Placenta Imaging Project



Status:Recruiting
Healthy:No
Age Range:18 - 52
Updated:7/25/2018
Start Date:October 13, 2016
End Date:August 2020
Contact:Women's Health Research Unit Confidential Recruitment Line
Email:PIP@ohsu.edu
Phone:503-494-8748

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Functional Imaging of Human Placenta by MRI

The purpose of this study is to test the application of newly generated magnetic resonance
imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The
primary objective is to validate and establish the utility of placental MRI in pregnant
women. The study will be entirely MRI-technology based with collection of placental tissue at
the time of infant delivery for later correlative studies.

The placenta provides all the nutrition from a pregnant mother to a developing fetus. A
placenta that functions normally is needed to ensure normal fetal growth and development.
Unfortunately, the placenta is the least understood human organ even though it is involved in
all pregnancy complications. The placenta is so poorly understood because our current methods
to look at it during pregnancy, like ultrasound, do not provide enough information about
placental growth and function.

This study will help provide information about:

- How the placenta grows and develops during pregnancy

- How the placenta delivers nutrients, like oxygen to the developing fetus

- If placental function using new advanced imaging tools can predict pregnancy
complications like fetal growth restriction, stillbirth, preeclampsia and preterm labor

This study will explore how blood flow to the placenta affects placental growth, fetal
growth, and oxygen delivery to the fetus. Blood flow to the placenta may determine how the
placenta supports fetal growth and development. Having a way to measure placental function
during pregnancy may provide a way to understand normal pregnancies but importantly also
identify pregnancies at increased risk for pregnancy complications.

Additionally we want to have an ancillary intrauterine growth restriction (IUGR) arm; the
objective of this ancillary study is to test the sensitivity of the placental MRI protocol in
women with confirmed cases of IUGR in the third trimester.

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
We found this trial at
2
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-8748
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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