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

Phase 2

Recruiting

• Conditions: Pregnancy continuation after mifepristone; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Reproductive Health and Childbirth - Abortion

• Registration Number: ACTRN12620000596909
• Lead Sponsor: niversity of New England

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viable pregnancy as determined by ultrasound.[Two weeks after intervention commencement.]