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| Name | Class |
|---|---|
| Centro Rosarino de Estudios Perinatales | UNKNOWN |
| University of Liverpool | OTHER |
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This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding. Blood samples will be collected among women treated with misoprostol to investigate genetic factors responsible for elevated body temperature induced by misoprostol.
The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol treatment (800mcg given sublingually) will be variable across settings. The investigators expect that the side effect profile following 800 mcg misoprostol given sublingually, in particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous results using misoprostol for PPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPH Treatment | Experimental | 800mcg sublingual misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 800 mcg of sublingual misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of high fever (≥40.0°C) | Percentage of women with body temperature measures ≥40°C | First 2 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect profile of misoprostol for PPH treatment | Percentage of women experiencing any shivering and any fever or any other side effect | Side effects observed for 3 hours post-treatment with misoprostol for PPH |
| Acceptability of regimen and side effects to women |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Guillermo Carroli, MD | Centro Rosarino de Estudios Perinatales | Principal Investigator |
| Jill Durocher | Gynuity Health Projects | Principal Investigator |
| Ilana Dzuba, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dr. A. Llano | Corrientes | Argentina | ||||
| Hospital J.R. Vidal |
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| Label | URL |
|---|---|
| Gynuity Health Projects | View source |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D014593 | Uterine Inertia |
| D000084462 | Hyperthermia |
| 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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Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know |
| Interviewed prior to hospital discharge (about 24 hours postpartum) |
| Shock index values | Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes) | First hour of the puerperium |
| Genetic factors responsible for elevated body temperature | Blood samples will be collected among women enrolled and sent to the Wolfson centre for personalized medicine at the University of Liverpool for genetic analysis to investigate genetic markers associated with misoprostol-induced fever. | sample taken 24-48 hours postpartum |
| Corrientes |
| Argentina |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004420 | Dystocia |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |