Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

Gynuity Health Projects

Status and phase: Completed; Phase 3

Conditions: Postpartum Hemorrhage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02163616

3003

Details and patient eligibility

About

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.

Enrollment: 635 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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635 participants in 1 patient group

PPH Treatment

Experimental group

Description:

800mcg sublingual misoprostol

Treatment:

Drug: Misoprostol