Status:
COMPLETED
Medical Abortion for Emergency Contraception Failure
Lead Sponsor:
Taizhou Hospital
Conditions:
Emergency Contraception
Abortion, Induced
Eligibility:
FEMALE
16-40 years
Phase:
NA
Brief 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 ...
Detailed Description
Women usually request an abortion when they have experienced an emergency contraception (EC) failure; this population represents 13% of all early pregnancy terminations in China. Many women would pref...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00677755
Start Date
October 1 2004
End Date
November 1 2007
Last Update
May 16 2008
Active Locations (1)
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1
Taizhou Hospital of zhejiang Province
Taizhou, Zhejiang, China, 317000