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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| University of Liverpool | OTHER |
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This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.
The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 mcg of sublingual misoprostol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 600 mcg of sublingual misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of fever above 40.0 degrees centigrade | % of women with body temperature measures ≥40°C | Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect profile of misoprostol for PPH treatment | % 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 side effect profile among 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 |
| Andrew Weeks, MD | The University of Liverpool | Principal Investigator |
| Wilfrido Leon, MD | HOSPITAL GINECO OBSTETRICO ISIDRO AYORA | Principal Investigator |
| Gustavo Barrera, MD | HOSPITAL GINECO OBSTETRICO ISIDRO AYORA | Principal Investigator |
| Jill Durocher | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gineco Obstetrico Isidro Ayora | Quito | Pichincha | Ecuador |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20060161 | Background | Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6. | |
| 20060162 |
| 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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% of women who rate side effects as acceptable, neutral, unacceptable, don't know |
| Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum) |
| Background |
| Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6. |
| 22769055 | Derived | Leon W, Durocher J, Barrera G, Pinto E, Winikoff B. Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make? BMC Pregnancy Childbirth. 2012 Jul 7;12:65. doi: 10.1186/1471-2393-12-65. |
| 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 |