Stress and Fetal Brain Development

May 14, 2024 updated by: University Hospital Tuebingen

The Impact of Stress on Fetal Brain Development

The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal and maternal heart rate
Time Frame: 8 weeks
Measurement by fMEG
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal and neonatal brain activity in response to auditory and visual stimuli
Time Frame: 8 weeks
Measurement by fMEG
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood sugar levels
Time Frame: 8 weeks
Measurement by fMEG
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PerFet_maternal_stress_fMEG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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