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.

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 Overview

• Status: Completed
• Conditions: Abortion, Induced; Emergency Contraception
• Intervention / Treatment: Drug: mifepristone combined misoprostol; Drug: misoprostol alone protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Taizhou City, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
Experimental: Ms-alone; The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3.	Drug: misoprostol alone protocol; patients were only administered 0.8 mg of misoprostol orally on day 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
complete abortion rate	study day 17 (14 days after misoprostol)

Secondary Outcome Measures

Outcome Measure	Time Frame
side effects, timing of expulsion and duration of bleeding	timing of expulsion at day 17, others at 45day after abortion

Collaborators and Investigators

• Sponsor: Taizhou Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: May 7, 2008
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (Estimate): May 14, 2008

Study Record Updates

• Last Update Posted (Estimate): May 16, 2008
• Last Update Submitted That Met QC Criteria: May 15, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: emergency contraception; mifepristone; Medical abortion
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: Taizhou2004-08