Clinical trial NCT00997347: The Extended Gestational Age Medical Abortion Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medical Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion
timeFrame: 7-36 days
Secondary outcomes:
measure: Proportion of individual side effects experienced by participants
timeFrame: 7-14 days
measure: Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)
timeFrame: 7-14 days
measure: Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began
timeFrame: 7-14 days
measure: Average number of missed days of work or school due to the abortion procedure
timeFrame: 7-14 days
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Presidential Women's Center
state: Florida
city: Chicago
country: United States
facility: Family Planning Associates Medical Group
state: Illinois
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
city: St. Paul
country: United States
facility: Planned Parenthood, Minnesota, North Dakota, South Dakota
state: Minnesota
city: New York
country: United States
facility: Planned Parenthood of New York City
state: New York
city: Waco
country: United States
facility: Planned Parenthood, Central Texas
state: Texas
city: Tblisi
country: Georgia
facility: Zhordania Institute of Human Reproduction
city: Nagpur
country: India
facility: Government Medical College (GMC)
city: Solapur
country: India
facility: Naval Nursing Home
city: Tunis
country: Tunisia
facility: La Rabta Maternity Hospital
city: Odessa
country: Ukraine
facility: Central District Maternity House
city: Simferopol
country: Ukraine
facility: Maternity Hospital No.2
Study officials:
affiliation: Gynuity Health Projects
name: Yael Swica, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Hillary Bracken, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.