Intrapartum Fever: Antibiotics Versus no Treatment
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|ClinicalTrials.gov Identifier: NCT03168178|
Recruitment Status : Withdrawn (Participant enrollment was much more challenging than anticipated.)
First Posted : May 30, 2017
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chorioamnionitis Intrapartum Fever Intra-amniotic Infection||Drug: Standard Antibiotic Treatment Other: No Antibiotic Treatment||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Low risk women will be randomized to standard antibiotic treatment versus no antiobiotics.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)|
|Actual Study Start Date :||June 8, 2017|
|Actual Primary Completion Date :||July 26, 2018|
|Actual Study Completion Date :||July 26, 2018|
Active Comparator: Standard Antibiotic Treatment
Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Drug: Standard 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
Experimental: No Antibiotic Treatment
No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Other: No Antibiotic Treatment
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. [ 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.
- Positive blood culture [ Time Frame: 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 [ Time Frame: Up to 4 weeks after birth ]Admission of the infant to the Newborn Intensive Care Unit
- Newborn length of stay [ Time Frame: Up to 4 weeks after birth ]Days hospitalized after birth
- Maternal endometritis [ Time Frame: 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 [ Time Frame: Up to 4 weeks after birth ]Days hospitalized after delivery
- Patient satisfaction [ Time Frame: 6-8 weeks after delivery ]Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery
- Cost [ Time Frame: Up to 4 weeks after birth ]The hospital charges for mother and infant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168178
|United States, Utah|
|University of Utah, Department of Obstetrics & Gynecology|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Heather Campbell, MD||University of Utah|