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

Abortion in Second Trimester Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046041
• Other study ID #: 1051
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion in Second Trimester

Intervention

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.

Locations

Country	Name	City	State
Nepal	Bharatpur Hospital	Bharatpur
Nepal	Lumbini Provincial Hospital	Butwal

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Bharatpur Eye Hospital, Center for Research on Environment Health and Population Activities (CREHPA), KIST Medical College and Teaching Hospital, Lumbini Provincial Hospital

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Average number of total doses of misoprostol	Total misoprostol doses administered from induction to delivery of placenta.	0 - 48 hours after first misoprostol dose
Secondary	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
Secondary	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
Secondary	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
Secondary	Average pain scores	Severity incidence based on a 0-10 point pain scale	0 - 48 hours after first dose of misoprostol
Secondary	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
Secondary	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
Secondary	Proportion of satisfied participants	Participants who report high satisfaction with service	2 weeks after initial visit