Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks

NCT05119439 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 1050
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

Brief Summary

This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.

Conditions

Medical Abortion

Keywords

mifepristone; misoprostol; first trimester; abortion

Outcome Measures

Primary Outcomes (1)

• Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason

  Proportion of women who achieve complete abortion with medication only and without aspiration or D\&E

  7-36 days after initial visit

Secondary Outcomes (3)

• Proportion of participants who report each individual side effect

  7-14 days after initial visit

• Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization

  7-14 days after initial visit

• Proportion of participants who determine method acceptable

  7-36 days after initial visit

Study Arms (2)

71-77 days of gestational age

NO INTERVENTION

Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).

78-84 days of gestational age

EXPERIMENTAL

Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.

Drug: Mifepristone + 2 doses of misoprostol 800 mcg

Interventions

Mifepristone + 2 doses of misoprostol 800 mcg DRUG

Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants.

78-84 days of 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:

• Seeking medical abortion services at one of the enrolling clinics
• Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days
• Meet standard eligibility criteria for medical abortion
• Be able to return to clinic for in-person follow up
• Speak/read/write English or Spanish
• Have access to a mobile phone with texting capability
• Be in general good health
• Be willing and able to sign consent forms
• Agree to comply with the study procedures and follow up.

You may not qualify if:

• Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.)
• With known allergies or other contraindications to mifepristone or misoprostol
• Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Society of Family Planning: collaborator

Study Sites (6)

University of Hawaii

Hilo, Hawaii, 96720, United States

Location

University of Hawaii

Honolulu, Hawaii, 96822, United States

Location

Planned Parenthood North Central States

Saint Paul, Minnesota, 55114, United States

Location

Philadelphia Women's Center

Philadelphia, Pennsylvania, 19106, United States

Location

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky

Federal Way, Washington, 98003, United States

Location

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

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: November 5, 2021
• First Posted: November 15, 2021
• Study Start: October 7, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

US (6)