Clinical trial NCT04063904: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Official title: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Second Trimester Abortion
Keywords: medical abortion
mifepristone
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\&E will be performed to complete the abortion.


Eligibility criteria: Inclusion Criteria:

1. Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
2. Meet legal criteria to obtain abortion
3. Be at least 18 years old
4. Have access to a phone where she can be reached for the 2-week follow up
5. Be willing to follow pilot study procedures

Exclusion Criteria:

1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
2. Any contraindications to vaginal delivery
3. More than one prior cesarean delivery
4. Staying more than 2 hours away from the clinic

Primary outcomes:
measure: Successful medical abortion
timeFrame: 0-60 hours after mifepristone
Secondary outcomes:
measure: Induction-to-abortion interval
timeFrame: 0-12 hours after misoprostol
measure: Initiation-to-abortion interval
timeFrame: 0-60 hours after mifepristone
measure: Total dose of misoprostol administered
timeFrame: 0-12 hours after misoprostol
measure: Method safety
timeFrame: Two weeks after mifepristone
measure: Tasks performed by clinic staff
timeFrame: From enrollment through discharge from care (approx. 3 days)
measure: Total clinic time
timeFrame: 0-12 hours from arrival at clinic on day of induction with misoprostol
measure: Pain with procedure
timeFrame: 0-12 hours after first misoprostol dose
measure: Side effects
timeFrame: 0-12 hours after first misoprostol dose
measure: Satisfaction with procedure
timeFrame: Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundacion Orientame
Study officials:
affiliation: Gynuity Health Projects
name: Ilana G Dzuba, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Orientame
name: Maria Mercedes Vivas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Orientame
name: Juliette Ortiz
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: