Treatment of classic mid-trimester preterm premature rupture of membranes (PPROM) with oligo/ anhydramnion between 22 – 26 weeks’ gestation by means of continuous amnioinfusion: a randomized multicentric prospective controlled TRIAL

Abstract

Background: The classic mid-trimester preterm premature rupture of membranes (PPROM), is defined as rupture of fetal membranes prior to 28 weeks’ gestation (WG) with oligo/ anhydramnion, complicates approximately 0.4-0.7% of all pregnancies and is associated with very high neonatal mortality and morbidity.Antibiotics have limited success to prevent bacterial growth, chorioamnionitis and fetal inflammation. The repetitive amnioinfusion doesn’t work because of immediately fluid lost after the intervention. The continuous amnioinfusion through the transabdomianal port system or catheter in patients with classic PPROM shows promise by flush out of bacteria and inflammatory components from the amniotic cavity, replacing amniotic fluid and thus prolonging PPROM-to-delivery interval.Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal survival without the typical major morbidities, like severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis one year after the delivery.Methods/Design: randomized multicenter trial; two-arm parallel design. Control group: PPROM patients between 22/0 (20/0) -26/0 WG treated with antibiotics and corticosteroids in accordance to guidelines of German Society of Obstetrics and Gynecology (standard PPROM therapy). In the interventional group the standard PPROM therapy will be complemented by “Amnion Flush Method” with the amnioinfusion of artificial amniotic fluid (up to 100 ml/h, 2400 ml/day).Subjects: 68 patients with classic PPROM between 22/0 (20/0)-26/0 WG.TRIAL-registration: ClinicalTrials.gov ID: NCT04696003 and German Clinical Trials Register: DRKS00024503, January 2021.The trial is approved by the Ethic committee of the Martin-Luther University Halle-Wittenberg (2020-185, January 25, 2021).