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| Name | Class |
|---|---|
| University of Witwatersrand, South Africa | OTHER |
| Effective Care Research Unit | OTHER |
| Family Care International | OTHER |
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | placebo resembling misoprostol |
|
| 2 | Experimental | misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| misoprostol | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss =>500 mls within one hour after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss =>1000 mls within one hour after enrollment | ||
| Mean blood loss after enrollment | ||
| Blood transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindeka Mangesi | Effective Care Research Unit, East London Hospital Complex, South Africa | Study Director |
| G. J. Hofmeyr, MD | Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital | Ibadan | Nigeria | ||||
| Tembisa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21130990 | Derived | Hofmeyr GJ, Fawole B, Mugerwa K, Godi NP, Blignaut Q, Mangesi L, Singata M, Brady L, Blum J. Administration of 400 mug of misoprostol to augment routine active management of the third stage of labor. Int J Gynaecol Obstet. 2011 Feb;112(2):98-102. doi: 10.1016/j.ijgo.2010.08.019. Epub 2010 Dec 4. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| 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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placebo resembling misoprosotl |
|
| Hemoglobin level <8 g/dL 24 hours after delivery |
| Maternal morbidity and mortality |
| Side effects |
| Johannesburg |
| South Africa |
| Rob Ferreira Hospital | Mbombela | South Africa |
| Dora Nginza Hospital | Port Elizabeth | South Africa |
| Mulago Hospital | Kampala | Uganda |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |