Medical Abortion for Emergency Contraception Failure - Full Text View

Sponsored by:	Taizhou Hospital
Information provided by:	Taizhou Hospital
ClinicalTrials.gov Identifier:	NCT00677755

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

MedlinePlus related topics: Abortion Birth Control

Drug Information available for: Mifepristone Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.

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
Mf+Ms: Experimental 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
Ms-alone: Experimental 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 Province
Taizhou Hospital of zhejiang Province
Taizhou City, Zhejiang Province, China, 317000

Sponsors and Collaborators

Taizhou Hospital

Investigators

Study Director:

YiYang Zhu, MD

Centra for Reproductive Medicine of Taizhou hospital

More Information

Responsible Party:	Taizhou hospital of Zhejiang Province ( YiYang Zhu/Centra for Reproductive Medicine )
Study ID Numbers:	Taizhou2004-08
Study First Received:	May 7, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00677755
Health Authority:	China: Ministry of Health

Keywords provided by Taizhou Hospital:

Medical abortion
emergency contraception
mifepristone

Study placed in the following topic categories:

Misoprostol
Emergencies
Mifepristone

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Disease Attributes
Oxytocics
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 14, 2009