Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163616
• Other study ID #: 3003
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2014
• Last updated: April 20, 2017
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2017
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
800 mcg of sublingual misoprostol

Locations

Country	Name	City	State
Argentina	Hospital Dr. A. Llano	Corrientes
Argentina	Hospital J.R. Vidal	Corrientes

Sponsors (3)

Lead Sponsor	Collaborator
Gynuity Health Projects	Centro Rosarino de Estudios Perinatales, University of Liverpool

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of high fever (=40.0°C)	Percentage of women with body temperature measures =40°C	First 2 hours postpartum
Secondary	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
Secondary	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)
Secondary	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
Secondary	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

External Links

•   Gynuity Health Projects