Brief Summary

The purpose of this study is to test the application of newly generated placental MRI protocols in human subjects. This new method avoids the need for contrast agent administration and thus provides improved safety for MRI use during pregnancy.

Our objectives are:

1. Establish the normal variance of placental perfusion in pregnant women across gestation.

2. Apply our new MRI protocol in women at high risk for vascular compromise (i.e., smokers and those with a prior history of placental insufficiency) to test the sensitivity and specificity of this new technique for predicting adverse clinical outcomes.

   We hypothesize that, by using non-contrast MRI, we will detect decreased placental perfusion domain function in pregnancies complicated by placental insufficiency.

   Endpoint: Successful development of these tools will significantly advance non-invasive imaging of placental function by creating a method that quantitatively determines placental perfusion while preserving the vascular characteristics that are unique to the human placenta.

Inclusion Criteria

Chart review to identify potential study participants in early pregnancy to allow the first scan to be scheduled and completed in the 12 – 16 week gestational age range.

Pregnant women will be recruited based on inclusion criteria for 3 subject groups:

            1) non-smokers with low risk for placental insufficiency (N=60)

            2) Smokers (N=90)

            3) Non-smokers who are at a high risk for adverse outcomes based on prior clinical history (N=150)

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-HCG and certain menstrual history, or early ultrasound, identified prior to12 weeks of gestation

3. Intent to deliver at University of Utah

Inclusion criteria for low risk group:

1. At least one successful pregnancy defined as a non-anomalous, singleton delivery at 37-41 weeks gestation with no evidence of hypertensive disease.

2. No history of a second or third trimester loss

3. No history of fetal growth restriction

4. No medical problems requiring chronic treatment

5. No history of preterm birth

Inclusion criteria for high risk group:

1. Multiparous

2. History of pregnancy complicated by placental insufficiency in the immediate preceding pregnancy

   1. Severe preeclampsia requiring preterm delivery
   2. Preterm delivery due to placental insufficiency (e.g. FGR, oligohydramnios, abnormal umbilical artery Doppler’s, abnormal antenatal testing)
   3. FGR delivered at term with an additional finding concerning for placental cause (e.g. Oligo, abnormal UA Doppler)
   4. Stillbirth attributed to placental cause, regardless of gestational age

       

3. Not currently a smoker

4. If preterm birth, there should be no PROM or evidence of infection by pathology report

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 including twin demise regardless of placentation

3. Major fetal anomalies known to be associated with abnormal growth (i.e. major congenital heart defect, gastroschisis)

4. Current use of vasoactive medication (aspirin(low dose aspirin 81 – 100 mg, are eligible), heparin, anti-hypertensives).

5. Current maternal history of alcohol or illicit drug use

6. Current medical problems requiring chronic on going treatment:

   • Cancer

   • Endocrine disease (including not controlled thyroid disease, adrenal disease)

   • Pregestational diabetes (including gestational diabetes* in previous pregnancies) *Individuals with thyroid diseases  controlled by medication must have a  TSH <2.5 prior to 1^st MRI to be eligible). With hypothyroid, controlled by medication.  Must have a TSH <2.5 confirmed within the last 6 months. 

   • Renal disease with altered renal function (creatinine > 0.9 mg or proteinuria)

   • Epilepsy or other seizure disorder

   • Any collagen disease (lupus erythematosus, scleroderma, etc)

   • Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)

   • Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia

   • Chronic pulmonary disease requiring regular use of medication (exercise asthma or seasonal allergies are allow)

   • Heart disease

   • Prior or current thromboembolism.

   • Antiphospholipid Syndrome.

7. Prior history of claustrophobia

8. Metal implants. Inclusion of participants with a metal implant will be determined after discussion with each site’s MRI team and will be reviewed on a case-by-case basis, based on type of implant and where the implant is located in the body.

9. Increased aneuploidy risk based on ultrasound findings or genetic testing

10. Intent to deliver outside University of Utah Hospital