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| Name | Class |
|---|---|
| CREHPA | UNKNOWN |
| Kathmandu Medical College and Teaching Hospital | OTHER |
| Kathmandu Model Hospital | UNKNOWN |
| KIST Medical College |
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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. The study regimen will consist of a single dose of 200 mg mifepristone 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 every three hours until the abortion is achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone + Misoprostol | Experimental | Intervention: 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 dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful medical abortion | Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction | 0 - 48 hours after first dose of mifepristone |
| Measure | Description | Time Frame |
|---|---|---|
| Induction-to-abortion interval | Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta | 0 - 48 hours after first misoprostol dose |
| Total dose of misoprostol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Blum, MPH | Gynuity Health Projects | Principal Investigator |
| Monica Dragoman, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Chanda Karki, MD | Kathmandu Medical College | Principal Investigator |
| Dina Abbas, MPH | Gynuity Health Projects | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Anand Tamang, MPhil | CREHPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KIST Medical College, Teaching Hospital | Imadol | Lalitpur | Nepal | |||
| Kathmandu Medical College |
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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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| UNKNOWN |
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Average number of doses of misoprostol
| 0 - 48 hours after first misoprostol dose |
| Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications | Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications | 2 weeks after initial visit |
| Tasks performed by certified staff | Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) | 0 - 72 hours after receipt of mifepristone |
| Hospital admission time | Average total hospital admission time | Within 0 - 48 hours after the second dose of misoprostol |
| Side Effects | Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale) | 0 - 48 hours after first dose of misoprostol |
| Initiation-to-abortion interval | Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta | 0 - 72 hours after receipt of mifepristone |
| Kathmandu |
| Nepal |
| Kathmandu Model Hospital | Kathmandu | 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 |