Medical Abortion for Emergency Contraception Failure

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677755
• Other study ID #: Taizhou2004-08
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: May 15, 2008
• Start date: October 2004
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: Taizhou Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced
• Emergencies
• Emergency Contraception

Intervention

Drug:
• 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
• misoprostol alone protocol
patients were only administered 0.8 mg of misoprostol orally on day 3.

Locations

Country	Name	City	State
China	Taizhou Hospital of zhejiang Province	Taizhou City	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Country where clinical trial is conducted

China, 

Outcome

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