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Medical Abortion for Emergency Contraception Failure

NCT ID: NCT00677755

Last Updated: 2008-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Emergency Contraception Abortion, Induced

Keywords

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Medical abortion emergency contraception mifepristone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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

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Taizhou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taizhou hospital of Zhejiang Province

Principal Investigators

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YiYang Zhu, MD

Role: STUDY_DIRECTOR

Centra for Reproductive Medicine of Taizhou hospital

Locations

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Taizhou Hospital of zhejiang Province

Taizhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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Taizhou2004-08

Identifier Type: -

Identifier Source: org_study_id