Clinical trial NCT03168178: Intrapartum Fever: Antibiotics Versus no Treatment
Official title: A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chorioamnionitis
Intrapartum Fever
Intra-amniotic Infection
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Low risk women will be randomized to standard antibiotic treatment versus no antiobiotics.
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.
timeFrame: Within 2 hours of delivery
Secondary outcomes:
measure: Positive blood culture
timeFrame: Up to 4 days after birth
measure: Need for NICU admission
timeFrame: Up to 4 weeks after birth
measure: Newborn length of stay
timeFrame: Up to 4 weeks after birth
measure: Maternal endometritis
timeFrame: Up to 4 weeks after birth
measure: Maternal length of stay
timeFrame: Up to 4 weeks after birth
measure: Patient satisfaction
timeFrame: 6-8 weeks after delivery
measure: Cost
timeFrame: Up to 4 weeks after birth
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, Department of Obstetrics & Gynecology
state: Utah
Study officials:
affiliation: University of Utah
name: Heather Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Evers AC, Nijhuis L, Koster MP, Bont LJ, Visser GH. Intrapartum fever at term: diagnostic markers to individualize the risk of fetal infection: a review. Obstet Gynecol Surv. 2012 Mar;67(3):187-200. doi: 10.1097/OGX.0b013e31824bb5f1.
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citation: Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.
citation: Newman TB, Puopolo KM, Wi S, Draper D, Escobar GJ. Interpreting complete blood counts soon after birth in newborns at risk for sepsis. Pediatrics. 2010 Nov;126(5):903-9. doi: 10.1542/peds.2010-0935. Epub 2010 Oct 25.