The Extended Gestational Age Medical Abortion Study

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

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.

Study Overview

• Status: Completed
• Conditions: Medical Abortion
• Intervention / Treatment: Drug: Mifepristone and misoprostol

• Study Type: Interventional
• Enrollment (Actual): 1400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Georgia
  • Tblisi, Georgia
    • Zhordania Institute of Human Reproduction
• India
  • Nagpur, India
    • Government Medical College (GMC)
  • Solapur, India
    • Naval Nursing Home
• Tunisia
  • Tunis, Tunisia
    • La Rabta Maternity Hospital
• Ukraine
  • Odessa, Ukraine
    • Central District Maternity House
  • Simferopol, Ukraine
    • Maternity Hospital No.2
• United States
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Presidential Women's Center
  • Illinois
    • Chicago, Illinois, United States, 60630
      • Family Planning Associates Medical Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts
  • Minnesota
    • St. Paul, Minnesota, United States, 55116
      • Planned Parenthood, Minnesota, North Dakota, South Dakota
  • New York
    • New York, New York, United States, 10012
      • Planned Parenthood of New York City
  • Texas
    • Waco, Texas, United States, 76710
      • Planned Parenthood, Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion	7-36 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of individual side effects experienced by participants	7-14 days
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
Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began	7-14 days
Average number of missed days of work or school due to the abortion procedure	7-14 days

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Yael Swica, MD, MPH, Gynuity Health Projects

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (ESTIMATE): October 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1.2.2