Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation (XXGA)

Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial

To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

Study Overview

• Status: Completed
• Conditions: Medical Abortion
• Intervention / Treatment: Drug: Mifepristone followed by misoprostol 24-48 hours later

• Study Type: Interventional
• Enrollment (Actual): 719
• Phase: Phase 4

Contacts and Locations

Study Locations

• Azerbaijan
  • Baku, Azerbaijan
    • Scientific Research Institute of Obstetrics and Gynecology
• Georgia
  • Tbilisi, Georgia
    • David Gagua Clinic
• Mexico
  • Mexico City, Mexico
    • Clínica Comunitaria Santa Catarina
• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford GYN Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H. Stroger, Jr. Hospital of Cook County
    • Chicago, Illinois, United States, 60630
      • Family Planning Associates Medical Group
• Vietnam
  • Ho Chi Minh City, Vietnam
    • Hung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• intrauterine pregnancy between 64 days and 77 days' LMP
• eligible for medical abortion according to study doctor assessment
• willing and able to sign consent form
• 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

Exclusion Criteria:

• Have known allergies or present other contraindications to mifepristone or misoprostol

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: 71-77 days gestational age; Women whose pregnancies are estimated to have a gestational age of 71-77 days.	Drug: Mifepristone followed by misoprostol 24-48 hours later; 200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone
NO_INTERVENTION: 64-70 days gestational age; Women whose pregnancies are estimated to have a gestational age of 64-70 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	Measure Description	Time Frame
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason	Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason	7-36 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Individual Side Effects Experienced by Participants	Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants	7-14 days
Proportion of Women Who Determine Method Acceptable	overall acceptability, time to complete abortion, bleeding, side effects, pain	7-14 days
Proportion of Providers Who Determine Method Acceptable	As assessed by service provider semi-structured interviews	7-36 days

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Beverly Winikoff, MD,MPH, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (ESTIMATE): December 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 14, 2016
• Last Update Submitted That Met QC Criteria: July 13, 2016
• Last Verified: July 1, 2016

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: 1016