Misoprostol
Drug800 mcg of sublingual misoprostol
NCT Number: NCT02163616
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.
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Notify MeFemale
Interventional
Phase 3
Hospital Dr. A. Llano, Corrientes, Argentina
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
800 mcg of sublingual misoprostol
Time frame: First 2 hours postpartum
Percentage of women with body temperature measures ≥40°C
Time frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
Percentage of women experiencing any shivering and any fever or any other side effect
Time frame: Interviewed prior to hospital discharge (about 24 hours postpartum)
Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
Time frame: First hour of the puerperium
Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
Time frame: sample taken 24-48 hours postpartum
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.
Gynuity Health Projects
Other
Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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