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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nepal
  • Bharatpur, Nepal
    • Bharatpur Hospital
  • Butwāl, Nepal
    • Lumbini Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Have an ongoing pregnancy of 13-18 weeks gestation
2. 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)
3. 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
4. Be willing to follow study procedures

Exclusion Criteria:

1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
2. Any contraindications to vaginal delivery
3. More than one prior cesarean delivery
4. Living more than 2 hours away from the hospital

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average induction-to-abortion interval	Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta	0 - 48 hours after first misoprostol dose
Average number of total doses of misoprostol	Total misoprostol doses administered from induction to delivery of placenta.	0 - 48 hours after first misoprostol dose
Frequency of adverse events	Adverse events include extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, or prolonged hospitalization, any complications (immediate and delayed)	0-2 weeks after initial visit
Description of tasks performed by different cadres of study staff	Tasks evaluated include counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge	0 - 72 hours after receipt of mifepristone
Average total hospital admission time	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	Within 0 - 48 hours after the second dose of misoprostol
Average pain scores	Severity incidence based on a 0-10 point pain scale	0 - 48 hours after first dose of misoprostol
Frequency of individual side effects experienced by participants	Side effects evaluated include diarrhea, nausea, vomiting, fever, chills	0 - 48 hours after first dose of misoprostol
Proportion of reported complications	Participants who returned to a health facility for evaluation and management of complications within 2 weeks of taking mifepristone	0-2 weeks after initial visit
Proportion of satisfied participants	Participants who report high satisfaction with service	2 weeks after initial visit

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Bharatpur Eye Hospital; KIST Medical College and Teaching Hospital; Center for Research on Environment Health and Population Activities (CREHPA); Lumbini Provincial Hospital
• Investigators: Principal Investigator: Inga Platais, 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2020
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (ACTUAL): September 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

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: 1051

Drug and device information, study documents

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