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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02791568
Eligibility Criteria:
Subject Population (Pilot study)
Inclusion Criteria:
1. Women with singleton, low-risk pregnancies
2. Gravida 1 (first pregnancy); or Gravida 2 (second pregnancy with first pregnancy carried to term or miscarried prior to 14 weeks or terminated); or Gravida 3 (third pregnancy with first and second pregnancies carried to term or one previous pregnancy carried to term and the other previous pregnancy miscarried prior to 14 weeks or terminated)
3. Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
4. Non-obese (BMI 18.5-29.9 kg/M2) or Obese (Class I BMI 30-34.9 kg/M2 or Class II BMI 35-39.9 kg/M2) based on pregravid BMI
Exclusion Criteria:
1. Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
2. Tobacco or alcohol or drug use in current pregnancy
3. Pre-existing autoimmune conditions or other maternal chronic diseases like renal diseases, chronic hypertension, thrombophilia, type I or II diabetes or any vasculopathy
4. History of sickle cell anemia or sickle cell trait
5. High risk for gestational hypertension, pre-eclampsia, HELLP syndrome, fetal growth restriction (FGR), abruptio placentae secondary to hypertension or pre-eclampsia, stillbirth/intrauterine fetal death
Subject Population (Main study) Inclusion Criteria
Control Group:
1. Non-obese (pregravid BMI 18.5-29.9 Kg/M2)25 (N=80)
2. Women with singleton, low-risk pregnancies
3. Gravida 1 (first pregnancy); or Gravida 2 (second pregnancy with first pregnancy carried to term or miscarried prior to 14 weeks or terminated); or Gravida 3 (third pregnancy with first and second pregnancies carried to term or one previous pregnancy carried to term and the other previous pregnancy miscarried prior to 14 weeks or terminated)
4. Ultrasound-confirmed pregnancy dating prior to 14 weeks gestation
5. Gestational age at screening prior to 16 weeks
Study Group:
1. Obese (pregravid Class I BMI 30-34.9 kg/M2 or pregravid Class II BMI 35-39.9 kg/M2) (N=80)
2. Women with singleton, low-risk pregnancies
3. Gravida 1 (first pregnancy); or Gravida 2 (second pregnancy with first pregnancy carried to term or miscarried prior to 14 weeks or terminated); or Gravida 3 (third pregnancy with first and second pregnancies carried to term or one previous pregnancy carried to term and the other previous pregnancy miscarried prior to 14 weeks or terminated)
4. Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
5. Gestational age at screening prior to 16 weeks
Exclusion Criteria
Control and Study Groups:
1. Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
2. Tobacco/alcohol/drug use in current pregnancy
3. Pre-existing autoimmune conditions or other maternal chronic diseases like renal diseases, chronic hypertension, thrombophilia, type I or II diabetes or any vasculopathy
4. History of sickle cell anemia or sickle cell trait
5. High risk for gestational hypertension, pre-eclampsia, HELLP syndrome, fetal growth restriction (FGR), abruptio placentae secondary to hypertension or pre-eclampsia, stillbirth/intrauterine fetal death
a. The determination of whether or not the subjects are considered high risk for the conditions described above will be based on medical and obstetrical history review by clinical investigators with expertise in Maternal Fetal Medicine.
6. Contraindications to MRI (such as claustrophobia, metallic implant, etc.) based on MRI Screening
7. Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
8. Any physical or psychological symptom, based on the clinical judgment of the study physician that would make a participant unsuitable for the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02791568
Study Brief:
Protocol Section:
NCT02791568