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This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
The specific aims of this project are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone-misoprostol | Experimental | Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone and misoprostol | Drug | Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol |
|
| Measure | Description | Time Frame |
|---|---|---|
| successful menstrual regulation without the need for a surgical evacuation | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
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| Name | Affiliation | Role |
|---|---|---|
| Hillary J Bracken, PhD | Gynuity Health Projects | Principal Investigator |
| Laura Reichenbach, PhD | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aminbazar Rural Dispensary | Aminbazar | Dhaka Division | Bangladesh | |||
| MCH-Unit, Upazilla Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29049861 | Derived | Alam A, Lotarevich T, Das TR, Reichenbach L, Bracken H. Mifepristone-misoprostol for menstrual regulation in public sector facilities in Bangladesh. Int J Gynaecol Obstet. 2018 Feb;140(2):205-210. doi: 10.1002/ijgo.12356. Epub 2017 Nov 9. |
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| Savar Upazila |
| Dhaka Division |
| Bangladesh |
| Tetulzhora UH&FWC | Tetuljhora | Dhaka Division | Bangladesh |
| Chartarapur UH & FWC | Chandrapur | Rajshahi Division | Bangladesh |
| Goyeshpur UH &FWC | Goyespur | Rajshahi Division | Bangladesh |
| MCH Unit, Sadar Upazilla | Pābna | Rajshahi Division | Bangladesh |
| Pabna MCWC | Pābna | Rajshahi Division | Bangladesh |
| Mohammadpur Fertility Services and Training Center | Dhaka | Bangladesh |
| 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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