Abortion, Induced Clinical Trial
Official title:
Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.
Verified date | May 2008 |
Source | Taizhou Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 394 |
Est. completion date | November 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Taizhou Hospital of zhejiang Province | Taizhou City | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Taizhou Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | complete abortion rate | study day 17 (14 days after misoprostol) | No | |
Secondary | side effects, timing of expulsion and duration of bleeding | timing of expulsion at day 17, others at 45day after abortion | Yes |
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