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

NCT02786420 | Completed

• 1 other identifier: 15-001388
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Placental Disease

Keywords

pregnancy; magnetic resonance imaging; environmental air pollutants

Outcome Measures

Primary Outcomes (1)

• Ischemic Placental Disease and Environment

  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

Study Arms (1)

Observational

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Currently pregnant women who meet following eligibility criteria below

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (75)

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• Lee B, Janzen C, Aliabadi AR, Lei MYY, Wu H, Liu D, Vangala SS, Devaskar SU, Sung K. Early pregnancy imaging predicts ischemic placental disease. Placenta. 2023 Sep 7;140:90-99. doi: 10.1016/j.placenta.2023.07.297. Epub 2023 Jul 31.

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Biospecimen

Retention: SAMPLES WITH DNA

Frozen samples of blood and urine will be kept for further study related to this project involving markers relevant to placental insufficiency that may be discovered in the future. A gross assessment of the placenta will be performed by weighing the disc with cord and membranes removed. Cord insertion, length, diameter, coiling, number of vessels, focal lesions, membrane color, thickness, translucency, attachment, disc dimensions, range of thickness, fetal surface vascular distribution, pigmentation and site of rupture will be recorded. Microscopic assessment of H\&E stained sections will be performed to detect any inflammatory/infectious processes, villous development/maturity, decidual vasculopathy, infarct/fibrin deposition, or other processes that may be associated with placental insufficiency and fetal development.

MeSH Terms

Conditions

Placenta Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sherin Devaskar, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Pediatrics, Mattel Executive Endowed Chair, Department of Pediatrics, Executive Director, UCLA Children's Discovery and Innovation Institute

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: June 1, 2016
• Study Start: October 2, 2015
• Primary Completion: June 3, 2020
• Study Completion: October 3, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)