Multiple pregnancy Pregnancy and Childbirth Multiple pregnancy
Conditions
Interventions
Participants will receive weekly intramuscular injections of 17OHPC or placebo, starting at a gestational age between 16 and 20 weeks and continuing until 36 weeks. Cervical length will be measured at
Sponsors
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a multiple pregnancy 2. Gestational age between 15 and 19 weeks 3. Aged 18 and older
Exclusion criteria
Exclusion criteria: 1. Major congenital anomaly of (one of) the fetuses 2. Death of (one of) the fetuses 3. Early signs of Twin-to-Twin Transfusion Syndrome 4. Primary cerclage 5. Previous preterm birth less than 34 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be composite neonatal morbidity, containing severe Respiratory Distress Syndrome (RDS), BronchoPulmonal Dysplasia (BPD), intraventricular haemorrhage stage IIB or worse, Necrotising EnteroColitis (NEC), proven sepsis and death before discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: 1. Time to delivery 2. Preterm birth rate before 32 and 37 weeks 3. Days of admission in neonatal intensive care unit 4. Maternal morbidity 5. Maternal admission days for preterm labour 6. Costs | — |
Countries
Netherlands
Outcome results
None listed