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Immediate delivery versus expectant care in women with ruptured membranes close to term

A randomised controlled trial of immediate delivery versus expectant care in women with ruptured membranes close to term

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44485060
Enrollment
1812
Registered
2005-04-19
Start date
2005-01-01
Completion date
Unknown
Last updated
2018-01-15

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

Conditions

Preterm prelabour rupture of membranes Pregnancy and Childbirth Preterm labour

Interventions

Immediate delivery (within 24 hours) versus expectant management. Added as of 13/02/2009: The duration of follow-up is 4 months post estimated date of confinement (EDC) or the baby's due delivery da

Sponsors

National Health and Medical Research Council (Australia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 12/02/2009: Singleton pregnancies, with confirmed ruptured membranes from 34 weeks to 36 weeks and 6 days gestation. Previous inclusion criteria: Pregnant women with preterm prelabour rupture of the membranes at 34 - 36 weeks

Exclusion criteria

Exclusion criteria: Women who are in established labour, have clinical evidence of chorioamnionitis or other indications for immediate delivery such as meconium staining of the liquor or an antepartum haemorrhage or any other contraindication to expectant management will be excluded from the study. The presence of Group B streptococcus on urine or genital tract culture will not be a specific indication for exclusion from the study.

Design outcomes

Primary

MeasureTime frame
Neonatal sepsis

Secondary

MeasureTime frame
1. Secondary infant outcomes: 1.1. Respiratory distress 1.2. Perinatal mortality 1.3. Duration of stay in special care unit 1.4. Duration of stay in hospital 1.5. Birth weight 1.6. Apgar score at 5 minutes 1.7. Any assisted ventilation 1.8. Early infant development 2. Secondary maternal outcomes: 2.1. Chorioamnionitis 2.2. Endometritis treated with antibiotics 2.3. Post-partum fever 2.4. Placental abruption 2.5. Induction of labour 2.6. Failed induction of labour 2.7. Caesarean section 2.8. Assisted vaginal delivery 2.9. Maternal satisfaction 2.10. Views of care 2.11. Duration of hospitalisation 2.12. Antenatally and postnatally, time to fully establish breast feeding 2.13. Maternal emotional wellbeing 2.14. Anxiety and depression

Countries

Argentina, Australia, New Zealand, Norway, Poland, Romania, South Africa, United Kingdom

Outcome results

None listed

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