Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 635
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Corrientes, Argentina
    • Hospital Dr. A. Llano
  • Corrientes, Argentina
    • Hospital J.R. Vidal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPH Treatment; 800mcg sublingual misoprostol	Drug: Misoprostol; 800 mcg of sublingual misoprostol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: University of Liverpool; Centro Rosarino de Estudios Perinatales
• Investigators: Principal Investigator: Jill Durocher, Gynuity Health Projects; Principal Investigator: Ilana Dzuba, MPH, Gynuity Health Projects; Principal Investigator: Guillermo Carroli, MD, Centro Rosarino de Estudios Perinatales

Publications and helpful links

Helpful Links

• Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: uterine atony; PPH; Primary postpartum hemorrhage; high fever; hyperpyrexia; shock index
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 3003