Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

NCT02163616 | Completed Phase 3

• 1 other identifier: 3003
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Keywords

Primary postpartum hemorrhage; PPH; uterine atony; high fever; hyperpyrexia; shock index

Outcome Measures

Primary Outcomes (1)

• Rates of high fever (≥40.0°C)

  Percentage of women with body temperature measures ≥40°C

  First 2 hours postpartum

Secondary Outcomes (4)

• Side effect profile of misoprostol for PPH treatment

  Side effects observed for 3 hours post-treatment with misoprostol for PPH

• Acceptability of regimen and side effects to women

  Interviewed prior to hospital discharge (about 24 hours postpartum)

• Shock index values

  First hour of the puerperium

• Genetic factors responsible for elevated body temperature

  sample taken 24-48 hours postpartum

Study Arms (1)

PPH Treatment

EXPERIMENTAL

800mcg sublingual misoprostol

Drug: Misoprostol

Interventions

Misoprostol DRUG

800 mcg of sublingual misoprostol

PPH Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give informed consent
• Vaginal delivery
• Postpartum hemorrhage due to suspected uterine atony
• Able and willing to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Centro Rosarino de Estudios Perinatales: collaborator
• University of Liverpool: collaborator

Study Sites (2)

Hospital Dr. A. Llano

Corrientes, Argentina

Location

Hospital J.R. Vidal

Corrientes, Argentina

Location

Related Links

• Gynuity Health Projects

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia; Hyperthermia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Guillermo Carroli, MD

  Centro Rosarino de Estudios Perinatales

  PRINCIPAL INVESTIGATOR

• Jill Durocher

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Ilana Dzuba, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 13, 2014
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

AR (2)