The value of amniopatch in pregnancies associated with spontaneous preterm premature rupture of fetal membranes: a randomized controlled trial

Abstract

<b>Objective:</b> To evaluate the efficacy and safety of amniopatch in pregnancies associated with spontaneous preterm premature rupture of fetal membranes (PPROM).<b>Methods:</b> A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into two groups. Group I in which amniopatch was done in addition to the routine management. Group II was treated with routine management including antibiotics and corticosteroids.<b>Results:</b> Amniopatch was successful in complete sealing of the membrane defect in 6/50 (12%) of women while none the control group have undergone similar sealing (<i>p</i> = .0144, RR = 0.88). Women in the amniopatch group showed a significant increase of AFI compared to controls (12 versus 0, <i>p</i> = .0001, RR = 0.56).<b>Conclusion:</b> The amniopatch procedure is a successful technique that safely enhances sealing of fetal membranes and restore the AFI.<b>Clinical trial registration</b>: NCT03473210<b>Synopsis</b>The amniopatch procedure is a successful technique that could be done safely to enhance sealing the fetal membranes and restoring the AFI after PPROM.