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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT04251702
Eligibility Criteria:
Inclusion Criteria:
* Maternal age: 18-41 years at the due date
* Term gestation: 37-41 weeks estimated gestational age (EGA)
* Single fetus in a vertex presentation: Pregnancy with only one fetus that is in a head down position with the occiput leading into the pelvis upon admission to the hospital.
Exclusion Criteria:
* Pre-existing or gestational diabetes requiring medical management: The diagnosis of diabetes of any kind requiring management with medications including but not limited to insulin, glyburide, and metformin as indicated in the health record.
* Pre-existing or gestational hypertension or pre-eclampsia requiring medical management: The diagnosis of hypertension of any kind requiring management with medications including but not limited to long-term hypertension management such as methyldopa and short-term or emergency hypertension management such as labetalol or magnesium sulfate as indicated in the health record.
* Suspected fetal anomaly or intrauterine growth restriction: Any diagnosed fetal anomalies or intrauterine growth restriction as indicated in the health record.
* Use of amnioinfusion prior to sample collection: Amnioinfusion, the infusion of fluids into the uterus using an intrauterine catheter may affect AFL concentrations. Any amnioinfusion prior to sample collection will exclude participants from continued participation.
* Fetal distress prior to or during sample collection: Category 3 fetal heart tracing as defined by the National Institute of Child Health and Development22, absent fetal heart rate variability with recurrent late deceleration, recurrent variable decelerations, bradycardia, or sinusoidal rhythm.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
41 Years
Study:
NCT04251702
Study Brief:
Protocol Section:
NCT04251702