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

NCT05046041 | Completed Phase 4

• 1 other identifier: 1051
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (1)

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

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

  0 - 48 hours after first dose of mifepristone

Secondary Outcomes (9)

• Average induction-to-abortion interval

  0 - 48 hours after first misoprostol dose

• Average number of total doses of misoprostol

  0 - 48 hours after first misoprostol dose

• Frequency of adverse events

  0-2 weeks after initial visit

• Description of tasks performed by different cadres of study staff

  0 - 72 hours after receipt of mifepristone

• Average total hospital admission time

  Within 0 - 48 hours after the second dose of misoprostol

Study Arms (1)

Mifepristone + Misoprostol

EXPERIMENTAL

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

Drug: Mifepristone + Misoprostol

Interventions

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.

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 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

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

Study Sites (2)

Bharatpur Hospital

Bharatpur, Nepal

Location

Lumbini Provincial Hospital

Butwāl, 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

• Inga Platais

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Anand Tamang

  CREHPA

  PRINCIPAL INVESTIGATOR

• Sajan K.C, MD

  Bharatpur Eye Hospital

  PRINCIPAL INVESTIGATOR

• Shreedhar Acharya, MD

  Lumbini Provincial Hospital

  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: July 22, 2021
• First Posted: September 16, 2021
• Study Start: November 25, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

NE (2)