Medical Abortion for Emergency Contraception Failure

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taizhou Hospital
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Participants included in the study were women aged 16 years or older

• with good general health,

• experiencing a mifepristone emergency contraception failure,

• presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan, with a crown-rump length compatible within 56 days of gestation at the enrolled day, and

• seeking a medical abortion for unwanted pregnancy.

• Women who had a threatened abortion or a failure pregnancy were also included.

• Participants were required to sign an informed consent form before enrolment, willing to comply with the schedule of follow-up visits and willing to undergo surgical aspiration if indicated.

Exclusion Criteria:

• The exclusion criteria included suspected or proven ectopic pregnancy,

• allergy or contraindications for mifepristone (chronic systemic corticosteroid therapy, adrenal insufficiency) or misoprostol (hypertension, mitral stenosis, severe asthma, glaucoma, sickle cell anemia and hypotension),

• history or evidence of thromboembolism, cardiovascular disease or liver disease, hemoglobin ≤ 90 g/l, heavy smoking (more than 10 per day),

• presence of an intrauterine device, and breastfeeding.

• Other exclusion criteria included participants who had EC failure because incorrect use, for example, having further unprotected intercourse after EC.