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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
635
800 mcg of sublingual misoprostol
Hospital Dr. A. Llano
Corrientes, Argentina
Hospital J.R. Vidal
Corrientes, Argentina
Rates of high fever (≥40.0°C)
Percentage of women with body temperature measures ≥40°C
Time frame: First 2 hours postpartum
Side effect profile of misoprostol for PPH treatment
Percentage of women experiencing any shivering and any fever or any other side effect
Time frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
Acceptability of regimen and side effects to women
Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
Time frame: Interviewed prior to hospital discharge (about 24 hours postpartum)
Shock index values
Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
Time frame: First hour of the puerperium
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.
Time frame: sample taken 24-48 hours postpartum
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