NCT03168178

Intrapartum Fever: Antibiotics Versus no Treatment

A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chorioamnionitis
• Intrapartum Fever
• Intra-amniotic Infection

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2017-06-08
• Primary completion: 2018-07-26
• Completion: 2018-07-26
• First posted: 2017-05-30
• Last updated: 2018-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study