FindTrial
Sign In

Single Injection 17-hydroxyprogesterone caproate in Preterm labour: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22145023
Enrollment
256
Registered
2007-02-02
Start date
2007-02-15
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

Preterm labour Pregnancy and Childbirth Labour

Interventions

Single injection of 250 mg of 17-hydroxyprogesterone acetate versus placebo saline injection.

Sponsors

University of Malaya Medical Centre (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Suspected preterm labour (based on presence of contractions and/or cervical changes) 2. 22 to 35 weeks gestation 3. Scheduled for standard tocolysis and prophylactic antenatal corticosteroids

Exclusion criteria

Exclusion criteria: 1. Multiple gestations 2. Foetal death 3. Membrane rupture 4. Maternal pyrexia more than 38°C 5. Indications for immediate delivery

Design outcomes

Primary

MeasureTime frame
1. Delivery within 48 hours 2. Delivery within seven days—

Secondary

MeasureTime frame
1. Delivery before 34 weeks 2. Delivery before 37 weeks 3. Mode delivery 4. Birth weight 5. Gestational age at delivery 6. Apgar score (five minute) 7. Umbilical cord blood pH at birth 8. Admission to the neonatal unit 9. Perinatal mortality 10. Neonatal morbidity including Respiratory Distress Syndrome (RDS), IntraVentricular Haemorrhage (IVH), Necrotising EnteroColitis (NEC), surfactant use, mechanical ventilation—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026