Assessing Outpatient 'Day Procedure' for Second-trimester Medical Abortion at Two Public Sector Hospitals in Nepal
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with method success on the same day as misoprostol initiation. [0 - 48 hours after first dose of mifepristone]
Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day
Secondary Outcome Measures
- Average induction-to-abortion interval [0 - 48 hours after first misoprostol dose]
Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta
- Average number of total doses of misoprostol [0 - 48 hours after first misoprostol dose]
Total misoprostol doses administered from induction to delivery of placenta.
- Frequency of adverse events [0-2 weeks after initial visit]
Adverse events include extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, or prolonged hospitalization, any complications (immediate and delayed)
- Description of tasks performed by different cadres of study staff [0 - 72 hours after receipt of mifepristone]
Tasks evaluated include counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge
- Average total hospital admission time [Within 0 - 48 hours after the second dose of misoprostol]
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
- Average pain scores [0 - 48 hours after first dose of misoprostol]
Severity incidence based on a 0-10 point pain scale
- Frequency of individual side effects experienced by participants [0 - 48 hours after first dose of misoprostol]
Side effects evaluated include diarrhea, nausea, vomiting, fever, chills
- Proportion of reported complications [0-2 weeks after initial visit]
Participants who returned to a health facility for evaluation and management of complications within 2 weeks of taking mifepristone
- Proportion of satisfied participants [2 weeks after initial visit]
Participants who report high satisfaction with service
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have an ongoing pregnancy of 13-18 weeks gestation
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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)
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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
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Be willing to follow study procedures
Exclusion Criteria:
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Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
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Any contraindications to vaginal delivery
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More than one prior cesarean delivery
-
Living more than 2 hours away from the hospital
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bharatpur Hospital | Bharatpur | Nepal | ||
| 2 | Lumbini Provincial Hospital | Butwāl | Nepal |
Sponsors and Collaborators
- Gynuity Health Projects
- KIST Medical College and Teaching Hospital
- Center for Research on Environment Health and Population Activities (CREHPA)
- Bharatpur Eye Hospital
- Lumbini Provincial Hospital
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1051