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The Extended Gestational Age Medical Abortion Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00997347
First received: October 1, 2009
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Medical Abortion
 Drug: Mifepristone and misoprostol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion [ Time Frame: 7-36 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of individual side effects experienced by participants [ Time Frame: 7-14 days ] [ Designated as safety issue: Yes ]
  • Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain) [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Average number of missed days of work or school due to the abortion procedure [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]

Enrollment: 1400
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 64-70 days' gestational age
Women whose pregnancies are estimated to have a gestational age of 64-70 days
 Drug: Mifepristone and misoprostol

200 mg oral mifepristone

800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone
No Intervention: 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.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997347

Locations
United States, Florida
Presidential Women's Center
West Palm Beach, Florida, United States, 33407
United States, Illinois
Family Planning Associates Medical Group
Chicago, Illinois, United States, 60630
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
United States, Minnesota
Planned Parenthood, Minnesota, North Dakota, South Dakota
St. Paul, Minnesota, United States, 55116
United States, New York
Planned Parenthood of New York City
New York, New York, United States, 10012
United States, Texas
Planned Parenthood, Central Texas
Waco, Texas, United States, 76710
Georgia
Zhordania Institute of Human Reproduction
Tblisi, Georgia
India
Government Medical College (GMC)
Nagpur, India
Naval Nursing Home
Solapur, India
Tunisia
La Rabta Maternity Hospital
Tunis, Tunisia
Ukraine
Central District Maternity House
Odessa, Ukraine
Maternity Hospital No.2
Simferopol, Ukraine
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Yael Swica, MD, MPH Gynuity Health Projects
Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00997347     History of Changes
Other Study ID Numbers: 1.2.2
Study First Received: October 1, 2009
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

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 19, 2013