Medical Abortion for Emergency Contraception Failure
This study has been completed.
Sponsor:
Taizhou Hospital
Information provided by:
Taizhou Hospital
ClinicalTrials.gov Identifier:
NCT00677755
First received: May 7, 2008
Last updated: May 15, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Emergency Contraception Abortion, Induced |
Drug: mifepristone combined misoprostol Drug: misoprostol alone protocol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone. |
Resource links provided by NLM:
Further study details as provided by Taizhou Hospital:
Primary Outcome Measures:
- complete abortion rate [ Time Frame: study day 17 (14 days after misoprostol) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- side effects, timing of expulsion and duration of bleeding [ Time Frame: timing of expulsion at day 17, others at 45day after abortion ] [ Designated as safety issue: Yes ]
| Enrollment: | 394 |
| Study Start Date: | October 2004 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677755
Locations
| China, Zhejiang | |
| Taizhou Hospital of zhejiang Province | |
| Taizhou City, Zhejiang, China, 317000 | |
Sponsors and Collaborators
Taizhou Hospital
Investigators
| Study Director: | YiYang Zhu, MD | Centra for Reproductive Medicine of Taizhou hospital |
More Information
No publications provided
| Responsible Party: | YiYang Zhu/Centra for Reproductive Medicine, Taizhou hospital of Zhejiang Province |
| ClinicalTrials.gov Identifier: | NCT00677755 History of Changes |
| Other Study ID Numbers: | Taizhou2004-08 |
| Study First Received: | May 7, 2008 |
| Last Updated: | May 15, 2008 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Taizhou Hospital:
|
Medical abortion emergency contraception mifepristone |
Additional relevant MeSH terms:
|
Emergencies Disease Attributes Pathologic Processes Mifepristone Misoprostol Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on June 18, 2013