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

Not Applicable

Completed

• Conditions: Preterm prelabour rupture of membranes; Pregnancy and Childbirth; Preterm labour

• Registration Number: ISRCTN44485060
• Lead Sponsor: ational Health and Medical Research Council (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-19
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1812

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eonatal sepsis

Secondary Outcome Measures

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