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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT02749851
Eligibility Criteria:
Pregnant women will be recruited based on inclusion criteria for 3 subject groups:
1. Non-smokers with low risk for placental insufficiency
2. Smokers
3. Non-smokers who are at a high risk for adverse outcomes based on prior clinical history.
Inclusion criteria: Pregnant women fulfilling inclusion criteria, and not meeting exclusion criteria, will be invited to participate in this study.
Inclusion criteria for all groups:
1. Maternal age over 18 years and able to give informed consent
2. Pregnant patient, as defined by positive pregnancy test for elevated β-human chorionic gonadotropin (HCG) and certain menstrual history, or early ultrasound, identified prior to 14 weeks of gestation
Inclusion criteria for low risk group:
1. No history of a second or third trimester loss
2. No history of fetal growth restriction
Inclusion criteria for high risk group:
1. History of pregnancy complicated by placental insufficiency in a previous singleton pregnancy (i.e. severe preeclampsia requiring preterm delivery, preterm delivery due to placenta insufficiency (eg. fetal growth restriction (FGR), oligohydramnios, abnormal umbilical artery Doppler's, abnormal antenatal testing), FGR \<10% delivered at term; stillbirth attributed to placental cause, regardless of gestational age
2. Not currently a smoker
3. Pregnancy at risk for placental insufficiency due to clinical concerns (eg. chronic hypertension)
4. Spontaneous preterm birth \<34 weeks
Exclusion criteria: These criteria will exclude women whose medications, personality traits or obstetric conditions could confound their ability to complete a 1 hour MRI scan.
1. Individuals with intellectual disability or who are incarcerated
2. Multiple gestation
3. Major fetal anomalies known to be associated with abnormal growth (i.e. major congenital heart defect, gastroschisis)
4. Current maternal history of alcohol or illicit drug use
5. Current medical problems requiring chronic treatment:
* Cancer
* Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
* Chronic pulmonary disease including asthma requiring regular use of medication
6. Prior history of claustrophobia
7. Metal implants
8. Increased aneuploidy risk based on ultrasound findings or genetic testing
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
52 Years
Study:
NCT02749851
Study Brief:
Protocol Section:
NCT02749851