Overview

This trial is active, not recruiting.

Condition postpartum hemorrhage
Treatment misoprostol
Phase phase 3
Sponsor Gynuity Health Projects
Collaborator Centro Rosarino de Estudios Perinatales
Start date September 2015
End date November 2017
Trial size 1400 participants
Trial identifier NCT02163616, 3003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
800mcg sublingual misoprostol
misoprostol
800 mcg of sublingual misoprostol

Primary Outcomes

Measure
Rates of high fever (≥40.0°C)
time frame: First 2 hours postpartum

Secondary Outcomes

Measure
Side effect profile of misoprostol for PPH treatment
time frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
Acceptability of regimen and side effects to women
time frame: Interviewed prior to hospital discharge (about 24 hours postpartum)
Shock index values
time frame: First hour of the puerperium
Genetic factors responsible for elevated body temperature
time frame: sample taken 24-48 hours postpartum

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
Principal investigator Beverly Winikoff, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Gynuity Health Projects.