Outpatient Service for Mid-trimester Termination of Pregnancy

NCT03346629 | Completed Phase 4 DMC

• 1 other identifier: 1039
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

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.

Conditions

Abortion in Second Trimester

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Induction-to-abortion interval

  0 - 48 hours after first misoprostol dose

• Total dose of misoprostol

  0 - 48 hours after first misoprostol dose

• Safety - 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

• Tasks performed by certified staff

  0 - 72 hours after receipt of mifepristone

• Hospital admission time

  Within 0 - 48 hours after the second dose of misoprostol

Study Arms (1)

Mifepristone + Misoprostol

EXPERIMENTAL

Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)

Drug: Mifepristone + Misoprostol

Interventions

Mifepristone + Misoprostol DRUG

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.

Mifepristone + Misoprostol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• CREHPA: collaborator
• Kathmandu Medical College and Teaching Hospital: collaborator
• Kathmandu Model Hospital: collaborator
• KIST Medical College: collaborator

Study Sites (3)

KIST Medical College, Teaching Hospital

Imadol, Lalitpur, Nepal

Location

Kathmandu Medical College

Kathmandu, Nepal

Location

Kathmandu Model Hospital

Kathmandu, Nepal

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Jennifer Blum, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Monica Dragoman, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Chanda Karki, MD

  Kathmandu Medical College

  PRINCIPAL INVESTIGATOR

• Dina Abbas, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Anand Tamang, MPhil

  CREHPA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

NE (3)