Intrapartum Fever: Antibiotics Versus no Treatment

NCT ID: NCT03168178

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-08
• Study Completion Date: 2018-07-26

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.

Conditions

Chorioamnionitis; Intrapartum Fever; Intra-amniotic Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard Antibiotic Treatment

Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.

Group Type: ACTIVE_COMPARATOR

Standard Antibiotic Treatment

Intervention Type: DRUG

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 Treatment

No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.

Group Type: EXPERIMENTAL

No Antibiotic Treatment

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Heather Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 12548228 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

91955

Identifier Type: -

Identifier Source: org_study_id