Intrapartum Fever: Antibiotics Versus no Treatment

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 4

Conditions: Intra-amniotic Infection; Chorioamnionitis; Intrapartum Fever

Treatments: Other: No Antibiotic Treatment; Drug: Standard Antibiotic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03168178

91955

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Antibiotic Treatment

Active Comparator group

Description:

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

Treatment:

Drug: Standard Antibiotic Treatment

No Antibiotic Treatment

Experimental group

Description:

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

Treatment:

Other: No Antibiotic Treatment