Imaging Innovations for Placental Assessment in Response to Environmental Pollution (PARENTs) (PARENTs)

April 30, 2021 updated by: Sherin Devaskar, University of California, Los Angeles

Imaging Innovations for Placental Assessment in Response to Environmental Pollution

How environmental pollution contributes to poor pregnancy outcome is poorly understood. The first trimester of pregnancy is a particularly vulnerable time period for the developing fetus and a mother's exposure to air pollution may alter the way that the placenta is established and how it functions throughout the rest of pregnancy. This project aims to expand and develop new MRI technologies to assess real-time placental structure and function as pregnancy develops from the first to the third trimester so that early detection, prevention strategies, and early treatment of placental dysfunction as a result of pollution exposures may be developed.

Study Overview

Status

Completed

Conditions

Detailed Description

Many epidemiological studies have associated exposure to traffic-derived air pollution from motor vehicles, air toxins from industry and other environmental toxins by pregnant women with measures of poor birth outcomes including preeclampsia (PE), preterm birth (PTB) and intra-uterine growth restriction (IUGR). Preeclampsia, preterm labor and IUGR, collectively known as ischemic placental disease, are strongly correlated with infant morbidity and a host of adult diseases ranging from coronary artery disease to cancer. Although it is widely believed that the pathophysiological mechanisms leading to complications of ischemic placental disease and placental insufficiency have similar biological origins, starting as early as defective placental implantation, to date there are no predictive studies that prospectively examine placental structure and/or function. This may be related to existing technologies, routinely employed in clinical decision-making, such as ultrasonography and certain biomarkers, lacking precision in the first trimester, and adequate sensitivity and specificity in the second to third trimesters. Thus, assessment and prediction of normalcy versus aberrancy of placental function are lacking. Therefore, the overarching objective of this proposal is to develop and evaluate a suit of cutting-edge multi-parametric magnetic resonance imaging (mp-MRI) technologies (primary predictor), and translate these novel placental imaging modalities to assessing the impact of environmental pollution exposure on prediction of the composite of placental aberrancy/insufficiency and related outcomes (PE, PTB and IUGR) (primary outcome).

Our central hypothesis is that chronic exposure to high rates of environmental pollution, independent of socio-economic status (SES), increases the risk of placental insufficiency due to early gestational development of adverse placental structure/function as detected by mp-MRI technological advances.

To test this hypothesis, our interdisciplinary research team at UCLA will first develop non-contrast freebreathing placental mp-MRI, consisting of multi-delay pseudo-continuous arterial spin labeling (pCASL) perfusion and high-resolution multi-contrast structural MRI, which will provide reproducible measures of placental perfusion and tissue microstructure (AIM 1). The novel mp-MRI techniques will be compared to the uterine artery Doppler ultrasound through pregnancy and validated ultimately by the gold standard histological pathology and vascularity of the post-parturient placenta (AIM 2). Lastly, the investigators will perform in-depth analyses of recruited subjects for exposure to environmental pollution and correlate their rates of exposure to extensively collected pregnancy outcomes, towards building a predictive model (AIM 3). Our specific aims are:

AIM 1: Develop non-contrast free-breathing placental mp-MRI techniques that can non-invasively characterize the in vivo placental perfusion and microstructure through all trimesters.

A. Develop a free-breathing multi-delay pCASL sequence using background-suppressed localized-volume 3D GRASE imaging for quantitative measurement of placental perfusion within a 5-10 min scan (1.5x1.5x2 mm3 resolution).

B. Develop a free-breathing high-resolution golden-angle 3D stack-of-radial sequence with self-navigation and retrospective motion compensation using compressed sensing for mapping placental microstructure within a 5-10 min scan (1x1x1 mm3 isotropic resolution).

AIM 2: Evaluate placental mp-MRI by longitudinal comparison with uterine artery Doppler ultrasound through gestation as a predictive marker of placental insufficiency.

A. Conduct a 3-year prospective cohort study of pregnant women, performing newly developed mp-MRI (AIM1) in the 1st and 2nd trimesters in parallel to ultrasound measurement of uterine artery Doppler, to assess mp-MRI prediction capability versus ultrasound.

B. Collect detailed pregnancy outcome data of prospective cohort, including diagnosis, neonatal outcome, and placenta for pathological and histological analysis to ascertain risk factors for placental insufficiency as a response to environmental exposures (AIM 3).

AIM 3: Perform in-depth analyses in recruited subjects to determine associations of environmental pollution exposures and both placental mp-MRI measurements and concomitant pregnancy outcomes.

A. Perform in-depth analyses to measures of modeled environmental pollution exposure in our recruited subjects to assess associations with mp-MRI measures of placental structure and perfusion throughout gestation, taking into account multiple confounding factors such as maternal age at delivery, race/ethnicity, and SES.

B. Correlate mp-MRI measures of placental structure and perfusion throughout gestation with pregnancy outcomes, post-parturient assessment of placental weight, pathology, and neonatal outcomes. These studies will establish the impact of environmental pollution on placental structure and function, and related pregnancy outcomes, with obstetric and neonatal practices embracing surveillance tactics based on the residential location of pregnant women and their offspring. In addition, the proposed research will establish the potential for early recognition of placental insufficiency, thereby staging future strategies of preventive and interventional therapies targeting reversal before encountering detrimental consequences.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Currently pregnant women who meet following eligibility criteria below

Description

Inclusion Criteria:

  • 18 years of age or older
  • Planning to delivery at a UCLA hospital
  • Carrying a viable pregnancy
  • Not carrying multiple gestation

Exclusion Criteria:

  • Known fetal chromosomal or structural abnormalities
  • Contraindications to having MRI evaluation
  • Inability to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Observational
Pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic Placental Disease and Environment
Time Frame: 11 Weeks Gestational Age - Delivery
To use multi-parametric MRI technology to assess the impact of environment pollution exposure on prediction of placental insufficiency and related outcomes (pre-eclampsia, preterm birth, and IUGR)
11 Weeks Gestational Age - Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

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

Investigators

  • Principal Investigator: Sherin Devaskar, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2015

Primary Completion (Actual)

June 3, 2020

Study Completion (Actual)

October 3, 2020

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-001388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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