Medical Abortion for Emergency Contraception Failure

NCT ID: NCT00677755

Last Updated: 2008-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-11-30

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 by mifepristone EC failure.

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 prefer to choose a medical abortion in order to avoid anesthesia, over a surgical operation. However, medical termination of a pregnancy after mifepristone EC failure has not been studied although it has already been extensively practiced by empirical means in China. There is no clarification in literature as to whether mifepristone is still effective in medical abortion with its previous failure experience in EC. This randomized study was aimed 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.

Conditions

Emergency Contraception; Abortion, Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mf+Ms

The women in mifepristone combined misoprostol group (Mf+Ms) received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally

Group Type: EXPERIMENTAL

mifepristone combined misoprostol

Intervention Type: DRUG

women received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally

Ms-alone

The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3.

Group Type: EXPERIMENTAL

misoprostol alone protocol

Intervention Type: DRUG

patients were only administered 0.8 mg of misoprostol orally on day 3.

Interventions

mifepristone combined misoprostol

women received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally

Intervention Type: DRUG

misoprostol alone protocol

patients were only administered 0.8 mg of misoprostol orally on day 3.

Intervention Type: DRUG

Eligibility 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

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taizhou Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taizhou hospital of Zhejiang Province

Principal Investigators

YiYang Zhu, MD

Role: STUDY_DIRECTOR

Centra for Reproductive Medicine of Taizhou hospital

Locations

Taizhou Hospital of zhejiang Province

Taizhou, Zhejiang, China

Countries

China

Other Identifiers

Taizhou2004-08

Identifier Type: -

Identifier Source: org_study_id