NCT00677755

Medical Abortion for Emergency Contraception Failure

Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Taizhou Hospital · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	misoprostol alone protocol	patients were only administered 0.8 mg of misoprostol orally on day 3.

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-09-01
• Completion: 2007-11-01
• First posted: 2008-05-14
• Last updated: 2008-05-16

Locations

1 site across 1 country: China