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

Phase 4TerminatedNCT04063904

Gynuity Health Projects16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Second Trimester Abortion

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 0-60 hours after mifepristone

Secondary Outcomes

Induction-to-abortion interval

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

Time frame: 0-12 hours after misoprostol

Initiation-to-abortion interval

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

Time frame: 0-60 hours after mifepristone

Total dose of misoprostol administered

Mean number of misoprostol doses administered to achieve abortion

Time frame: 0-12 hours after misoprostol

Method safety

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

Time frame: Two weeks after mifepristone

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

Time frame: From enrollment through discharge from care (approx. 3 days)

Total clinic time

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

Time frame: 0-12 hours from arrival at clinic on day of induction with misoprostol

Pain with procedure

Mean pain score (scale 0-10)

Time frame: 0-12 hours after first misoprostol dose

Side effects

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

Time frame: 0-12 hours after first misoprostol dose

Satisfaction with procedure

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

Time frame: Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose