背景：经典的中期早产胎膜早破（PPROM）定义为妊娠28周（WG）前胎膜破裂伴羊水过少/过少；它使大约0.4-0.7％的妊娠复杂化，并与非常高的新生儿死亡率和发病率相关。抗生素在防止细菌生长方面取得的成功有限，绒毛膜羊膜炎和胎儿炎症。重复羊膜输注不起作用，因为在干预后立即失去液体。在患有经典PPROM的患者中，通过经腹系统或导管的连续羊膜输注通过冲洗羊膜腔中的细菌和炎症成分显示出希望，更换羊水，从而延长PPROM至分娩间隔。
目的：这项多中心试验旨在测试连续羊膜输注对新生儿生存的影响，而没有典型的主要发病率。比如严重的支气管肺发育不良,脑室内出血,分娩后一年的囊性脑室周围白质软化和坏死性小肠结肠炎。
方法：我们计划进行一项双臂平行设计的随机多中心试验。随机化将在22/0和26/0SSW之间。对照组：20/0至26/0WG之间的PPROM患者，将根据德国妇产科学会（标准PPROM治疗）的指南接受抗生素和皮质类固醇（来自22/0SSW）治疗。在介入组中，标准的PPROM治疗将补充羊膜冲洗法，通过羊膜内导管进行羊膜冲洗溶液的羊膜输注（最高100mL/h，2400mL/天)。
方法：该研究将包括68例20/0至26/0WG之间的经典PPROM患者。
背景：ClinicalTrials.govID：NCT04696003。
背景：DRKS00024503，2021年1月。
BACKGROUND: The classic mid-trimester preterm premature rupture of membranes (PPROM) is defined as a rupture of the fetal membranes prior to 28 weeks of gestation (WG) with oligo/anhydramnion; it 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 does not work because fluid is lost immediately after the intervention. The continuous amnioinfusion through the transabdominal port system or catheter in patients with classic PPROM shows promise by flushing out the bacteria and inflammatory components from the amniotic cavity, replacing amniotic fluid and thus prolonging the PPROM-to-delivery interval.
OBJECTIVE: This multicenter trial aims to test the effect of continuous amnioinfusion on the neonatal survival without the typical major morbidities, such as severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis one year after the delivery.
METHODS: We plan to conduct a randomized multicenter trial with a two-arm parallel design. Randomization will be between 22/0 and 26/0 SSW. The control group: PPROM patients between 20/0 and 26/0 WG who will be treated with antibiotics and corticosteroids (from 22/0 SSW) in accordance with the guidelines of German Society of Obstetrics and Gynecology (standard PPROM therapy). In the interventional group, the standard PPROM therapy will be complemented with the Amnion Flush Method, with the amnioinfusion of Amnion Flush Solution through the intra-amnial catheter (up to 100 mL/h, 2400 mL/day).
METHODS: The study will include 68 patients with classic PPROM between 20/0 and 26/0 WG.
BACKGROUND: ClinicalTrials.gov ID: NCT04696003.
BACKGROUND: DRKS00024503, January 2021.
