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

International audienceBackground: The objective of this study was to assess the preliminary efficacy and safety of conservative management compared with systematic suture in isolated vaginal or firstdegree 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 presentating 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 two and six months postpartum. Results: Among 861/2,209 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 versus 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 versus 0.9; p=0.036). Perineal pain was significantly higher at day one 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. Conclusion: Conservative management of superficial perineal tears shows an efficacy rate ≥ 90%. Women in the conservative management group had less pain at the first-day follow-up and lower REEDA scores at the 10 th-day follow-up