Clinical trial NCT05119439: Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks
Official title: An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Medical Abortion
Keywords: mifepristone
misoprostol
first trimester
abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2021-11-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
timeFrame: 7-36 days after initial visit
Secondary outcomes:
measure: Proportion of participants who report each individual side effect
timeFrame: 7-14 days after initial visit
measure: Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization
timeFrame: 7-14 days after initial visit
measure: Proportion of participants who determine method acceptable
timeFrame: 7-36 days after initial visit
Other outcomes:
Locations:
city: Hilo
country: United States
facility: University of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Saint Paul
country: United States
facility: Planned Parenthood North Central States
state: Minnesota
city: Philadelphia
country: United States
facility: Philadelphia Women's Center
state: Pennsylvania
city: Federal Way
country: United States
facility: Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
state: Washington
city: Tacoma
country: United States
facility: Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
state: Washington
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: