Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Gynuity Health Projects
Collaborators:
Centro Rosarino de Estudios Perinatales Fundación Valle del Lili University of Liverpool