Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone

Complete Abortion Clinical Trial

Official title:

Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387256
• Other study ID #: 1.2.1
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2011
• Last updated: July 18, 2011
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2011
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of HealthTunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Abortion

Intervention

Drug:
• medical abortion
pregnancy termination with drugs

Locations

Country	Name	City	State
Tunisia	La Rabta Maternity Hospital	Tunis
Vietnam	Hung Vuong Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Tunisia,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women with a complete abortion using study drug alone without recourse to surgical intervention	Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens	one week from initial treatment	Yes
Secondary	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	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)	one week from initial treatment	Yes
Secondary	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	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	one week from initial treatment	Yes
Secondary	Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam	Proportion of participants reporting that they found the medical abortion regimen assigned to them to be acceptable	one week from initial treatment	No
Secondary	Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance	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	one week from initial treatment	No