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Stress and Fetal Brain Development

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ClinicalTrials.gov Identifier: NCT03831126
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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Brief Summary:
The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

Condition or disease Intervention/treatment
Pregnancy Drug: Betamethason Sodium Phosphate

Detailed Description:
Over the last decades there is growing evidence that increased maternal stress levels lead to an adverse effect on the physiological, metabolic and neuronal development of the fetus during gestation with possible long-lasting effects. Several studies showed that maternal stress also affects fetal endocrine processes during pregnancy and increases the risk for childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute stress related to the action of the artificial glucocorticoid betamethasone on fetal heart and brain activity. The fetal activity will be measured with biomagnetic sensors.
Study Design
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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Impact of Stress on Fetal Brain Development
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
betamethasone treatment Drug: Betamethason Sodium Phosphate
First measurement: 12-36 hours after betamethasone treatment Second measurement: within five days after betamethasone treatment and two weeks Third measurement (neonatal measurement): 1-8 weeks after birh


Outcome Measures
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Primary Outcome Measures :
  1. fetal and maternal heart rate [ Time Frame: 8 weeks ]
    Measurement by fMEG


Secondary Outcome Measures :
  1. fetal and neonatal brain activity in response to auditory and visual stimuli [ Time Frame: 8 weeks ]
    Measurement by fMEG


Other Outcome Measures:
  1. blood sugar levels [ Time Frame: 8 weeks ]
    Measurement by fMEG


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:   Probability Sample
Study Population
Pregnant women
Criteria

Inclusion Criteria:

  • German speakers (fluently)
  • Gestational age between 28 and 34 weeks
  • Treatment with Betamethasone for improvement of fetal lung function -

Exclusion Criteria:

  • Smoking (regularly)
  • Alcohol and drug consumption during pregnancy
  • Congenital fetal disorders
  • Women with bed rest
  • acute depression or other psychiatric disorder (self report)
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): NCT03831126


Contacts
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Contact: Jan Pauluschke-Fröhlich, MD 07071 2983111 jan.pauluschke-froehlich@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen, Department of Women's Health Recruiting
Tuebingen, Germany, 72076
Contact: Miriam Linneweh, Dr    +4970712982211    miriam.linneweh@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03831126    
Other Study ID Numbers: PerFet_maternal_stress_fMEG
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Anti-Asthmatic Agents
Respiratory System Agents