Eligibility Details:
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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
