Outpatient Service for Mid-trimester Termination of Pregnancy

Abortion in Second Trimester Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346629
• Other study ID #: 1039
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion in Second Trimester

Intervention

Drug:
• Mifepristone + Misoprostol
A single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs.

Locations

Country	Name	City	State
Nepal	KIST Medical College, Teaching Hospital	Imadol	Lalitpur
Nepal	Kathmandu Medical College	Kathmandu
Nepal	Kathmandu Model Hospital	Kathmandu

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	CREHPA, Kathmandu Medical College and Teaching Hospital, Kathmandu Model Hospital, KIST Medical College

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful medical abortion	Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction	0 - 48 hours after first dose of mifepristone
Secondary	Induction-to-abortion interval	Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta	0 - 48 hours after first misoprostol dose
Secondary	Total dose of misoprostol	Average number of doses of misoprostol	0 - 48 hours after first misoprostol dose
Secondary	Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications	Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications	2 weeks after initial visit
Secondary	Tasks performed by certified staff	Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge)	0 - 72 hours after receipt of mifepristone
Secondary	Hospital admission time	Average total hospital admission time	Within 0 - 48 hours after the second dose of misoprostol
Secondary	Side Effects	Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale)	0 - 48 hours after first dose of misoprostol
Secondary	Initiation-to-abortion interval	Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta	0 - 72 hours after receipt of mifepristone