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:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT03218735
Eligibility Criteria:
Inclusion Criteria:
* Singleton pregnancy
* Plan for vaginal delivery. Patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section.
* Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
* Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
* No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
* LGA defined as estimated fetal weight (EFW) \> 90th percentile by Hadlock formula but \<4500 grams
Exclusion Criteria:
* Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)
* Planned cesarean delivery
* Polyhydramnios
* Known major fetal anomalies
* Multiple gestation or selective reduction of multiple gestation after 14 weeks
* Previous stillbirth at term
* Indications for delivery at \<39 weeks. Common examples include:
* Placenta previa
* Placenta accreta
* Vasa previa
* History of classical cesarean section or myomectomy
* Human immunodeficiency virus (HIV)
* Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket \<2.0cm)
* High-risk pregnancy as determined by the physician. Common examples include:
* Pre-gestational diabetes or gestational diabetes on medication
* Chronic hypertension on medication
* Maternal cardiac disease
* Asthma requiring oral steroids during pregnancy
* Chronic renal disease
* Antiphospholipid syndrome
* Hyperthyroidism
* Prior stillbirth
* Systemic lupus erythematous
* Hemoglobinopathies such as sickle cell disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT03218735
Study Brief:
Protocol Section:
NCT03218735