Chorioamnionitis, Intrapartum Fever, Intra-amniotic Infection
Conditions
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.
Interventions
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
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Low risk women will be randomized to standard antibiotic treatment versus no antiobiotics.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator. | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost | Up to 4 weeks after birth | The hospital charges for mother and infant |
| Positive blood culture | Up to 4 days after birth | 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. |
| Need for NICU admission | Up to 4 weeks after birth | Admission of the infant to the Newborn Intensive Care Unit |
| Patient satisfaction | 6-8 weeks after delivery | Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery |
| Maternal endometritis | Up to 4 weeks after birth | The diagnosis of endometritis made by the patient's OB provider requiring treatment with antibiotics. |
| Maternal length of stay | Up to 4 weeks after birth | Days hospitalized after delivery |
| Newborn length of stay | Up to 4 weeks after birth | Days hospitalized after birth |
Countries
United States
Outcome results
None listed