Intrapartum Fever: Antibiotics Versus no Treatment

University of Utah

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Chorioamnionitis Intrapartum Fever Intra-amniotic Infection

Interventions

Standard Antibiotic TreatmentDRUG

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

No Antibiotic TreatmentOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.

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.

Time frame: Within 2 hours of delivery

Secondary Outcomes

Positive blood culture

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.

Time frame: Up to 4 days after birth

Need for NICU admission

Admission of the infant to the Newborn Intensive Care Unit

Time frame: Up to 4 weeks after birth

Newborn length of stay

Days hospitalized after birth

Time frame: Up to 4 weeks after birth

Maternal endometritis

The diagnosis of endometritis made by the patient's OB provider requiring treatment with antibiotics.

Time frame: Up to 4 weeks after birth

Maternal length of stay

Days hospitalized after delivery

Time frame: Up to 4 weeks after birth

Patient satisfaction

Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery

Data from ClinicalTrials.gov

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