Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1400 participants
INTERVENTIONAL
2009-07-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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64-70 days' gestational age
Women whose pregnancies are estimated to have a gestational age of 64-70 days
Mifepristone and misoprostol
200 mg oral mifepristone
800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone
57-63 days' gestational age
Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range.)
No interventions assigned to this group
Interventions
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Mifepristone and misoprostol
200 mg oral mifepristone
800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Yael Swica, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Hillary Bracken, PhD
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
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Presidential Women's Center
West Palm Beach, Florida, United States
Family Planning Associates Medical Group
Chicago, Illinois, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Planned Parenthood, Minnesota, North Dakota, South Dakota
Saint Paul, Minnesota, United States
Planned Parenthood of New York City
New York, New York, United States
Planned Parenthood, Central Texas
Waco, Texas, United States
Zhordania Institute of Human Reproduction
Tbilisi, , Georgia
Government Medical College (GMC)
Nagpur, , India
Naval Nursing Home
Solapur, , India
La Rabta Maternity Hospital
Tunis, , Tunisia
Central District Maternity House
Odesa, , Ukraine
Maternity Hospital No.2
Simferopol, , Ukraine
Countries
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References
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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.
Other Identifiers
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1.2.2
Identifier Type: -
Identifier Source: org_study_id
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