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Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79–1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P =.06). The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Persistent occiput posterior and occiput transverse positions are the most common malpositions of the fetal head during labor and are associated with prolonged second stage of labor, cesarean deliveries, instrumental deliveries, severe perineal tears, postpartum hemorrhage, and chorioamnionitis. Manual rotation is one of several strategies described to deal with these malpositions.Objective: This study aimed to determine if the trial of prophylactic manual rotation at the early second stage of labor is associated with a decrease in operative deliveries (instrumental and/or cesarean deliveries).Study Design: We conducted a multicenter, open-label, randomized controlled trial in 4 French hospitals. Women with singleton term pregnancy and occiput posterior or occiput transverse position confirmed by ultrasound at the early second stage of labor and with epidural analgesia were eligible. Women were randomly assigned (1:1) to either undergo a trial of prophylactic manual rotation of occiput posterior or occiput transverse position (intervention group) or no trial of prophylactic manual rotation (standard group). The primary outcome was operative delivery (instrumental and/or cesarean deliveries). The secondary outcomes were length of the second stage of labor, maternal complications (postpartum hemorrhage, operative complications during cesarean delivery, episiotomy and perineal tears), and neonatal complications (Apgar score of <5 at 10 minutes, arterial umbilical pH of <7.10, neonatal injuries, neonatal intensive care unit admission). The main analysis was focused on intention-to-treat analysis.Results: From December 2015 to December 2019, a total of 257 women (mean age, 30.4 years; mean gestational age, 40.1 weeks) were randomized: 126 were assigned to the intervention group and 131 were assigned to the standard group. Operative delivery was significantly less frequent in the intervention group compared with the standard group (29.4% [37 of 126] vs 41.2% [54 of 131]; P=.047; differential [intervention-standard] [95% confidence interval] = -11.8 [-15.7 to -7.9]; unadjusted odds ratio [95% confidence interval] = 0.593 [0.353-0.995]). Women in the intervention group were more likely to have a significantly shorter second stage of labor.Conclusion: Trial of prophylactic manual rotation of occiput posterior or occiput transverse positions during the early second stage of labor was statistically associated with a reduced risk of operative delivery. This maneuver could be a safe strategy to prevention operative delivery. [ABSTRACT FROM AUTHOR]

Background: Uncertain fetal head engagement represents 4% of obstetrical situations associated with an increased risk of postpartum hemorrhage, notably in cases of cesarean delivery and increased neonatal impairment owing to failed vaginal instrumental delivery. In this obstetrical condition, cesarean delivery is recommended, but vaginal delivery is possible in two-thirds of the cases. During the second stage of labor, the descent of the fetal head can be assessed by sonography, particularly by measuring the angle of progression.Objective: To evaluate, after a prolonged second stage of labor, the impact of measuring the angle of progression in addition to a digital examination on cesarean delivery rates when fetal head engagement remains uncertain.Study Design: This open multicenter randomized pragmatic trial included women at term with a singleton cephalic fetus in a clinical occiput anterior position after a prolonged 2-hour second stage of labor with uncertain fetal head engagement. After inclusion in the study, an independent investigator performed ultrasound systematically to confirm the occiput anterior position and measured the angle of progression at the climax of Valsalva pushing. This operator did not participate in labor management. In the study group but not in the control group, the angle of progression was communicated to the obstetrician in charge of labor management. Obstetricians were encouraged to attempt vaginal birth if the angle of progression was >120°. The primary outcome was the cesarean delivery rate. Secondary outcomes were operative delivery rate (cesarean delivery and operative vaginal delivery), maternal complications (third and fourth-degree perineal tears, failed vaginal instrumental delivery, postpartum hemorrhage, hysterectomy), and neonatal outcomes (Apgar score <5 at 10 minutes, umbilical arterial pH <7.10, neonatal wounds, neonatal intensive care unit admission).Results: A total of 45 women were included in the study. Occiput anterior position was confirmed in 33 women: 16 in the study group and 17 in the control group. Women's characteristics at baseline were similar between the groups. The median (range) angles of progression were similar: 138.4° (15) and 140.3° (16.9) in the study and control group, respectively. Cesarean delivery rates were 12.5% in the study group and 41.1% in the control group (P=.06). Secondary outcomes were similar between the 2 groups. No failed vaginal instrumental delivery was reported.Conclusion: Measurement of the angle of progression in addition to digital examination when fetal head engagement remained uncertain showed promising results in decreasing cesarean delivery rates. A larger multicenter randomized controlled trial is needed to confirm these results. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study was to evaluate the intra- and interobserver agreement among obstetric experts in court regarding the retrospective review of abnormal fetal heart rate tracings and obstetrical management of patients with abnormal fetal heart rate during labor.Study Design: A total of 22 French obstetric experts in court reviewed 30 cases of term deliveries of singleton pregnancies diagnosed with at least 1 hour of abnormal fetal heart rate, including 10 cases with adverse neonatal outcome. The experts reviewed all cases twice within a 3-month interval, with the first review being blinded to neonatal outcome. For each case reviewed, the experts were provided with the obstetric data and copies of the complete fetal heart rate recording and the partogram. The experts were asked to classify the abnormal fetal heart rate tracing and to express whether they agreed with the obstetrical management performed. When they disagreed, the experts were asked whether they concluded that an error had been made and whether they considered the obstetrical management as the cause of cerebral palsy in children if any.Results: Compared with blinded review, the experts were significantly more likely to agree with the obstetric management performed (P < .001) and with the mode of delivery (P < .001) when informed about the neonatal outcome and were less likely to conclude that an error had been made (P < .001) or to establish a link with potential cerebral palsy (P = .003). The experts' intraobserver agreement for the review of abnormal fetal heart rate tracing and obstetrical management were both mediocre (kappa = 0.46-0.51 and kappa = 0.48-0.53, respectively). The interobserver agreement for the review of abnormal fetal heart rate tracing was low and was not improved by knowledge of the neonatal outcome (kappa = 0.11-0.18). The interobserver agreement for the interpretation of obstetrical management was also low (kappa = 0.08-0.19) but appeared to be improved by knowledge of the neonatal outcome (kappa = 0.15-0.32).Conclusion: The intra- and interobserver agreement among obstetric experts in court for the review of abnormal fetal heart rate tracing and the appropriateness of obstetrical care is poor, suggesting a lack of objectivity of obstetrical expertise as currently performed in court. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery in women with a twin pregnancy and short cervix. Study Design: This open-label, multicenter, randomized controlled trial included women with a twin pregnancy between 24+0 and 31+6 weeks of gestation who were asymptomatic and had a cervical length of 25 mm or less measured by routine transvaginal ultrasound. Women were randomized to receive (or not) 500 mg of intramuscular 17P, repeated twice weekly until 36 weeks or preterm delivery. The primary outcome was time from randomization to delivery. Analysis was performed according to the intent-to-treat principle. Results: The 17P and control groups did not differ significantly for median [interquartile range] time to delivery: 45 (26–62) and 51 (36–66) days, respectively. However, treatment with 17P was associated with a significant increase in the rate of preterm delivery before 32 weeks. Conclusion: Twice-weekly injections of 17P did not prolong pregnancy significantly in asymptomatic women with a twin pregnancy and short cervix. [ABSTRACT FROM AUTHOR]