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Fetal Biomarkers of Chronic Maternal Stress During Pregnancy

NCT03389178 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2018-01-03

No results posted yet for this study

Summary

The investigators´ main hypothesis is that prenatal stress (PS)- induced programming during fetal and postnatal development is reflected in epigenetic and autonomic nervous system (ANS) biomarkers which can be harnessed for early detection and follow-up of affected children. By integrating multiple non-invasively obtainable sources of information using novel epigenetic, electrophysiologic and statistical approaches, the trial could yield progress in maternal-fetal medicine, offering a more precise and truly personalized prediction and new possibilities for designing interventions to improve neurodevelopmental outcomes of pregnancy affected by PS.

Conditions

  • Prenatal Stress

Interventions

DIAGNOSTIC_TEST

Cohen Perceived Stress Scale-10 (PSS-10)

Participants with a PSS-10 score ≥19 will be categorized as stressed and entered into Phase II. For every consented subject categorized as stressed, the next screened participant matching for maternal and gestational age with a PSS-10 score \< 19 will be entered into Phase II as control

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Silvia Lobmaier, MD, PhD · Frauenklinik, Klinikum rechts der Isar, Technical University of Munich

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2020-04-30
Completion
2020-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389178 on ClinicalTrials.gov