Mifepristone versus placebo to increase the rate of spontaneous labour in people with a prior caesarean: A double blind randomised controlled trial (Mi-labourTrial)
Phase 3
Recruiting
- Conditions
- vaginal birth after caesareanlabourReproductive Health and Childbirth - Other reproductive health and childbirth disorders
- Registration Number
- ACTRN12624000103561
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 168
Inclusion Criteria
Pregnant people with a live singleton and cephalic presentation
History of one or two prior caesarean births
Intention to deliver vaginally
Intact membranes
Normal CTG prior to randomisation
Maternal age 16-50 years
Gestational age between 36 6/7 and 41 6/7 weeks gestation
Exclusion Criteria
History of classical caesarean birth or other major uterine surgery including transmural myomectomy
Fetal malpresentation (including breech or transverse presentation) or other contraindication to vaginal birth or induction of labour
Fetal growth restriction with Absent or Reverse End Diastolic Flow noted on umbilical artery Doppler
Rupture of amniotic membranes
Planned induction of labour or caesarean birth within the next 48 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spontaneous labour onset<br><br>This is defined as regular uterine contractions causing cervical change (with a minimum cervical dilation of 3 centimetres). Confirmed with cardiotocography or uterine palpation and a cervical examination by either a midwife or doctor. Confirmed via electronic medical record review. [ From drug ingestion to 48 hours post drug ingestion]
- Secondary Outcome Measures
Name Time Method