Clinical trial NCT03346629: Outpatient Service for Mid-trimester Termination of Pregnancy
Official title: Evaluating the Safety, Acceptability and Feasibility of an Outpatient "Day Procedure" Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion in Second Trimester
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: CREHPA
name: Kathmandu Medical College and Teaching Hospital
name: Kathmandu Model Hospital
name: KIST Medical College
First posted: 2017-11-17
Enrollment: 230
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.


Eligibility criteria: Inclusion Criteria:

* Have an ongoing pregnancy of 13-18 weeks gestation
* Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
* Has access to a phone where she can be reached at the 2-week follow-up
* Be willing to follow study procedures

Exclusion Criteria:

* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery
* More than one prior cesarean delivery
* Living more than 2 hours away from the hospital

Primary outcomes:
measure: Successful medical abortion
timeFrame: 0 - 48 hours after first dose of mifepristone
Secondary outcomes:
measure: Induction-to-abortion interval
timeFrame: 0 - 48 hours after first misoprostol dose
measure: Total dose of misoprostol
timeFrame: 0 - 48 hours after first misoprostol dose
measure: Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
timeFrame: 2 weeks after initial visit
measure: Tasks performed by certified staff
timeFrame: 0 - 72 hours after receipt of mifepristone
measure: Hospital admission time
timeFrame: Within 0 - 48 hours after the second dose of misoprostol
measure: Side Effects
timeFrame: 0 - 48 hours after first dose of misoprostol
measure: Initiation-to-abortion interval
timeFrame: 0 - 72 hours after receipt of mifepristone
Other outcomes:
Locations:
city: Imadol
country: Nepal
facility: KIST Medical College, Teaching Hospital
state: Lalitpur
city: Kathmandu
country: Nepal
facility: Kathmandu Medical College
city: Kathmandu
country: Nepal
facility: Kathmandu Model Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Monica Dragoman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kathmandu Medical College
name: Chanda Karki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Dina Abbas, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CREHPA
name: Anand Tamang, MPhil
role: PRINCIPAL_INVESTIGATOR
References: