Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give informed consent Vaginal delivery Postpartum hemorrhage due to suspected uterine atony Oxytocin given during 3rd stage of labor Exclusion Criteria: Known allergy to prostaglandins or misoprostol Underwent cesarean section Postpartum hemorrhage NOT due to suspected uterine atony Oxytocin NOT given during 3rd stage of labor Severe ill health Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 600 mcg of sublingual misoprostol<br> | Drug: Misoprostol<br>* 600 mcg of sublingual misoprostol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | % 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia