A Phase 4 interventional study of Standard Antibiotic Treatment and No Antibiotic Treatment in Chorioamnionitis, Intrapartum Fever and Intra-amniotic Infection, sponsored by University of Utah. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by University of Utah · Phase 4, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Drug: Standard Antibiotic Treatment
No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Other: No 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
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
Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.
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.
Time frame: Within 2 hours of delivery
Positive blood culture
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.
Time frame: Up to 4 days after birth
Need for NICU admission
Admission of the infant to the Newborn Intensive Care Unit
Time frame: Up to 4 weeks after birth
Newborn length of stay
Days hospitalized after birth
Time frame: Up to 4 weeks after birth
Maternal endometritis
The diagnosis of endometritis made by the patient's OB provider requiring treatment with antibiotics.
Time frame: Up to 4 weeks after birth
Maternal length of stay
Days hospitalized after delivery
Time frame: Up to 4 weeks after birth
Patient satisfaction
Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery
Time frame: 6-8 weeks after delivery
Cost
The hospital charges for mother and infant
Time frame: Up to 4 weeks after birth
Plan to share: No
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Utah