Intrapartum Fever: Antibiotics Versus no Treatment

October 21, 2018 updated by: Heather Campbell, University of Utah

A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)

The purpose of this study is to determine whether antibiotics can be safely avoided in women who develop a fever during labor. Because investigators have no accurate tests to determine whether women who develop fever during labor have intra-amniotic infection, antibiotics are often used to prevent spread of infection to the fetus.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A fever > 100.4 F during labor (intrapartum fever) complicates up to 14% of term deliveries, and is commonly considered a sign of intrauterine infection. Despite studies showing that most causes of maternal intrapartum fever are non-infectious, intrapartum fever often prompts the diagnosis of chorioamnionitis/intrauterine infection, or what is now known as 'triple I' (intra-amniotic infection or inflammation). Diagnosis of triple I is primarily based on clinical findings such as maternal fever, maternal leukocytosis, uterine tenderness, foul-smelling or purulent amniotic fluid, and fetal tachycardia. A minimum of two of these criteria for diagnosis, although this distinction is somewhat artificial as fetal tachycardia is highly associated with maternal fever. The poor performance of clinical signs and lack of effective biomarkers to identify neonatal infection results in over treatment of both mothers and infants.

Avoiding antibiotic use in mothers and infants is desirable in order to avoid unnecessary separation after birth, decreasing cost and interventions in newborns, and to avoid altering the infant's microbiome (the bacteria newborns carry on their skin, mucosal membranes, and in their gut at the time of birth). Infants with altered microbiomes may be at risk for skin, pulmonary, and gastrointestinal disorders. The investigators in this trial are randomizing women with fever during labor who are felt to be a low risk for true infection to antibiotic treatment compared to no antibiotics in order to determine if antibiotics can be safely avoided for these women and their infants.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, Department of Obstetrics & Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women between 34-42 weeks gestation
  • Singleton fetus
  • Admitted for labor management & develops a fever of 100.4 F or greater

Exclusion Criteria:

  • Known fetal anomaly
  • Other indication for intrapartum antibiotics (endocarditis prophylaxis, other known maternal infection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Antibiotic Treatment
Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Drug: Standard Antibiotic Treatment

Participants randomized to this intervention will receive standard antibiotic treatment.

The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes
Experimental: No Antibiotic Treatment
No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Other: No Antibiotic Treatment
Participant randomized to this arm of the study will not receive antibiotics. The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.
Time Frame: Within 2 hours of delivery
All newborns will have a screening assessment including physical exam and vital signs, and this data along with maternal and delivery data is entered into the Kaiser Permanente Early Onset Neonatal Sepsis (EONS) calculator. The EONS calculator estimates the risk of sepsis and recommends observation, additional evaluation, or empiric antibiotic treatment.
Within 2 hours of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive blood culture
Time Frame: Up to 4 days after birth
For infants who have a blood culture obtained by recommendation of the EONS calculator, the presence of significant bacterial growth will be considered a positive culture.
Up to 4 days after birth
Need for NICU admission
Time Frame: Up to 4 weeks after birth
Admission of the infant to the Newborn Intensive Care Unit
Up to 4 weeks after birth
Newborn length of stay
Time Frame: Up to 4 weeks after birth
Days hospitalized after birth
Up to 4 weeks after birth
Maternal endometritis
Time Frame: Up to 4 weeks after birth
The diagnosis of endometritis made by the patient's OB provider requiring treatment with antibiotics.
Up to 4 weeks after birth
Maternal length of stay
Time Frame: Up to 4 weeks after birth
Days hospitalized after delivery
Up to 4 weeks after birth
Patient satisfaction
Time Frame: 6-8 weeks after delivery
Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery
6-8 weeks after delivery
Cost
Time Frame: Up to 4 weeks after birth
The hospital charges for mother and infant
Up to 4 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Heather Campbell, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

July 26, 2018

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 21, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91955

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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