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

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ClinicalTrials.gov Identifier: NCT02786420
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sherin Devaskar, University of California, Los Angeles

Study Description
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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 Design
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Study Type : Observational
Estimated Enrollment : 320 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

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Groups and Cohorts
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Group/Cohort
Observational
Pregnant women


Outcome Measures
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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.

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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


Contacts
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Contact: Sherin Devaskar, MD 310-825-5095 SDevaskar@mednet.ucla.edu
Contact: Carla Janzen, MD 310-794-7274 CJanzen@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Sherin Devaskar, MD    310-825-5095    SDevaskar@mednet.ucla.edu   
Contact: Carla Janzen, MD    310-794-7274    cjanzen@mednet.ucla.edu   
Principal Investigator: Sherin Devaskar, MD         
Principal Investigator: Carla Janzen, MD         
Principal Investigator: Kyung Hyun Sung, Ph.D.         
Principal Investigator: Beate Ritz, MD         
Sponsors and Collaborators
University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Sherin Devaskar, MD University of California, Los Angeles
More Information
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Publications:
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     History of Changes
Other Study ID Numbers: 15-001388
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
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:
pregnancy
magnetic resonance imaging
environmental air pollutants
Additional relevant MeSH terms:
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Placenta Diseases
Pregnancy Complications