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

• Sponsor: Gynuity Health Projects (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04063904
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Second Trimester Abortion	Drug: Mifepristone; Drug: Misoprostol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
• Actual Study Start Date: Oct 16, 2019
• Actual Primary Completion Date: Apr 3, 2020
• Actual Study Completion Date: Apr 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mifepristone and misoprostol Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion.	Drug: Mifepristone; One 200 mg pill (oral); Drug: Misoprostol; Two 400 mcg pills (sublingual)

Outcome Measures

Primary Outcome Measures

1. Successful medical abortion [0-60 hours after mifepristone]

   Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.

Secondary Outcome Measures

1. Induction-to-abortion interval [0-12 hours after misoprostol]

   Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion

2. Initiation-to-abortion interval [0-60 hours after mifepristone]

   Time (median min/hrs) from mifepristone administration until fetal and placental expulsion

3. Total dose of misoprostol administered [0-12 hours after misoprostol]

   Mean number of misoprostol doses administered to achieve abortion

4. Method safety [Two weeks after mifepristone]

   Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications

5. Tasks performed by clinic staff [From enrollment through discharge from care (approx. 3 days)]

   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

6. Total clinic time [0-12 hours from arrival at clinic on day of induction with misoprostol]

   Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day

7. Pain with procedure [0-12 hours after first misoprostol dose]

   Mean pain score (scale 0-10)

8. Side effects [0-12 hours after first misoprostol dose]

   Report of side effects and proportion of participants who experienced each one

9. Satisfaction with procedure [Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose]

   Proportion of participants who reported the procedure as satisfactory or very satisfactory

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacion Orientame	Bogotá		Colombia

Sponsors and Collaborators

• Gynuity Health Projects

Investigators

• Principal Investigator: Ilana G Dzuba, MHS, Gynuity Health Projects
• Principal Investigator: Maria Mercedes Vivas, MD, Fundacion Orientame
• Study Director: Juliette Ortiz, Fundacion Orientame
• Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynuity Health Projects
• ClinicalTrials.gov Identifier: NCT04063904
• Other Study ID Numbers: 1044
• First Posted: Aug 21, 2019
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Gynuity Health Projects: medical abortion; mifepristone
• Additional relevant MeSH terms: Misoprostol; Mifepristone

Study Results

No Results Posted as of Jul 23, 2021