RecruitingPhase 2ACTRN12620000596909

Progesterone after mifepristone, for women whose decision has changed after commencing a medical termination of pregnancy - a pilot clinical trial

Progesterone after mifepristone – pilot for efficacy and reproducibility (PAMper Trial): a prospective single-arm clinical trial of progesterone after mifepristone for women whose decision has changed regarding medical termination of their pregnancy.

Sponsor

University of New England

Enrollment

52 participants

Start Date

Oct 16, 2020

Study Type

Interventional

Conditions

Pregnancy continuation after mifepristone

Summary

Medical termination of pregnancy (MTOP) is a two stage process, women take mifepristone first, then take misoprostol 36 to 48 hours later. If women do not take misoprostol after taking mifepristone the continuing pregnancy rate varies from 0 to 25%.[1] There is evidence that some women decide they want to continue their pregnancy after initiating a MTOP. Currently there are no clinical guidelines for managing these women. The PAMper Trial aims to assess the efficacy of progesterone after mifepristone as % of viable pregnancies 2 weeks after initiation of progesterone, as determined by ultrasound, and % of live births. It will also report on relevant clinical factors associated with the use of progesterone after mifepristone and explore the experiences of women who take mifepristone then decide they want to continue their pregnancy. Participants will be women who have taken mifepristone then contact the trial centre because they now want to continue their pregnancy. It is expected that the pregnancy continuation rate 2 weeks after commencing treatment will be statistically greater than 25% and could be be over 50%. [1] Davenport ML, Delgado G, Harrison MP, Khauv V Embryo survival after mifepristone: a systematic review of the literature. Issues in Law & Medicine. 2017;32(1):3-18.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Medical termination of pregnancy (MTOP) is a two-step process: first, a woman takes a tablet called mifepristone to block pregnancy hormones, then 36–48 hours later she takes a second medication called misoprostol to complete the process. Some women change their minds after taking mifepristone but before taking misoprostol and want to try to continue the pregnancy. Currently, there are no clinical guidelines in Australia for how to manage this situation. This pilot trial is testing whether taking progesterone (a natural pregnancy hormone) after mifepristone can help maintain the pregnancy. The researchers want to find out what percentage of women who take progesterone after mifepristone go on to have a continuing pregnancy confirmed by ultrasound, and ultimately how many result in live births. You may be eligible if you are a woman living in Australia, aged 18–45, who has taken mifepristone within the last 72 hours as part of a medical termination and has NOT yet taken misoprostol, and who has now decided she wants to continue the pregnancy. You must not have any contraindications to progesterone (such as severe liver disease, certain cancers, or blood clotting disorders). You must be able to communicate in English or use an accredited interpreter.

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

Participants will take 4 x 100 mg progesterone capsules orally twice a day for 3 days then once a day at night (bedtime) for 16 days. Treatment with progesterone must be initiated within 72 hours of

Participants will take 4 x 100 mg progesterone capsules orally twice a day for 3 days then once a day at night (bedtime) for 16 days. Treatment with progesterone must be initiated within 72 hours of taking mifepristone. To monitor adherence participants will be asked to complete a medication record sheet and asked about progesterone use during their last follow up conversation with their prescriber.

Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12620000596909