion in a double-blind noninferiority trial. After 4 hours, study infusions were stopped, the women were assessed, and open-label oxytocin was started if required. Maternal satisfaction with the birth process was assessed with a 10-point visual numerical rating scale (lower score, greater satisfaction).
RESULTS: Vaginal delivery rates at 12 hours were 91 of 96 (94.8%) compared with 91 of 94 (96.8%) (relative risk 0.98, 95% confidence interval [CI] 0.92-1.04, P=.72), and maternal satisfaction on a visual numerical rating scale (median [interquartile range]) was 3 [3-4] compared with 3 [3-5], P=.36 for immediate compared with delayed arm, respectively). Cesarean delivery, maternal fever, postpartum hemorrhage, uterine hyperactivity, and adverse neonatal outcome rates were similar between arms. The immediate oxytocin arm had a shorter amniotomy-to-delivery interval of 5.3±3.1 compared with 6.9±2.9 hours (Poxytocin infusion was avoided by 35.6%.
CONCLUSIONS: Immediate or delayed oxytocin infusions are reasonable options after amniotomy for labor induction in parous women with favorable cervixes. The choice should take into account local resources and the woman's wish.
CLINICAL TRIAL REGISTRATION: ISRCTN Register, http://isrctn.org, ISRCTN51476259.
LEVEL OF EVIDENCE: I.
STUDY DESIGN: Participants were randomized to intravenous bolus injection of 100mcg carbetocin or 10IU oxytocin after cesarean delivery of the baby. The primary outcome is any additional uterotonic which may be administered by the blinded provider for perceived inadequate uterine tone with or without hemorrhage in the first 24hours after delivery. Secondary outcomes include operating time, perioperative blood loss, change in hemoglobin and hematocrit levels, blood transfusion and reoperation for postpartum hemorrhage.
RESULTS: Additional uterotonic rates were 107/276 (38.8%) vs. 155/271 (57.2%) [RR 0.68 95% CI 0.57-0.81 p<0.001; NNTb 6 95% CI 3.8-9.8], mean operating time 45.9±16.0 vs. 44.5±13.1minutes p=0.26, mean blood loss 458±258 vs. 446±281ml p=0.6, severe postpartum hemorrhage (≥1000ml) rates 15/276 (5.4%) vs. 10/271 (3.7%) p=0.33 and blood transfusion rates 6/276 (2.2%) vs. 10/271 (3.7%); p=0.30 for carbetocin and oxytocin arms respectively. There was only one case of re-operation (oxytocin arm). In the cases that needed additional uterotonic 98% (257/262) was started intraoperatively and in 89% (234/262) the only additional uterotonic administered was an oxytocin infusion over 6hours.
CONCLUSION: Fewer women in the carbetocin arm needed additional uterotonics but perioperative blood loss, severe postpartum hemorrhage, blood transfusion and operating time were not different.
METHODS: A systematic review of the literature was performed to identify randomized controlled trials that compared the use of carbetocin to oxytocin in the context of cesarean deliveries. Cost effectiveness analysis was then performed using secondary data from the perspective of a maternity unit within the Malaysian Ministry of Health, over a 24 h time period.
RESULTS: Seven randomized controlled trials with over 2000 patients comparing carbetocin with oxytocin during cesarean section were identified. The use of carbetocin in our center, which has an average of 3000 cesarean deliveries annually, would have prevented 108 episodes of PPH, 104 episodes of transfusion and reduced the need for additional uterotonics in 455 patients. The incremental cost effectiveness ratio of carbetocin for averting an episode of PPH was US$278.70.
CONCLUSION: Reduction in retreatment, staffing requirements, transfusion and potential medication errors mitigates the higher index cost of carbetocin. From a pharmacoeconomic perspective, in the context of cesarean section, carbetocin was cost effective as prophylaxis against PPH. Ultimately, the relative value placed on the outcomes above and the individual unit's resources would influence the choice of uterotonic.