None listed
Conditions
Brief 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.
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 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.
Sponsors
University of New England
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed