A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)
Overview
- Phase
- Phase 4
- Intervention
- Standard Antibiotic Treatment
- Conditions
- Chorioamnionitis
- Sponsor
- University of Utah
- Locations
- 1
- Primary Endpoint
- Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Heather Campbell
Principal Investigator
University of Utah
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)
Arms & Interventions
Standard Antibiotic Treatment
Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Intervention: Standard Antibiotic Treatment
No Antibiotic Treatment
No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Intervention: No Antibiotic Treatment
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Maternal length of stay(Up to 4 weeks after birth)
- Positive blood culture(Up to 4 days after birth)
- Need for NICU admission(Up to 4 weeks after birth)
- Newborn length of stay(Up to 4 weeks after birth)
- Maternal endometritis(Up to 4 weeks after birth)
- Patient satisfaction(6-8 weeks after delivery)
- Cost(Up to 4 weeks after birth)