Antenatal perineal training with a connected medical device improves perineal flexibility and is associated with reduced perineal trauma at first vaginal birth: a multicentre randomised controlled trial (PERIFLEX)

<b>Objective.</b> To determine whether antenatal perineal training with a connected balloon device improves perineal flexibility. <b>Design.</b> Multicentre, open-label, randomised controlled trial. <b>Setting.</b> Community-based midwifery practices in France. <b>Population.</b> Adult nulliparous women with a singleton cephalic pregnancy. <b>Methods.</b> Participants were randomised 1:1 to 90-day Emagina training, performed two to three times weekly, or standard antenatal care. Adherence and balloon diameter were recorded automatically. The day-90 maximum perineal diameter was analysed using a log-normal generalized-linear model adjusted on baseline diameter, with missing values imputed by the 10th percentile of the randomisation group. <b>Main outcome measures.</b> Maximum perineal diameter at day 90; perineal trauma, suturing, postpartum pelvic floor symptoms and device safety. <b>Results.</b> Eighty-seven women were randomised and analysed (41 Emagina, 46 control). Maximum perineal diameter at day 90 was 23.3% higher with Emagina than with standard care (multiplicative effect 1.23, 95% CI 1.17 - 1.30; P<0.0001), with a graded association across predefined adherence categories. Among 67 vaginal births, Emagina was associated with more intact or first-degree perinea (78.8% vs 55.9%; adjusted OR 6.24, 95% CI 1.73-28.49; P=0.009), fewer women requiring perineal suturing (54.5% vs 76.5%; adjusted OR 0.26, 95% CI 0.08-0.81; P=0.026), and fewer postnatal perineal-rehabilitation sessions (adjusted least-square mean difference -1.90, 95% CI - 3.31 to - 0.49; P=0.009). No serious adverse event was considered device- or procedure-related. <b>Conclusions.</b> Connected antenatal perineal training increased perineal flexibility and showed coherent exploratory reductions in early perineal morbidity, supporting definitive clinical trials.