Status:
UNKNOWN
Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion
Lead Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Conditions:
Bronchopulmonary Dysplasia
Necrotizing Enterocolitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Objective: Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of all pregnancies...
Detailed Description
Objective: Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of all pregnancie...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04696003
Start Date
January 1 2021
End Date
May 30 2025
Last Update
January 12 2021
Active Locations (1)
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1
Martin Luther University, Clinic of Obstetrics and Prenatal Medicine
Halle, Saxony-Anhalt, Germany, 06120