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

NCT02314754 | Completed Phase 4 DMC

• 1 other identifier: 1016
• Study Type: interventional
• Target: 719
• Locations: 5 countries
• Sites: 8

Brief Summary

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.

Conditions

Medical Abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of Individual Side Effects Experienced by Participants

  7-14 days

• Proportion of Women Who Determine Method Acceptable

  7-14 days

• Proportion of Providers Who Determine Method Acceptable

  7-36 days

Study Arms (2)

71-77 days gestational age

EXPERIMENTAL

Women whose pregnancies are estimated to have a gestational age of 71-77 days.

Drug: Mifepristone followed by misoprostol 24-48 hours later

64-70 days gestational age

NO INTERVENTION

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).

Interventions

Mifepristone followed by misoprostol 24-48 hours later DRUG

200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone

71-77 days gestational age

Eligibility Criteria

• Age: 11 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (8)

Hartford GYN Center

Hartford, Connecticut, 06106, United States

Location

Atlanta Women's Center

Atlanta, Georgia, 30342, United States

Location

John H. Stroger, Jr. Hospital of Cook CountY

Chicago, Illinois, 60612, United States

Location

Family Planning Associates Medical Group

Chicago, Illinois, 60630, United States

Location

Scientific Research Institute of Obstetrics and Gynecology

Baku, Azerbaijan

Location

David Gagua Clinic

Tbilisi, Georgia

Location

Clínica Comunitaria Santa Catarina

Mexico City, Mexico

Location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Study Officials

• Beverly Winikoff, MD,MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 11, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

GE (1); US (4); VN (1); AZ (1); ME (1)