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| Name | Class |
|---|---|
| Befelatanana Maternity Centre | UNKNOWN |
| Municipal Clinical Hospital No. 1 | UNKNOWN |
| Kagera Regional Hospital | OTHER |
| Jose Macamo Hospital |
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This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:
In Tanzania and Mozambique:
In Moldova and Madagascar:
In Burkina Faso and Vietnam:
1. 400 mcg of sublingual misoprostol in one dose.
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | treatment with 600mcg oral misoprostol |
|
| 2 | Active Comparator | treatment with 400mcg sublingual misoprostol |
|
| 3 | Active Comparator | treatment with Manual Vacuum Aspiration (MVA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| misoprostol | Drug | comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason | one week after initial treatment with the option of an additional week |
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Inclusion Criteria:
If no ultrasound used:
If ultrasound used:
All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
Willing to provide contact information for purposes of follow-up.
Exclusion Criteria:
Contraindications to the study drug;
Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
Signs of severe infection, defined as at least one of the following of:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de District Sanitaire Dandé | Bobo-Dioulasso | Burkina Faso | ||||
| Hôpital de District Sanitaire de Ziniaré |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23697561 | Derived | Ngoc NT, Shochet T, Blum J, Hai PT, Dung DL, Nhan TT, Winikoff B. Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting. BMC Pregnancy Childbirth. 2013 May 22;13:118. doi: 10.1186/1471-2393-13-118. |
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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 |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| UNKNOWN |
| Tudu hospital | UNKNOWN |
| National OBGYN hospital | UNKNOWN |
| Cuchi General District hospital | UNKNOWN |
| Hôpital de District Sanitaire Dandé | UNKNOWN |
| Hôpital de District Sanitaire de Ziniaré | UNKNOWN |
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|
| MVA | Procedure | comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA) |
|
| Ouagadougou |
| Burkina Faso |
| Befelatanana Maternity Centre | Antananarivo | Madagascar |
| Municipal Clinical Hospital | Chishinau | Moldova |
| Jose Macamo Hospital | Maputo | Mozambique |
| Kagera Regional Hospital | Bukoba | Tanzania |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |