Placenta Imaging Project

NCT ID: NCT02749851

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 379 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-13
• Study Completion Date: 2020-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

High Risk Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-smokers

Pregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention.

MRI

Intervention Type: DEVICE

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy in 3 groups of human subjects: 1) non-smokers, 2) smokers, 3) individuals at high risk for adverse outcome. The objective of this work is to develop a new non-invasive clinical tool for early identification of placental dysfunction.

Smokers

Pregnant women that identify as smokers will receive the MRI Imaging intervention.

MRI

Intervention Type: DEVICE

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy in 3 groups of human subjects: 1) non-smokers, 2) smokers, 3) individuals at high risk for adverse outcome. The objective of this work is to develop a new non-invasive clinical tool for early identification of placental dysfunction.

High risk/Non-Smokers

Pregnant women that identify as non-smokers who are at a high risk for adverse outcomes based on prior clinical history will receive the MRI Imaging intervention.

MRI

Intervention Type: DEVICE

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy in 3 groups of human subjects: 1) non-smokers, 2) smokers, 3) individuals at high risk for adverse outcome. The objective of this work is to develop a new non-invasive clinical tool for early identification of placental dysfunction.

Confirmed IUGR

Pregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy

MRI - IUGR

Intervention Type: DEVICE

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy. The objective of this ancillary arm is to further test the sensitivity of placental magnetic resonance imaging to detect abnormal perfusion and oxygenation in confirmed cases of IUGR between gestational ages 28 to 36 weeks.

Interventions

MRI

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy in 3 groups of human subjects: 1) non-smokers, 2) smokers, 3) individuals at high risk for adverse outcome. The objective of this work is to develop a new non-invasive clinical tool for early identification of placental dysfunction.

Intervention Type: DEVICE

MRI - IUGR

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy. The objective of this ancillary arm is to further test the sensitivity of placental magnetic resonance imaging to detect abnormal perfusion and oxygenation in confirmed cases of IUGR between gestational ages 28 to 36 weeks.

Intervention Type: DEVICE

Other Intervention Names

magnetic resonance imaging; magnetic resonance imaging

Eligibility Criteria

Inclusion Criteria

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.

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

1. No history of a second or third trimester loss

2. No history of fetal growth restriction

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Antonio E. Frias

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Frias, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Schabel MC, Roberts VHJ, Gibbins KJ, Rincon M, Gaffney JE, Streblow AD, Wright AM, Lo JO, Park B, Kroenke CD, Szczotka K, Blue NR, Page JM, Harvey K, Varner MW, Silver RM, Frias AE. Quantitative longitudinal T2* mapping for assessing placental function and association with adverse pregnancy outcomes across gestation. PLoS One. 2022 Jul 19;17(7):e0270360. doi: 10.1371/journal.pone.0270360. eCollection 2022.

Reference Type: DERIVED

PMID: 35853003 (View on PubMed)

Other Identifiers

U01HD087182

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU IRB 15196

Identifier Type: -

Identifier Source: org_study_id