Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

Second Trimester Abortion Clinical Trial

Official title:

Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04063904
• Other study ID #: 1044
• Status: Terminated
• Phase: Phase 4
• Start date: October 16, 2019
• Est. completion date: April 3, 2021

Study information

• Verified date: July 2021
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 3, 2021
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Second Trimester Abortion

Intervention

Drug:
• Mifepristone
One 200 mg pill (oral)
• Misoprostol
Two 400 mcg pills (sublingual)

Locations

Country	Name	City	State
Colombia	Fundacion Orientame	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful medical abortion	Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.	0-60 hours after mifepristone
Secondary	Induction-to-abortion interval	Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion	0-12 hours after misoprostol
Secondary	Initiation-to-abortion interval	Time (median min/hrs) from mifepristone administration until fetal and placental expulsion	0-60 hours after mifepristone
Secondary	Total dose of misoprostol administered	Mean number of misoprostol doses administered to achieve abortion	0-12 hours after misoprostol
Secondary	Method safety	Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications	Two weeks after mifepristone
Secondary	Tasks performed by clinic staff	Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider	From enrollment through discharge from care (approx. 3 days)
Secondary	Total clinic time	Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day	0-12 hours from arrival at clinic on day of induction with misoprostol
Secondary	Pain with procedure	Mean pain score (scale 0-10)	0-12 hours after first misoprostol dose
Secondary	Side effects	Report of side effects and proportion of participants who experienced each one	0-12 hours after first misoprostol dose
Secondary	Satisfaction with procedure	Proportion of participants who reported the procedure as satisfactory or very satisfactory	Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose