Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00724594
Eligibility Criteria:
Inclusion Criteria:
Participants had all of the following to qualify:
* Chorioamnionitis, defined as either 1) clinical diagnosis of choriomanionitis 2) maternal fever greater than or equal to 100 degrees F in the presence of rupture of membranes or 2 of the following: uterine tenderness, maternal WBC \> 15,000 cells/mm, fetal tachycardia \> 160 bpm, malodorous amniotic fluid, or in preterm group only, rupture of membranes and active preterm labor.
* Gestational age ≥ 24 completed weeks, by first trimester ultrasound or date of last menstrual period.
* No greater than 4 hours from onset of fever or diagnosis.
Exclusion Criteria:
Participants had none of the following:
* Asthma, steroid-dependent
* Clinical sepsis, whether viral or bacterial in nature, defined as fever with signs of cardiovascular compromise in mother (blood pressure \< 90/50, heart rate \> 120 bpm, need for oxygen due to maternal saturations below 92%, pneumonia, pyelonephritis, or meningitis)
* Seizure disorder
* Fetal weight or biparietal diameter less than the 10th% for gestational age
* Suspected major genetic or congenital abnormality
* Fetal distress which demands immediate delivery (poor fetal biophysical profile, late decelerations, sinusoidal fetal heart rate pattern)
* Participation in another therapeutic clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00724594
Study Brief:
Protocol Section:
NCT00724594