Intrapartum Fever: Antibiotics Versus no Treatment

Phase 4

Withdrawn

• Conditions: Intrapartum Fever; Chorioamnionitis; Intra-amniotic Infection
• Interventions: Drug: Standard Antibiotic Treatment; Other: No Antibiotic Treatment

• Registration Number: NCT03168178
• Lead Sponsor: University of Utah

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Study Start: 2017-06-08
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-21
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Antibiotic Treatment	Standard Antibiotic Treatment	Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
No Antibiotic Treatment	No Antibiotic Treatment	No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maternal length of stay	Up to 4 weeks after birth	Days hospitalized after delivery
Positive blood culture	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.
Need for NICU admission	Up to 4 weeks after birth	Admission of the infant to the Newborn Intensive Care Unit
Newborn length of stay	Up to 4 weeks after birth	Days hospitalized after birth
Maternal endometritis	Up to 4 weeks after birth	The diagnosis of endometritis made by the patient's OB provider requiring treatment with antibiotics.
Patient satisfaction	6-8 weeks after delivery	Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery
Cost	Up to 4 weeks after birth	The hospital charges for mother and infant

Trial Locations

Locations (1)

University of Utah, Department of Obstetrics & Gynecology; 🇺🇸 Salt Lake City, Utah, United States