Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion (AmnionFlush)
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intracranial Hemorrhages
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring PPROM, Amnion Flush Solution, outcome, amnioinfusion
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy (from 22/0 to 26/0 weeks of gestation)
- Evidence of PPROM from clinical and instrumental investigations
- Oligo/anhydramnion (< 2 cm deepest amniotic fluid pocket)
Exclusion Criteria:
- fetal death
- placental abnormalities
- labor
- evidence of major structural or chromosomal abnormalities
- signs of chorioamnionitis (maternal fever > 38° C and one or more of the following criteria: uterine tenderness, malodorous vag-inal discharge, maternal leukocytosis > 15000 cells/mm3, maternal tachycardia > 100 beats/min, and fetal heart rate > 160 bpm).
Sites / Locations
- Martin Luther University, Clinic of Obstetrics and Prenatal Medicine
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
control
Amnion Flush group (continuous amnioinfusion)
The patients with classic PPROM between 22/0-26/0 weeks' gestation with oligo/anhydramnion with standard conservative treatment (7 days Amoxicillin/Clarithromycin therapy or 7 days Amoxicillin and once Azithromycin 1 g per os, and corticosteroids like Celestan®, Essex Pharma, Munich, Germany) as RDS prophylaxis will represent the control group (DGGG Guideline AWMF 015-025, February 2019, Version 1.0). The diagnosis of the PPROM must be not early than 20/0 weeks' gestation.
In the "Amnion Flush" group additionally to the standard treatment the amniotic cavity will be punctured with a 18 gauge needle under ultrasound control. The intra-amniotic catheter (0.65 mm Diameter, CE 0481, PakuMed GmbH, Essen, Germany) will be placed under local anesthesia with Xylocaine 1% 10 ml. Amnion Flush Solution (CE 0483, Serumwerk AG Bernburg, Germany) will be carried out with an infusion rate of 100 ml/h (2400 ml/d) under periodic ultrasound using the standard i.v. pump. The deepest pool of amniotic fluid should be stabilized by about 4 cm. The ultrasound control will be performed daily. Induction of the labour or c-section at 34/0 week of gestation or earlier if indicated.