Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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Abstract

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.

Dates

Last Verified:	03/31/2017
First Submitted:	06/05/2014
Estimated Enrollment Submitted:	06/10/2014
First Posted:	06/12/2014
Last Update Submitted:	04/19/2017
Last Update Posted:	04/23/2017
Actual Study Start Date:	08/31/2015
Estimated Primary Completion Date:	04/30/2016
Estimated Study Completion Date:	05/31/2016

Condition or disease

Postpartum Hemorrhage

Intervention/treatment

Drug: PPH Treatment

Phase

Phase 3

Arm Groups

Arm	Intervention/treatment
Experimental: PPH Treatment 800mcg sublingual misoprostol	Drug: PPH Treatment 800 mcg of sublingual misoprostol

Eligibility Criteria

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Criteria

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

Outcome

Primary Outcome Measures

1. Rates of high fever (≥40.0°C) [First 2 hours postpartum]

Percentage of women with body temperature measures ≥40°C

Secondary Outcome Measures

1. Side effect profile of misoprostol for PPH treatment [Side effects observed for 3 hours post-treatment with misoprostol for PPH]

Percentage of women experiencing any shivering and any fever or any other side effect

2. Acceptability of regimen and side effects to women [Interviewed prior to hospital discharge (about 24 hours postpartum)]

Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know

3. Shock index values [First hour of the puerperium]

Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)

4. Genetic factors responsible for elevated body temperature [sample taken 24-48 hours postpartum]

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.