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Fetal Biomarkers of Chronic Maternal Stress During Pregnancy (FELICITy)

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ClinicalTrials.gov Identifier: NCT03389178
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
PD Dr. S. M. Lobmaier, Technische Universität München

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.

Condition or disease Intervention/treatment
Prenatal Stress Diagnostic Test: Cohen Perceived Stress Scale-10 (PSS-10)

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Fetal Early Non-invasive Biomarkers of Chronic Maternal Stress During Pregnancy Resulting in Alterations of Infant Cognitive Development
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
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)
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)

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)
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



Primary Outcome Measures :
  1. fetal hear rate (FHR) signatures [ Time Frame: 12 months ]
    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.

  2. methylation levels by Epigenome-Wide Association Study (EWAS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. neuro development at 18 months of age [ Time Frame: 18 months after birth ]
    Infants' cognitive development will be assessed by Bayley Scale III of Infant development (BSID) at 18 months of age. The BSID is composed by a series of tests aimed at evaluating cognitive, motor and behavioral development on infants from age 0-3 years. The Mental Development Index and the Psychomotor Development Index components have a mean score of 100 and a standard deviation of 15 (range of 55 to 145). Scores between 70-84 indicate mildly delayed performance, and scores ≤ 69 indicate significantly delayed performance. Approximately 13.5 % of tested infants are expected to fall in those categories. Maternal psychological distress during pregnancy was associated in a dose-response manner with BSID scores in 2 years-old children. A specialized Psychologist, who will be blind regarding maternal stress categorization, will administer the tests.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT03389178


Contacts
Contact: Silvia Lobmaier, MD 00498941405417 silvia.lobmaier@tum.de
Contact: Marta Antonelli, PhD martantonelli@gmail.com

Locations
Germany
Klinikum rechts der Isar Recruiting
München, Bavaria, Germany, 81675
Contact: Silvia Lobmaier, MD, PhD    0049894140 ext 5417    silvia.lobmaier@tum.de   
Contact: Marta Antonelli, PhD       martantonelli@gmail.com   
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Silvia Lobmaier, MD, PhD Frauenklinik, Klinikum rechts der Isar, Technical University of Munich

Responsible Party: PD Dr. S. M. Lobmaier, Principal Investigator,, Technische Universität München
ClinicalTrials.gov Identifier: NCT03389178     History of Changes
Other Study ID Numbers: FELICITy
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PD Dr. S. M. Lobmaier, Technische Universität München:
prenatal stress
fetal autonomic nervous system
multidimensional FHR variability assessment