Fetal Biomarkers of Chronic Maternal Stress During Pregnancy

NCT03389178 | Unknown

• 1 other identifier: FELICITy
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prenatal stress; fetal autonomic nervous system; multidimensional FHR variability assessment

Outcome Measures

Primary Outcomes (2)

• fetal hear rate (FHR) signatures

  The impact of prenatal stress (PS) on autonomic nervous system (ANS) activity will be analyzed by deploying advanced methods of FHR monitoring: phase-rectified signal averaging (PRSA), multidimensional FHR variability analysis and assessment of maternal-fetal heart rate synchronization. We expect that children affected by PS show early alterations of fetal ANS.

  12 months

• methylation levels by Epigenome-Wide Association Study (EWAS)

  12 months

Secondary Outcomes (1)

• neuro development at 18 months of age

  18 months after birth

Study Arms (2)

stress group (SG)

We will identify prospective subjects according with the inclusion criteria of the study, consistent on singleton pregnant women between 18 to 45 years of age in their third trimester (at least 28 weeks gestation). Upon acceptance participants will enter to Phase I-IV. Women and participants will be categorized as stressed or controls after scoring the Cohen Perceived Stress Scale-10 (PSS-10). The PSS-10 has been validated in German speaking populations and will be a quick tool for screening stress among prospective subjects. For the purposes of the current study, a participant with a PSS-10 score ≥19 will be categorized as stressed and entered into Phase II. Recruitment will continue until reaching the aimed cohort of n=75 subjects/group.

Diagnostic Test: Cohen Perceived Stress Scale-10 (PSS-10)

control group (CG)

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. Recruitment will continue until reaching the aimed cohort of n=75 subjects/group.

Diagnostic Test: Cohen Perceived Stress Scale-10 (PSS-10)

Interventions

Cohen Perceived Stress Scale-10 (PSS-10) DIAGNOSTIC_TEST

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

control group (CG); stress group (SG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A cohort of the population of women attending the center of perinatology at the Department of Obstetrics and Gynecology at the Klinikum rechts der Isar of the Technische Universität München (TUM) for having birth will fall in the group of persons with higher perceived stress levels that might concomitantly carry fetuses that show altered sympathetic and vagal activity.

You may qualify if:

• singleton pregnant women between 18 to 45 years of age in their third trimester (at least 28 weeks gestation)

You may not qualify if:

• serious placental alterations;
• fetal malformations;
• maternal severe illness during pregnancy (i.e. preclampsia),
• maternal drug or alcohol abuse,
• preterm birth (less than 37 weeks) and
• Cord blood pH\<7,10.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Related Publications (2)

• Sharma R, Frasch MG, Zelgert C, Zimmermann P, Fabre B, Wilson R, Waldenberger M, MacDonald JW, Bammler TK, Lobmaier SM, Antonelli MC. Maternal-fetal stress and DNA methylation signatures in neonatal saliva: an epigenome-wide association study. Clin Epigenetics. 2022 Jul 14;14(1):87. doi: 10.1186/s13148-022-01310-x.

  PMID: 35836289 DERIVED

• Lobmaier SM, Muller A, Zelgert C, Shen C, Su PC, Schmidt G, Haller B, Berg G, Fabre B, Weyrich J, Wu HT, Frasch MG, Antonelli MC. Fetal heart rate variability responsiveness to maternal stress, non-invasively detected from maternal transabdominal ECG. Arch Gynecol Obstet. 2020 Feb;301(2):405-414. doi: 10.1007/s00404-019-05390-8. Epub 2019 Nov 28.

  PMID: 31781889 DERIVED

Study Officials

• Silvia Lobmaier, MD, PhD

  Frauenklinik, Klinikum rechts der Isar, Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Lobmaier, MD

CONTACT

00498941405417; silvia.lobmaier@tum.de

Marta Antonelli, PhD

CONTACT

martantonelli@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 3, 2018
• Study Start: July 1, 2016
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

DE (1)