The Extended Gestational Age Medical Abortion Study

Medical Abortion Clinical Trial

Official title:

The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997347
• Other study ID #: 1.2.2
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2009
• Last updated: June 28, 2012
• Start date: July 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• intrauterine pregnancy of greater than 56 days and less than 71 days

• eligible for medical abortion according to study doctor assessment

• willing and able to sign consent forms

• speak English or Spanish (in US sites); speak the local language(s) (in international sites)

• agree to comply with the study procedures and visit schedule

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Drug:
• Mifepristone and misoprostol
200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone

Locations

Country	Name	City	State
Georgia	Zhordania Institute of Human Reproduction	Tblisi
India	Government Medical College (GMC)	Nagpur
India	Naval Nursing Home	Solapur
Tunisia	La Rabta Maternity Hospital	Tunis
Ukraine	Central District Maternity House	Odessa
Ukraine	Maternity Hospital No.2	Simferopol
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts
United States	Family Planning Associates Medical Group	Chicago	Illinois
United States	Planned Parenthood of New York City	New York	New York
United States	Planned Parenthood, Minnesota, North Dakota, South Dakota	St. Paul	Minnesota
United States	Planned Parenthood, Central Texas	Waco	Texas
United States	Presidential Women's Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

United States,  Georgia,  India,  Tunisia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion		7-36 days
Secondary	Proportion of individual side effects experienced by participants		7-14 days
Secondary	Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)		7-14 days
Secondary	Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began		7-14 days
Secondary	Average number of missed days of work or school due to the abortion procedure		7-14 days