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Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

NCT02163616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2017-04-24

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

800 mcg of sublingual misoprostol

Sponsors & Collaborators

  • Centro Rosarino de Estudios Perinatales

    collaborator UNKNOWN

  • University of Liverpool

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Guillermo Carroli, MD · Centro Rosarino de Estudios Perinatales

  • Jill Durocher · Gynuity Health Projects

  • Ilana Dzuba, MPH · Gynuity Health Projects

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • Argentina

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02163616 on ClinicalTrials.gov