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Completed

NCT Number: NCT03346629

Outpatient Service for Mid-trimester Termination of Pregnancy

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.

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Key information

Conditions

Abortion in Second Trimester

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

KIST Medical College, Teaching Hospital, Imadol, Lalitpur, Nepal

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Successful medical abortion

    Time frame: 0 - 48 hours after first dose of mifepristone

    Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction

Secondary outcomes

  1. Induction-to-abortion interval

    Time frame: 0 - 48 hours after first misoprostol dose

    Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta

  2. Total dose of misoprostol

    Time frame: 0 - 48 hours after first misoprostol dose

    Average number of doses of misoprostol

  3. Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications

    Time frame: 2 weeks after initial visit

    Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications

  4. Tasks performed by certified staff

    Time frame: 0 - 72 hours after receipt of mifepristone

    Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge)

  5. Hospital admission time

    Time frame: Within 0 - 48 hours after the second dose of misoprostol

    Average total hospital admission time

  6. Side Effects

    Time frame: 0 - 48 hours after first dose of misoprostol

    Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale)

  7. Initiation-to-abortion interval

    Time frame: 0 - 72 hours after receipt of mifepristone

    Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • CREHPA
  • KIST Medical College
  • Kathmandu Medical College and Teaching Hospital
  • Kathmandu Model Hospital

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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