Assessment of Amnioninfusion for improving perinatal outcomes after midtrimester preterm prelabour rupture of membranes.

Recruiting

Conditions: Perinatal mortality. The number of stillbirths and deaths in the first week of life.Perinatale sterfte. Het aantal doodgeborenen en doden in de eerste levensweek.Keywords: Midtrimester preterm prelabour rupture ofmembranes. Perinatal outcome. Oligohydramnios. Amnioinfusion.

Registration Number: NL-OMON26522

Lead Sponsor: Academical Medical Centre Amsterdam

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

Women with a singleton pregnancy complicated by oligohydramnios secondary to PPROM at a gestational age between 16 and 24 weeks, minimum 72 hours after PPROM was diagnosed, but no longer than 21 days after this diagnosis.

Exclusion Criteria

Women having signs of premature uterine contractions, intra uterine infection, or wornen having a maternal disease (hypertension, HELLP syndrome, preeclampsia or other) as reason for delivery. Placental or major structural fetal anomalies. Signs of cervical incompetence. Women whose child has signs of fetal distress (abnormal biophysical profile).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perinatal mortality. The number of stillbirths and deaths in the first week of life.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are: Lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia. survival till discharge from NICU, neonatal mortality. chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC) more tha stage l, periventricular leucomalacia (PVL) more than grade l, severe intraventricular hemorrhage (lVH) more than grade ll, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, succesfull amnioninfusion, placental abruption, cord prolaps, chorioamnionitis, fetal trauma due to puncture.