Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PPH Treatment

800mcg sublingual misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

800 mcg of sublingual misoprostol

Interventions

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Misoprostol

800 mcg of sublingual misoprostol

Intervention Type DRUG

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes