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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Recruitment Status : Withdrawn (Participant enrollment was much more challenging than anticipated.)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
Sponsor:
Information provided by (Responsible Party):
Heather Campbell, University of Utah

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.

Condition or disease Intervention/treatment Phase
Chorioamnionitis Intrapartum Fever Intra-amniotic Infection Drug: Standard Antibiotic Treatment Other: No Antibiotic Treatment Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Low risk women will be randomized to standard antibiotic treatment versus no antiobiotics.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Need for NICU admission [ Time Frame: Up to 4 weeks after birth ]
    Admission of the infant to the Newborn Intensive Care Unit

  3. Newborn length of stay [ Time Frame: Up to 4 weeks after birth ]
    Days hospitalized after birth

  4. 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.

  5. Maternal length of stay [ Time Frame: Up to 4 weeks after birth ]
    Days hospitalized after delivery

  6. 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

  7. Cost [ Time Frame: Up to 4 weeks after birth ]
    The hospital charges for mother and infant



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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United States, Utah
University of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Heather Campbell, MD University of Utah

Publications:

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Responsible Party: Heather Campbell, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03168178     History of Changes
Other Study ID Numbers: 91955
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chorioamnionitis
Fever
Body Temperature Changes
Signs and Symptoms
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents