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17-Alpha hydroxyprogesterone in Multiple pregnancies to Prevent Handicapped InfAnts

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40512715
Enrollment
700
Registered
2007-01-04
Start date
2006-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple pregnancy Pregnancy and Childbirth Multiple pregnancy

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)
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026