Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01080846

2.4.6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

600 mcg of sublingual misoprostol

Experimental group

Treatment:

Drug: Misoprostol