None listed
Conditions
Brief summary
We hypothesize that the administration of a single 200mg oral dose of mifepristone will increase the rate of spontaneous onset of labour within 48 hours in pregnant people with a prior caesarean compared to placebo. We are performing a randomised controlled trial to assess this. Trial participants and investigators will be blinded to allocation.
Interventions
Mifepristone, 200mg, orally, given as a single dose, encapsulated in opaque capsule cover, administered to participants who are at least 36 weeks 6 days gestational age, under direct supervision by research staff.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
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
Outcome results
None listed