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Completed

NCT Number: NCT02163616

Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

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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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

800 mcg of sublingual misoprostol

Primary outcomes

  1. Rates of high fever (≥40.0°C)

    Time frame: First 2 hours postpartum

    Percentage of women with body temperature measures ≥40°C

Secondary outcomes

  1. Side effect profile of misoprostol for PPH treatment

    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

  2. Acceptability of regimen and side effects to women

    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

  3. Shock index values

    Time frame: First hour of the puerperium

    Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)

  4. Genetic factors responsible for elevated body temperature

    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.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Centro Rosarino de Estudios Perinatales
  • University of Liverpool

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2014
Registry last updated
Apr 24, 2017

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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