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In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Active Comparator | standard surgical treatment (either dilation and curettage or manual vacuum aspiration) |
|
| misoprostol | Active Comparator | 400 mcg misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| misoprostol | Drug | single dose of 400 mcg misoprostol administered sublingually |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete abortion without recourse to surgical intervention. | follow up visit 7 days after initial treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Rasha Dabash, MPH | Gynuity Health Projects | Study Director |
| Ayisha Diop, MPH | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dandé District Hospital/Ziniaré District Hospital | Dande/Ziniare | Burkina Faso | ||||
| El-Galaa Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34061352 | Derived | Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2. | |
| 23150927 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000027 | Abortion, Incomplete |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| surgery |
| Procedure |
standard surgical treatment (dilation and curettage or manual vacuum aspiration) |
|
| Cairo |
| Egypt |
| Shatby Maternity Hospital/Alexandria University | Shatby, Alexandria | Egypt |
| Cheikh Zayed Hospital | Nouakchott | Mauritania |
| Maternite Issaka Gazobi | Niamey | Niger |
| Centre de Sante Le Roi Baudouin | Guédiawaye | Senegal |
| Shochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127. |
| 22935621 | Derived | Blandine T, Ouattara AZ, Coral A, Hassane C, Clotaire H, Dao B, Lankoande J, Diop A, Blum J. Sublingual [corrected] misoprostol as first-line care for incomplete abortion in Burkina Faso. Int J Gynaecol Obstet. 2012 Nov;119(2):166-9. doi: 10.1016/j.ijgo.2012.05.036. Epub 2012 Aug 28. |
| 20801444 | Derived | Dabash R, Ramadan MC, Darwish E, Hassanein N, Blum J, Winikoff B. A randomized controlled trial of 400-mug sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. Int J Gynaecol Obstet. 2010 Nov;111(2):131-5. doi: 10.1016/j.ijgo.2010.06.021. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |