Clinical trial NCT02163616: Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
Official title: Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Keywords: Primary postpartum hemorrhage
PPH
uterine atony
high fever
hyperpyrexia
shock index
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Centro Rosarino de Estudios Perinatales
name: University of Liverpool
First posted: 2014-06-13
Enrollment: 635
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rates of high fever (≥40.0°C)
timeFrame: First 2 hours postpartum
Secondary outcomes:
measure: Side effect profile of misoprostol for PPH treatment
timeFrame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
measure: Acceptability of regimen and side effects to women
timeFrame: Interviewed prior to hospital discharge (about 24 hours postpartum)
measure: Shock index values
timeFrame: First hour of the puerperium
measure: Genetic factors responsible for elevated body temperature
timeFrame: sample taken 24-48 hours postpartum
Other outcomes:
Locations:
city: Corrientes
country: Argentina
facility: Hospital Dr. A. Llano
city: Corrientes
country: Argentina
facility: Hospital J.R. Vidal
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Rosarino de Estudios Perinatales
name: Guillermo Carroli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MPH
role: PRINCIPAL_INVESTIGATOR
References: