Outpatient Service for Mid-trimester Termination of Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Abortion in Second Trimester
• Intervention / Treatment: Drug: Mifepristone + Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nepal
  • Kathmandu, Nepal
    • Kathmandu Medical College
  • Kathmandu, Nepal
    • Kathmandu Model Hospital
  • Lalitpur
    • Imadol, Lalitpur, Nepal
      • KIST Medical College, Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone + Misoprostol; Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total dose of misoprostol	Average number of doses 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	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	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
Hospital admission time	Average total hospital admission time	Within 0 - 48 hours after the second dose of misoprostol
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
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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Kathmandu Medical College and Teaching Hospital; CREHPA; Kathmandu Model Hospital; KIST Medical College
• Investigators: Principal Investigator: Monica Dragoman, MD, MPH, Gynuity Health Projects; Principal Investigator: Chanda Karki, MD, Kathmandu Medical College; Principal Investigator: Anand Tamang, MPhil, CREHPA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No