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.
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。