NCT01080846

Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Misoprostol	600 mcg of sublingual misoprostol

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-03-04
• Last updated: 2010-11-11

Locations

1 site across 1 country: Ecuador