Intrapartum Fever: Antibiotics Versus no Treatment
| Status: | Withdrawn |
|---|---|
| Conditions: | Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/25/2018 |
| Start Date: | June 8, 2017 |
| End Date: | July 26, 2018 |
A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)
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.
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.
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.
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.
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)
We found this trial at
1
site
30 North 1900 East
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
Phone: 801-581-8425
Click here to add this to my saved trials
