RecruitingPhase 3ACTRN12624000103561

Mifepristone versus placebo to increase the rate of spontaneous labour in people with a prior caesarean: A double blind randomised controlled trial (Mi-labourTrial)


Sponsor

University of Auckland

Enrollment

168 participants

Start Date

Jul 4, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This trial — called the Mi-labour Trial — is testing whether a single dose of a medication called mifepristone can help pregnant people who have previously had a caesarean birth go into labour spontaneously. Mifepristone is a medication that works by blocking progesterone, a hormone that helps maintain pregnancy, and it is already used in other contexts. The theory is that it may gently encourage the cervix to ripen and labour to begin naturally, potentially reducing the need for formal induction of labour and the associated risks in people with a previous caesarean scar. Participants will receive either mifepristone or a placebo tablet by mouth, and neither participants nor their doctors will know which has been given (double-blind). Researchers will then track whether labour starts naturally within 48 hours, and will monitor outcomes for both the birthing person and the baby. The trial is being run across participating sites and is open to people in the final weeks of pregnancy. You may be eligible if you are pregnant with a single baby in a head-down position, have had one or two previous caesarean births, are planning a vaginal birth this time, have intact membranes, and are between 37 and 42 weeks pregnant. You are not eligible if you have had a classical (vertical) caesarean incision, have fetal growth restriction with poor blood flow on Doppler, or if induction or caesarean is already planned within the next 48 hours.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 re

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.


Locations(1)

New Zealand

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ACTRN12624000103561