Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study.

BACKGROUND: The first feasibility study of the OdonAssist inflatable device for use in clinically indicated assisted vaginal birth reported a success rate of 48% with no significant safety concerns. Additional studies exploring the device performance in other clinical settings are warranted before definitive conclusions can be drawn about its safety and efficacy in current practice. OBJECTIVE: This study aimed to investigate the safety and efficacy of the OdonAssist before conducting a randomized controlled trial. STUDY DESIGN: This was an open-label, nonrandomized study of 104 women with a clinically indicated assisted vaginal birth using the OdonAssist at the Besancon University Hospital, France. Data, including those of a nested cohort group of women who had an assisted vaginal birth using vacuum or spatulas because a trained OdonAssist device operator was not available at the time of delivery, were collected. The primary outcome measure was the proportion of successful assisted vaginal births using the OdonAssist. Neonatal outcome data were reviewed at days 1 and 28, and maternal outcomes were investigated up to day 90. RESULTS: Between December 2019 and May 2021, 2191 pregnant women were approached, and 83% (1636/1973) of them consented to participate in the study. Among them, 10.7% (176/1636) required an assisted vaginal birth owing to a vertex presentation at +1 and below. The OdonAssist was used in 59% of births (104/176), and 41.1% (72/176) of the participants were included in the nested cohort group. The rate of successful assisted vaginal births using the OdonAssist was 88.5% (92/104). No emergency cesarean deliveries were performed in the OdonAssist group. There were no serious adverse maternal or neonatal reactions related to the use of the device. The rate of third- and fourth-degree perineal tears with the OdonAssist was 3.8% (4/104). The maternal perception ratings of the birth experience with the OdonAssist (collected on days 1, 7, and 28 using a 15-point scale) were high. In addition, the operators reported a positive perception of the device, with ease of use across the different steps of the procedure. One single technique was used for all vertex fetal head positions. CONCLUSION: The OdonAssist is a safe and effective alternative to other current devices for assisted vaginal births. The high acceptance rate (83%) among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirm the feasibility of a future randomized controlled trial.

Conservative management versus systematic suture of isolated vaginal or first-degree perineal tears after delivery: A preliminary randomized efficacy trial.

BACKGROUND: The objective of this study was to assess the preliminary efficacy and safety of conservative management compared with systematic suture in isolated vaginal or first-degree perineal tears after birth. METHODS: We conducted a preliminary efficacy, open-label, randomized, controlled, and prospective trial. This study implemented Simon's 2-step plan (interim analysis and final analysis) to test the success rate of the digital compression strategy group. Primiparous women aged ≥18 years with isolated vaginal or first-degree perineal tears after spontaneous vaginal birth of a cephalic presenting term (≥37 weeks) neonate were randomly allocated to the conservative management (CM) group (digital compression if bleeding followed by suture if persistent bleeding) or a systematic suture (SS) group. The primary outcome was the success of the intervention 10 days after delivery, defined by pain as evaluated using a visual analog scale < 3, satisfactory healing defined by a REEDA score ≤ 2, and no bleeding or infection. Sexual well-being was assessed at 2 and 6 months postpartum. RESULTS: Among 861/2209 eligible women, 143 consenting women with a superficial perineal tear were randomized: 72 in the systematic suture group and 71 in the conservative management group. Success rate was 87.8% (90% CI [70.5-93.54]) (42/55) in the systematic suture group vs 90% (90% CI [78.3-93.8]) (53/61) in the conservative management group. The REEDA score was significantly higher in the systematic suture group (1.4 vs 0.9; P = 0.036). Perineal pain was significantly higher at day 1 in the systematic suture group (2.38 vs 1.69; P = 0.034). For the Female Sexual Functional Index score, no significant difference was found between the two groups at inclusion or at 2 and 6 months postpartum. CONCLUSIONS: Conservative management of superficial perineal tears shows an efficacy rate ≥90%. Women in the conservative management group had less pain at the 1st day follow-up and lower REEDA scores at the 10th day follow-up.

Mode of delivery of twin pregnancies with the first twin in breech position after the introduction of a policy of planned caesarean delivery for nulliparous women.

INTRODUCTION: To evaluate the impact of the mode of delivery of twin pregnancies with the first twin in breech position for all parities combined after introduction of a policy of planned caesarean section in 38 weeks' gestation in nulliparas. MATERIAL AND METHODS: A retrospective study of the mode of delivery of twin pregnancies with the first twin in breech position was conducted from January 2007 to December 2015 after the implementation of a planned caesarean section in 38 weeks' gestation in nulliparas. Maternal and neonatal outcomes were compared according to the decision of attempted vaginal or planned caesarean delivery. RESULTS: Among the 134 women included, an attempted vaginal delivery was decided for 30.6% women (n = 41), with 95% (n = 39) who delivered vaginally and 5% (n = 2) by caesarean section during labour. Among the 69.4% women (n = 93) with a planned caesarean section, 64.5% (n = 60) and 11.8% (n = 11) delivered by caesarean before labour and during labour, respectively, and 23.7% (n = 22) delivered vaginally. The overall vaginal delivery rate was 45.5%, and the overall rate of caesarean section was 54.5% for all parities combined. In nulliparous women, the rate of caesarean section during labour was 33%. There were no significant differences in maternal mortality or morbidity between the two groups. CONCLUSION: A selective policy of attempted vaginal delivery based on parity for twin pregnancies with the first twin in breech position can lead to a reduction in the overall rate of caesarean section in this population.