Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

Phase 3

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Misoprostol

• Registration Number: NCT02163616
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Study Start: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 635

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPH Treatment	Misoprostol	800mcg sublingual misoprostol

Primary Outcome Measures

Name	Time	Method
Rates of high fever (≥40.0°C)	First 2 hours postpartum	Percentage of women with body temperature measures ≥40°C

Secondary Outcome Measures

Name	Time	Method
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
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.
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
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)

Trial Locations

Locations (2)

Hospital Dr. A. Llano; 🇦🇷 Corrientes, Argentina

Hospital J.R. Vidal; 🇦🇷 Corrientes, Argentina