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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02786420
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : May 4, 2021
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sherin Devaskar, University of California, Los Angeles

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.

Condition or disease
Placental Disease

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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Innovations for Placental Assessment in Response to Environmental Pollution
Actual Study Start Date : October 2, 2015
Actual Primary Completion Date : June 3, 2020
Actual Study Completion Date : October 3, 2020

Resource links provided by the National Library of Medicine

Pregnant women

Primary Outcome Measures :
  1. 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)

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Currently pregnant women who meet following eligibility criteria below

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786420

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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Sherin Devaskar, MD University of California, Los Angeles
Pedersen M, Giorgis-Allemand L, Bernard C, Aguilera I, Andersen AM, Ballester F, Beelen RM, Chatzi L, Cirach M, Danileviciute A, Dedele A, Eijsden Mv, Estarlich M, Fernández-Somoano A, Fernández MF, Forastiere F, Gehring U, Grazuleviciene R, Gruzieva O, Heude B, Hoek G, de Hoogh K, van den Hooven EH, Håberg SE, Jaddoe VW, Klümper C, Korek M, Krämer U, Lerchundi A, Lepeule J, Nafstad P, Nystad W, Patelarou E, Porta D, Postma D, Raaschou-Nielsen O, Rudnai P, Sunyer J, Stephanou E, Sørensen M, Thiering E, Tuffnell D, Varró MJ, Vrijkotte TG, Wijga A, Wilhelm M, Wright J, Nieuwenhuijsen MJ, Pershagen G, Brunekreef B, Kogevinas M, Slama R. Ambient air pollution and low birthweight: a European cohort study (ESCAPE). Lancet Respir Med. 2013 Nov;1(9):695-704. doi: 10.1016/S2213-2600(13)70192-9. Epub 2013 Oct 15.

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Responsible Party: Sherin Devaskar, Distinguished Professor of Pediatrics, Mattel Executive Endowed Chair, Department of Pediatrics, Executive Director, UCLA Children's Discovery and Innovation Institute, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02786420    
Other Study ID Numbers: 15-001388
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sherin Devaskar, University of California, Los Angeles:
magnetic resonance imaging
environmental air pollutants
Additional relevant MeSH terms:
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Placenta Diseases
Pregnancy Complications