This study will answer the question if (repeated) abdominal amnioninfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is perinatal mortality.
Secondary outcome
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.
Background summary
Babies born after midtrimester preterm prelabour rupture of membranes (PPROM)
are prone to neonatal pulmonary hypoplasia. Perinatal mortality after this
complication is high. Oligohydramnios in the midtrimester following PPROM is
considered to cause a delay in lung development. Repeated transabdominal
amnioninfusion with the objective to alleviate oligohydramnios might prevent
this complication and might improve neonatal outcome in general.
Study objective
This study will answer the question if (repeated) abdominal amnioninfusion
after midtrimester PPROM with associated oligohydramnios improves perinatal
survival and prevents pulmonary hypoplasia and other neonatal morbidities.
Moreover, it will assess the risks associated with this procedure.
Study design
Randomized controlled trial (multicentre).
Intervention
Random allocation to (repeated) abdominal amnioninfusion (intervention) or
expectant management (control).
Study burden and risks
Women with PPROM before 24 weeks with oligohydramnion participating in the
trial and being allocated to the intervention group will undergo weekly
amnioninfusion in a tertiary centre. They will undergo twice weekly ultrasound
assessment, and if oligohydramnion re-occurs or persists, weekly
transabdominal amnion infusion. This procedure consists of infusion of a
sterile solution through a large bore needle inserted through the abdominal
wall under ultrasound guidance. This procedure is not different from
amniocentesis except fluid is instilled rather than removed. Risks described by
this procedure are premature labour and delivery, fetal loss, fetal trauma,
infection, uterine perforation, placental abruption. Patients allocated to the
conservative group will be managed according to the strategy applied in the
current practice. Patients with midtrimester PPROM are usually hospitalized
after 24 weeks in a tertiary center. All patients will undergo weekly
assessment of ultrasound parameters used in prediction of pulmonary hypoplasia.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36645.018.11 |
| OMON | NL-OMON26522 |