Clinical trial NCT05046041: Assessing Outpatient 'Day Procedure' for Second-trimester Medical Abortion at Two Public Sector Hospitals in Nepal
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion in Second Trimester
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: KIST Medical College and Teaching Hospital
name: Center for Research on Environment, Health and Population Activities
name: Bharatpur Eye Hospital
name: Lumbini Provincial Hospital
First posted: 2021-09-16
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with method success on the same day as misoprostol initiation.
timeFrame: 0 - 48 hours after first dose of mifepristone
Secondary outcomes:
measure: Average induction-to-abortion interval
timeFrame: 0 - 48 hours after first misoprostol dose
measure: Average number of total doses of misoprostol
timeFrame: 0 - 48 hours after first misoprostol dose
measure: Frequency of adverse events
timeFrame: 0-2 weeks after initial visit
measure: Description of tasks performed by different cadres of study staff
timeFrame: 0 - 72 hours after receipt of mifepristone
measure: Average total hospital admission time
timeFrame: Within 0 - 48 hours after the second dose of misoprostol
measure: Average pain scores
timeFrame: 0 - 48 hours after first dose of misoprostol
measure: Frequency of individual side effects experienced by participants
timeFrame: 0 - 48 hours after first dose of misoprostol
measure: Proportion of reported complications
timeFrame: 0-2 weeks after initial visit
measure: Proportion of satisfied participants
timeFrame: 2 weeks after initial visit
Other outcomes:
Locations:
city: Bharatpur
country: Nepal
facility: Bharatpur Hospital
city: Butwāl
country: Nepal
facility: Lumbini Provincial Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Inga Platais
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff
role: PRINCIPAL_INVESTIGATOR
affiliation: CREHPA
name: Anand Tamang
role: PRINCIPAL_INVESTIGATOR
affiliation: Bharatpur Eye Hospital
name: Sajan K.C, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lumbini Provincial Hospital
name: Shreedhar Acharya, MD
role: PRINCIPAL_INVESTIGATOR
References: