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Completed

NCT Number: NCT05046041

Assessing Outpatient 'Day Procedure' for Second-trimester Medical Abortion at Two Public Sector Hospitals in Nepal

This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation in two public sector facilities. It also seeks to document the roles of health workers in providing services related to later abortion care and to document the costs of this day procedure to the health system.

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Key information

Conditions

Abortion in Second Trimester

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bharatpur Hospital, Bharatpur, 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 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)
  • Have access to a phone where she can be reached at the 2-week follow up or willing to return to the clinic for an in-person interview with the research assistant
  • 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 200 mg mifepristone (one tablet) 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 (buccal) every three hours until the abortion is achieved.

Primary outcomes

  1. Proportion of participants with method success on the same day as misoprostol initiation.

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

    Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day

Secondary outcomes

  1. Average induction-to-abortion interval

    Time frame: 0 - 48 hours after first misoprostol dose

    Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta

  2. Average number of total doses of misoprostol

    Time frame: 0 - 48 hours after first misoprostol dose

    Total misoprostol doses administered from induction to delivery of placenta.

  3. Frequency of adverse events

    Time frame: 0-2 weeks after initial visit

    Adverse events include extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, or prolonged hospitalization, any complications (immediate and delayed)

  4. Description of tasks performed by different cadres of study staff

    Time frame: 0 - 72 hours after receipt of mifepristone

    Tasks evaluated include counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge

  5. Average total hospital admission time

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

    Total hospital admission time, including: 1) total admission time during treatment with misoprostol and abortion recovery 2) Additional hospital time required for the evaluation and management of complications

  6. Average pain scores

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

    Severity incidence based on a 0-10 point pain scale

  7. Frequency of individual side effects experienced by participants

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

    Side effects evaluated include diarrhea, nausea, vomiting, fever, chills

  8. Proportion of reported complications

    Time frame: 0-2 weeks after initial visit

    Participants who returned to a health facility for evaluation and management of complications within 2 weeks of taking mifepristone

  9. Proportion of satisfied participants

    Time frame: 2 weeks after initial visit

    Participants who report high satisfaction with service

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Bharatpur Eye Hospital
  • Center for Research on Environment, Health and Population Activities
  • KIST Medical College and Teaching Hospital
  • Lumbini Provincial Hospital

Registry information

Official study title

A Study of Acceptability and Feasibility of an Outpatient "Day Procedure" for Medical Abortion at 13-18 Weeks Gestation in Two Public Sector Hospitals in Nepal

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

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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