Perinatal mortality. The number of stillbirths and deaths in the first week of life
Conditions
Interventions
Random allocation to (repeated) abdominal amnioninfusion (intervention) or
expectant management (control).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All women with a singleton pregnancy who were first diagnosed between 16 and 24 weeks gestational age with oligohydramnios secondary to PPROM, at least 72 hours after PPROM was diagnosed, but no longer than 21 days after the diagnosis of oligohydramnion, are eligible for the trial.
Exclusion criteria
Exclusion criteria: Women having signs of premature uterine contractions, intra uterine infection, or women 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is perinatal mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 I, periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, 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. | — |
Countries
Netherlands
Outcome results
None listed