妊娠22至26周时，采用持续羊膜腔灌注治疗伴有羊水过少/羊水过少的典型孕中期胎膜早破（PPROM）：一项随机多中心前瞻性对照试验方案及文献综述
Treatment of Classic Mid-Trimester Preterm Premature Rupture of Membranes (PPROM) with Oligo/Anhydramnion between 22 and 26 Weeks of Gestation by Means of Continuous Amnioinfusion: Protocol of a Randomized Multicentric Prospective Controlled TRIAL and Review of the Literature.
作者信息
Tchirikov Michael, Haiduk Christian, Tchirikov Miriam, Riemer Marcus, Bergner Michael, Li Weijing, Henschen Stephan, Entezami Michael, Wienke Andreas, Seliger Gregor
机构信息
Clinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, 06120 Halle (Saale), Germany.
Center of Clinical Studies, Martin Luther University Halle-Wittenberg, 06108 Halle (Saale), Germany.
出版信息
Life (Basel). 2022 Aug 30;12(9):1351. doi: 10.3390/life12091351.
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.
STUDY DESIGN
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).
SUBJECTS
The study will include 68 patients with classic PPROM between 20/0 and 26/0 WG.
TRIAL-REGISTRATION: ClinicalTrials.gov ID: NCT04696003.
GERMAN CLINICAL TRIALS REGISTER
DRKS00024503, January 2021.
背景
经典的孕中期胎膜早破（PPROM）定义为妊娠28周前胎膜破裂并伴有羊水过少/无羊水；它在所有妊娠中约占0.4 - 0.7%，并与极高的新生儿死亡率和发病率相关。抗生素在预防细菌生长、绒毛膜羊膜炎和胎儿炎症方面效果有限。重复羊膜腔灌注不起作用，因为灌注后液体立即流失。对于经典PPROM患者，通过经腹端口系统或导管进行持续羊膜腔灌注，通过冲洗羊膜腔内的细菌和炎症成分、补充羊水，从而延长PPROM至分娩的间隔时间，显示出一定前景。
目的
这项多中心试验旨在测试持续羊膜腔灌注对新生儿生存的影响，即分娩后一年无典型的严重并发症，如重度支气管肺发育不良、脑室内出血、脑室周围白质软化症和坏死性小肠结肠炎。
研究设计
我们计划进行一项双臂平行设计的随机多中心试验。随机分组将在妊娠22⁺⁰周和26⁺⁰周之间进行。对照组：妊娠20⁺⁰周至26⁺⁰周的PPROM患者，将根据德国妇产科学会的指南接受抗生素和皮质类固醇治疗（从妊娠22⁺⁰周开始）（标准PPROM治疗）。干预组在标准PPROM治疗的基础上，采用羊膜冲洗法，通过羊膜内导管灌注羊膜冲洗液（最高100 mL/h，2400 mL/天）。
研究对象
该研究将纳入68例妊娠20⁺⁰周至26⁺⁰周的经典PPROM患者。
试验注册
ClinicalTrials.gov标识符：NCT04696003。
德国临床试验注册
DRKS00024503，2021年1月。
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