NCT02163616

Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Misoprostol	800 mcg of sublingual misoprostol

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2014-06-13
• Last updated: 2017-04-24

Locations

2 sites across 1 country: Argentina