Medical Abortion for Emergency Contraception Failure

NCT00677755 | Completed

• 1 other identifier: Taizhou2004-08
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergency Contraception; Abortion, Induced

Keywords

Medical abortion; emergency contraception; mifepristone

Outcome Measures

Primary Outcomes (1)

• complete abortion rate

  study day 17 (14 days after misoprostol)

Secondary Outcomes (1)

• side effects, timing of expulsion and duration of bleeding

  timing of expulsion at day 17, others at 45day after abortion

Study Arms (2)

Mf+Ms

EXPERIMENTAL

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

Drug: mifepristone combined misoprostol

Ms-alone

EXPERIMENTAL

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

Drug: misoprostol alone protocol

Interventions

mifepristone combined misoprostol 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

Mf+Ms

misoprostol alone protocol DRUG

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

Ms-alone

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (1)

Taizhou Hospital of zhejiang Province

Taizhou, Zhejiang, 317000, China

Location

Study Officials

• YiYang Zhu, MD

  Centra for Reproductive Medicine of Taizhou hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 14, 2008
• Study Start: October 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

CN (1)