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

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

Inclusion Criteria7

  • Women who:
  • have ingested mifepristone within the last 72 hours to initiate MTOP
  • have not taken any misoprostol;
  • have no contraindications for use of progesterone, including known allergy or hypersensitivity to progesterone or to any of the excipients, severe hepatic dysfunction, undiagnosed vaginal bleeding, known missed miscarriage or ectopic pregnancy, mammary or genital tract carcinoma, thromboembolic disorders, thrombophlebitis, cerebral haemorrhage, or porphyria.
  • live in Australia;
  • provide the name of their usual or nominated medical practitioner; and
  • understand English, or utilise the assistance of an accredited interpreter if appropriate.

Exclusion Criteria5

  • Women who
  • are unable to take their first dose of progesterone within 72 hours of taking mifepristone;
  • are not living in Australia;
  • wish to continue with MTOP and take misoprostol; or
  • declined permission for communication between the trial coordinator and their usual or nominated medical practitioner regarding trial participation.

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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