Prostaglandin Inpatient iNduction of labour Compared with BALLOon Outpatient iNduction of labour: a randomised controlled trial

Not Applicable

• Conditions: Induction of labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12614000039684
• Lead Sponsor: Mater Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Study Completion: 2018-12-01
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 695

Inclusion Criteria

All women with live singleton pregnancies greater than or equal to 37 weeks 0 days, booked for induction of labour because of post-term and/or social/elective reasons, and requiring cervical priming will be suitable for inclusion in this study

Exclusion Criteria

Major congenital abnormality
Multiple pregnancy
Intrauterine fetal death
Clinical suspicion or ultrasound diagnosis of fetal growth restriction
Any contraindication to vaginal birth
Indication for IOL other than post-term and/or social/elective reasons
Modified Bishops score = 7 at commencement of IOL
Women <18 years
Inability to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is a composite measure of neonatal outcome comprising one or more of:<br>a) Admission to neonatal critical care nursery<br>b) Need for intubation and/or external cardiac compressions<br>c) Neonatal academia, as measured by the proportion of babies born with cord arterial pH <7.10 <br>d) Hypoxic ischaemic encephalopathy<br>e) Neonatal seizure<br>f) Infection (as defined by neonatal antibiotic administration)<br>g) Persistent pulmonary hypertension of the newborn (PPHN)<br>[At time of birth]