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| Name | Class |
|---|---|
| La Rabta Maternity Hospital | UNKNOWN |
| Republican Institute of RH, Perinatology, and Ob/Gyn | UNKNOWN |
| Kathmandu Medical College and Teaching Hospital | OTHER |
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The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual misoprostol | Active Comparator | 200mg mifepristone + 400mcg sublingual misoprostol q3h |
|
| Buccal misoprostol | Active Comparator | 200mg mifepristone + 400mcg buccal misoprostol q3h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | 200mg oral mifepristone to both study arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful abortion by 24 hours | Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention. | 24 hours following the start of misoprostol |
| Rate of successful abortion by 48 hours | Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention. | 48hours following the start of misoprostol |
| Measure | Description | Time Frame |
|---|---|---|
| Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta). | 48 hours | |
| Percentage of patients requiring provision of additional interventions. | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG) | Recruiting | Yerevan | Armenia |
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| Clinic No. 2 of Tashkent Medical Academy |
| UNKNOWN |
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| Buccal misoprostol | Drug | doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone |
|
|
| Sublingual misoprostol | Drug | doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone |
|
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| Total number of doses of misoprostol. | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
| Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment | 1 month |
| Pain scale (1-7) as reported by women on questionnaire | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
| Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
| Kathmandu Medical College | Recruiting | Kathmandu | Nepal |
|
| La Rabta Maternity Hospital | Recruiting | Tunis | Tunisia |
|
| Clinic No. 2, Tashkent Medical Academy | Recruiting | Tashkent | Uzbekistan |
|
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| 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 |
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