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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• complete abortion rate
  • Time Frame: study day 17 (14 days after misoprostol)
    Safety Issue?: No

Secondary Measures

• side effects, timing of expulsion and duration of bleeding
  • Time Frame: timing of expulsion at day 17, others at 45day after abortion
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Taizhou Hospital

Overall Clinical Trial Officials and Contacts

YiYang Zhu, MD Study Director Centra for Reproductive Medicine of Taizhou hospital  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00677755

Study ID Number: Taizhou2004-08

ClinicalTrials.gov Identifier: NCT00677755

Health Authority: China: Ministry of Health