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| Name | Class |
|---|---|
| KIST Medical College and Teaching Hospital | UNKNOWN |
| Center for Research on Environment, Health and Population Activities | OTHER |
| Bharatpur Eye Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone + Misoprostol | Experimental | 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone + Misoprostol | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bharatpur Hospital | Bharatpur | Nepal | ||||
| Lumbini Provincial Hospital |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Lumbini Provincial Hospital |
| UNKNOWN |
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|
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 |
| Butwal |
| Nepal |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |