Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone - Full Text View

Purpose

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.

Condition	Intervention	Phase
Complete Abortion	Drug: medical abortion	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals

Resource links provided by NLM:

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Number of women with a complete abortion using study drug alone without recourse to surgical intervention [ Time Frame: one week from initial treatment ] [ Designated as safety issue: Yes ]
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens

Secondary Outcome Measures:

Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam [ Time Frame: one week from initial treatment ] [ Designated as safety issue: Yes ]
Proportion of women who report the side effects after their treatment to be acceptable as a measure of acceptability with the buccal misoprostol route (with and without mifepristone)
Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration [ Time Frame: one week from initial treatment ] [ Designated as safety issue: Yes ]
To assess the rate of complete uterine evacuation with study drugs alone and rate of any adverse events among participants after use of buccal misoprostol (alone or with mifepristone)as a measure of its utility in early medical abortion compared to other regimens
Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam [ Time Frame: one week from initial treatment ] [ Designated as safety issue: No ]
Proportion of participants reporting that they found the medical abortion regimen assigned to them to be acceptable
Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance [ Time Frame: one week from initial treatment ] [ Designated as safety issue: No ]
Proportion of women who report taking mifepristone and misoprostol at home on their own as instructed as a measure of compliance and feasibility of a protocol with at home administration of study drugs

Enrollment:	441
Study Start Date:	May 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
mifepristone+misoprostol 200 mg mifepristone + 800 mcg buccal misoprostol	Drug: medical abortion pregnancy termination with drugs
Experimental: buccal misoprostol 2 doses of 800 mcg buccal misoprostol	Drug: medical abortion pregnancy termination with drugs

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
Able to consent to study participation.

Exclusion Criteria:

Gestational age > 63 days LMP
Confirmed or suspected ectopic or molar pregnancy
Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387256

Locations

Tunisia
La Rabta Maternity Hospital
Tunis, Tunisia
Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam

Sponsors and Collaborators

Gynuity Health Projects

More Information

No publications provided

Responsible Party:	Dr Beverly Winikoff, Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT01387256 History of Changes
Other Study ID Numbers:	1.2.1
Study First Received:	May 2, 2011
Last Updated:	July 18, 2011
Health Authority:	Vietnam: Ministry of Health Tunisia: Ministry of Public Health

Keywords provided by Gynuity Health Projects:

abortion
mifepristone
misoprostol
with gestations > 63 days LMP

Additional relevant MeSH terms:

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 May 23, 2013