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A pilot randomized controlled trial of complete bed rest vs activity restriction after preterm premature rupture of the membranes

European Journal of Obstetrics & Gynecology and Reproductive Biology Aug 03, 2019

Martins I, et al. - Via performing a pilot unblinded randomized controlled trial, researchers investigated how bed-rest influences maternal and neonatal outcomes in pregnancies complicated by preterm premature rupture of the membranes (PPROM), enabling proper sample size calculation for a powered randomized controlled trial (RCT). Thirty-two women with singleton pregnancies complicated by PPROM were allocated 1:1 ratio (complete bed rest vs activity restriction groups) at 24 + 0-33 + 6 weeks. Outcomes revealed no increased latency to delivery and no improvement in maternal or neonatal morbidity in correlation with bed rest in the setting of PPROM at 24 + 0-33 + 6 weeks. For a powered RCT, a sample size of 2,052 participants was assessed, considering latency as the primary outcome.
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