Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?

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 Able and willing to give informed consent Exclusion Criteria: Known allergy to misoprostol or other prostaglandins Underwent a c-section during the current delivery Unable to provide informed consent due to mental impairment, distress during labor or other reason Unwilling and/or unable to respond to brief questionnaires or have her blood drawn
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: PPH Treatment<br>800mcg sublingual misoprostol | Drug: Misoprostol<br>* 800 mcg of sublingual misoprostol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of high fever (≥40.0°C) | Percentage of women with body temperature measures ≥40°C | First 2 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 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, shock index