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NCT Number: NCT01080846

Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.

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Key information

Conditions

Postpartum Hemorrhage Body Temperature Changes Dystocia Female Urogenital Diseases and Pregnancy Complications Heat Stress Disorders Hemorrhage Hyperthermia Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases Uterine Hemorrhage Uterine Inertia Wounds and Injuries

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Gineco Obstetrico Isidro Ayora

Quito, Pichincha, Ecuador

About this study

The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.

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
  • Oxytocin given during 3rd stage of labor

Exclusion criteria

  • Known allergy to prostaglandins or misoprostol
  • Underwent cesarean section
  • Postpartum hemorrhage NOT due to suspected uterine atony
  • Oxytocin NOT given during 3rd stage of labor
  • Severe ill health
  • Unable to give informed consent

Treatment and study plan

Misoprostol

Drug

600 mcg of sublingual misoprostol

Primary outcomes

  1. Rate of fever above 40.0 degrees centigrade

    Time frame: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH

    % 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

    % of women experiencing any shivering and any fever or any other side effect

  2. Acceptability of side effect profile among women

    Time frame: Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)

    % of women who rate side effects as acceptable, neutral, unacceptable, don't know

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • University of Liverpool

Registry information

Official study title

Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 4, 2010
Registry last updated
Nov 11, 2010

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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