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Difficulties with recruitment, COVID 19 pandemic
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This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D&E will be performed to complete the abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone and misoprostol | Experimental | Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | One 200 mg pill (oral) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful medical abortion | Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction. | 0-60 hours after mifepristone |
| Measure | Description | Time Frame |
|---|---|---|
| Induction-to-abortion interval | Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion | 0-12 hours after misoprostol |
| Initiation-to-abortion interval | Time (median min/hrs) from mifepristone administration until fetal and placental expulsion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilana G Dzuba, MHS | Gynuity Health Projects | Principal Investigator |
| Maria Mercedes Vivas, MD | Fundacion Orientame | Principal Investigator |
| Juliette Ortiz | Fundacion Orientame | Study Director |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Orientame | Bogotá | Colombia |
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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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| Misoprostol |
| Drug |
Two 400 mcg pills (sublingual) |
|
| 0-60 hours after mifepristone |
| Total dose of misoprostol administered | Mean number of misoprostol doses administered to achieve abortion | 0-12 hours after misoprostol |
| Method safety | Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications | Two weeks after mifepristone |
| Tasks performed by clinic staff | Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider | From enrollment through discharge from care (approx. 3 days) |
| Total clinic time | Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day | 0-12 hours from arrival at clinic on day of induction with misoprostol |
| Pain with procedure | Mean pain score (scale 0-10) | 0-12 hours after first misoprostol dose |
| Side effects | Report of side effects and proportion of participants who experienced each one | 0-12 hours after first misoprostol dose |
| Satisfaction with procedure | Proportion of participants who reported the procedure as satisfactory or very satisfactory | Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose |
| 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 |