Search

Background Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). Methods and findings This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, [greater than or equal to]41+0 and [less than or equal to]42+0 weeks' gestation, a Bishop score Conclusions In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. Trial registration ClinicalTrials.gov NCT02907060., Author(s): Caroline Diguisto 1,2,3,*, Amélie Le Gouge 4, Chloé Arthuis 5, Norbert Winer 5, Olivier Parant 6, Christophe Poncelet 7,8, Celine Chauleur 9,10, Jacob Hannigsberg 11, Guillaume Ducarme 12, Denis [...]

Importance: Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes., Objective: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes., Design, Settings, and Participants: The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation., Interventions: Women who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations., Main Outcomes and Measures: The primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval., Results: Among the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, -∞ to 10.5%; P=.19)., Conclusion and Relevance: This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment., Trial Registration: clinicaltrials.gov Identifier: NCT01731431.

The primary cause of uterine scars is a previous cesarean. In women with a previous cesarean, the risks of maternal complications are rare and similar after a trial of labor after cesarean (TOLAC) and after an elective repeat cesarean delivery (ERCD), but the risk of uterine rupture is higher with TOLAC (level of evidence [LE]2). Maternal morbidity in women with previous cesareans is higher when TOLAC fails than when it leads to successful vaginal delivery (LE2). Although maternal morbidity increases progressively with the number of ERCD, maternal morbidity of TOLAC decreases with the number of successful previous TOLAC (LE2). The risk-benefit ratio considering the risks of short- and long-term maternal complications is favorable to TOLAC in most cases (LE3). Globally, neonatal complications are rare regardless of the mode of delivery for women with previous cesareans. The risks of fetal, perinatal, and neonatal mortality during TOLAC are low. Nonetheless, these risks are significantly higher than those associated with ERCD (LE2). The risks of mask ventilation, intubation for meconium-stained amniotic fluid, and neonatal sepsis all increase in TOLAC (LE2). The risk of transient respiratory distress increases in ERCD (LE2). To reduce this risk, and except in particular situations, ERCD must not be performed before 39 weeks (grade B). TOLAC is possible for women with a previous cesarean before 37 weeks, with 2 previous cesareans, with a uterine malformation, a low vertical incision or an unknown incision, with a myomectomy, postpartum fever, an interval of less than 6 months between the last cesarean delivery and the conception of the following pregnancy, if the obstetric conditions are favorable (professional consensus). ERCD is recommended in women with a scar in the uterine body (grade B) and a history of 3 or more cesareans (professional consensus). Ultrasound assessment of the risk of uterine rupture in women with uterine scars has not been shown to have any clinical utility and is therefore not recommended during pregnancy to help decide the mode of delivery (professional consensus). Use of X-ray pelvimetry to decide about TOLAC is associated with an increase in the repeat cesarean rate without any reduction in the rate of uterine rupture (LE2). It is unnecessary for deciding mode of delivery and for managing labor during TOLAC (grade C). TOLAC should be encouraged for women with a previous vaginal delivery either before or after the cesarean, a favorable Bishop score or spontaneous labor, and for preterm births (grade C). For women with a fetus with an estimated weight of more than 4500 g, especially in the absence of a previous vaginal delivery and those with supermorbid obesity (BMI>50), ERCD must be planned from the outset (grade C). For all of the other clinical situations envisioned (maternal age>35 years, diabetes, morbid obesity, prolonged pregnancy, breech presentation and twin pregnancy), TOLAC is possible but the available data do not allow specific guidelines about the choice of mode of delivery, in view of the low levels of proof (grade C). The decision about planned mode of delivery must be shared by the patient and her physician and made by the 8th month, taking into account the individual risk factors for TOLAC failure and uterine rupture (professional consensus). TOLAC is the preferred choice for women who do not have several risk factors (professional consensus). The availability onsite of an obstetrician and anesthetist must be pointed out to the patient. If the woman continues to prefer a repeat cesarean after adequate information and time to think about it, her preference should be honored (professional consensus). Labor should be induced in woman with a previous cesarean only for medical indications (professional consensus). Induction of labor increases the risk of uterine rupture, which can be estimated at 1% if oxytocin is used and 2% with vaginal prostaglandins (LE2). Mechanical methods of induction have not been studied sufficiently. Misoprostol appears to increase the risk of uterine rupture strongly (LE4). Based on the information now available, its use is not recommended (professional consensus). Routine use of internal tocodynamometry does not prevent uterine rupture (professional consensus). The increased risk of uterine rupture associated with oxytocin use is dose-dependent (LE3). In the active phase, it is recommended that the total duration of failure to progress should not exceed 3h; at that point, a cesarean should be performed (professional consensus). Epidural analgesia must be encouraged. The simple existence of a uterine scar is not an indication for a routine manual uterine examination after VBAC (grade C)., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Routine use of a partograph is associated with a reduction in the use of forceps, but is not associated with a reduction in the use of vacuum extraction (Level A). Early artificial rupture of the membranes, associated with oxytocin perfusion, does not reduce the number of operative vaginal deliveries (Level A), but does increase the rate of fetal heart rate abnormalities (Level B). Early correction of lack of progress in dilatation by oxytocin perfusion can reduce the number of operative vaginal deliveries (Level B). The use of low-concentration epidural infusions of bupivacaine potentiated by morphinomimetics reduces the number of operative interventions compared with larger doses (Level A). Placement of an epidural before 3-cm dilatation does not increase the number of operative vaginal deliveries (Level A). Posterior positions of the fetus result in more operative vaginal deliveries (Level B). Manual rotation of the fetus from a posterior position to an anterior position may reduce the number of operative deliveries (Level C). Walking during labour is not associated with a reduction in the number of operative vaginal deliveries (Level A). Continuous support of the parturient by a midwife or partner/family member during labour reduces the number of operative vaginal deliveries (Level A). Under epidural analgesia, delayed pushing (2h after full dilatation) reduces the number of difficult operative vaginal deliveries (Level A). Ultrasound is recommended if there is any clinical doubt about the presentation of the fetus (Level B). The available scientific data are insufficient to contra-indicate attempted midoperative delivery (professional consensus). The duration of the operative intervention is slightly shorter with forceps than with a vacuum extractor (Level C). Nonetheless, the urgency of operative delivery is not a reason to choose one instrument over another (professional consensus). The cup-shaped vacuum extractor seems to be the instrument of choice for operative deliveries of fetuses in a cephalic transverse position, and may also be preferred for fetuses in a posterior position (professional consensus). Vacuum extraction deliveries fail more often than forceps deliveries (Level B). Overall, immediate maternal complications are more common for forceps deliveries than vacuum extraction deliveries (Level B). Compared with forceps, operative vaginal delivery using a vacuum extractor appears to reduce the number of episiotomies (Level B), first- and second-degree perineal lesions, and damage to the anal sphincter (Level B). Among the long-term complications, the rate of urinary incontinence is similar following forceps, vacuum extraction and spontaneous vaginal deliveries (Level B). Anal incontinence is more common following forceps delivery (Level B). Persistent anal incontinence has a similar prevalence regardless of the mode of delivery (caesarean or vaginal, instrumental or non-instrumental), suggesting the involvement of other factors (Level B). Rates of immediate neonatal mortality and morbidity are similar for forceps and vacuum extraction deliveries (Level B). It appears that difficult instrumental delivery may lead to psychological sequelae that may result in a decision not to have more children (Level C). The rates of neonatal convulsions, intracranial haemorrhage and jaundice do not differ between forceps and vacuum extraction deliveries (Levels B and C). Rapid sequence induction with a Sellick manoeuvre (pressure to the cricoid cartilage) and tracheal intubation with a balloon catheter is recommended for any general anaesthesia (Level B). Training must ensure that obstetricians can identify indications and contra-indications, choose the appropriate instrument, use the instruments correctly, and know the principles of quality control applied to operative vaginal delivery. Nowadays, traditional training can be accompanied by simulations. Training should be individualized and extended for some students., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)