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

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Abortion in Second Trimester

Treatments: Drug: Mifepristone + Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05046041

1051

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Mifepristone + Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Mifepristone + Misoprostol