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Master Thesis

Rotation manuelle versus expectative en cas de variétés postérieures persistantes pour diminuer les accouchements opératoires. Etude MARO-POP : étude multicentrique en simple aveugle randomisée contrôlée

Abstract : Background. The frequency of persistent occiput posterior (POP) presentations is 10 to 20%.These POP presentations are associated with higher rates of operative delivery and associated maternal and neonatal complications. Actually, there is no standardized management for POP. Numerous observational studies have shown that using systematic manual rotation (MR) versus expectant in case of POP is associated with a decrease in operative delivery rates. However, selection bias and residual confounding cannot be ruled out in this observational setting. Risks associated to MR are thus lower than potential benefit associated to prevention of operative delivery. We therefore propose to conduct a multicenter randomized controlled trial to test the superiority of systematic MR over expectative management to decrease operative delivery rate of POP. Methods. Eligible participants with a suspicion of POP will have a transabdominal ultrasound to confirm position. After confirming a POP, participants with written consent will be randomized into an experimental group (MR) or a control group (sham procedure).Based on a background risk of operative delivery of 40%, then for a reduction to 30% (α = 0.05, 1-ß = 0.90, and a bilateral test) the study requires 326 women per group. The primary outcome will be operative delivery. Secondary outcomes will be in particular maternal and neonatal morbidities. Analysis will be by intention-to-treat. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. Discussion. Given that the efficacy of MR has not been proven with a high level of evidence, the practice of this technique is not systematically recommended by scholarly societies and is, therefore, rarely performed by obstetric gynecologists. If our hypothesis regarding the superiority of MR is confirmed, our study will help change delivery practices in cases of POP.
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Submitted on : Thursday, December 19, 2019 - 6:18:25 PM
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Lise-Marie Dorcier. Rotation manuelle versus expectative en cas de variétés postérieures persistantes pour diminuer les accouchements opératoires. Etude MARO-POP : étude multicentrique en simple aveugle randomisée contrôlée. Sciences du Vivant [q-bio]. 2019. ⟨dumas-02420351⟩

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