Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03168178
Study type Interventional
Source University of Utah
Contact
Status Withdrawn
Phase Phase 4
Start date June 8, 2017
Completion date July 26, 2018

See also
  Status Clinical Trial Phase
Terminated NCT05603624 - Effect of Sterile Versus Clean Gloves Intrapartum and Postpartum Infections at Term N/A
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Withdrawn NCT02886910 - Chorioamnionitis: Observation of at Risk Infants vs Standard Care N/A
Completed NCT01633294 - Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term Phase 2/Phase 3
Recruiting NCT00299637 - Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis Phase 0
Completed NCT00153517 - Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy Phase 2
Completed NCT00397735 - N-acetylcysteine in Intra-amniotic Infection/Inflammation Phase 1/Phase 2
Completed NCT00814905 - Treatment of Chorioamnionitis After Delivery N/A
Completed NCT01852188 - Intrapartum Study of Sterile and Clean Gloves N/A
Completed NCT00879190 - Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis Phase 2/Phase 3
Recruiting NCT04307069 - Management of Prelabor Rupture of the Membranes at Term N/A
Completed NCT03576560 - Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
Completed NCT00185991 - Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis N/A
Completed NCT00070746 - Perinatal Infections in Pakistan N/A
Completed NCT03636698 - Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
Not yet recruiting NCT01778725 - Early Identification of Brain Insult in Chorioamnionitis N/A
Recruiting NCT01988168 - Closure of Skin in ChorioAmnionitis Research Pilot Study N/A
Completed NCT04651309 - Assessment of Labour Progress by Intrapartum Ultrasound N/A
Completed NCT00724594 - Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio) Phase 1/Phase 2