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

NCT05046041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-16

No results posted yet for this study

Summary

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.

Conditions

  • Abortion in Second Trimester

Interventions

DRUG

Mifepristone + Misoprostol

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.

Sponsors & Collaborators

  • KIST Medical College and Teaching Hospital

    collaborator UNKNOWN

  • Center for Research on Environment, Health and Population Activities

    collaborator OTHER

  • Bharatpur Eye Hospital

    collaborator OTHER

  • Lumbini Provincial Hospital

    collaborator UNKNOWN

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Inga Platais · Gynuity Health Projects

  • Beverly Winikoff · Gynuity Health Projects

  • Anand Tamang · CREHPA

  • Sajan K.C, MD · Bharatpur Eye Hospital

  • Shreedhar Acharya, MD · Lumbini Provincial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046041 on ClinicalTrials.gov