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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT00454012
Eligibility Criteria:
Inclusion Criteria:
* Spontaneous or induced labor
* Gestational ages between 35 - 42 weeks
* Singleton pregnancy
* Intrapartum non-reassuring or uninterpretable FHR tracing defined as any tracing that the Labor and Delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. Inclusive FHR patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (\<120/min) that resolves, persistent fetal tachycardia (\>160/min for \>60 min,) or any other FHR patterns necessitating further fetal well being evaluation (like scalp pH or scalp stimulation).
Exclusion Criteria:
* Multiple gestation
* Gestational age \< 35 weeks
* Patient denial to undergo ultrasound examination during labor
* Abnormal FHR tracing requiring stat delivery
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
45 Years
Study:
NCT00454012
Study Brief:
Protocol Section:
NCT00454012