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Clinical Trials/NCT03831126
NCT03831126RecruitingNot Applicable

The Impact of Stress on Fetal Brain Development

University Hospital Tuebingen1 site in 1 country24 target enrollmentStarted: February 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
1
Primary Endpoint
fetal and maternal heart rate

Study Overview

Brief Summary

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

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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

betamethasone treatment

Intervention: Betamethason Sodium Phosphate (Drug)

Outcomes

Primary Outcomes

fetal and maternal heart rate

Time Frame: 8 weeks

Measurement by fMEG

Secondary Outcomes

  • fetal and neonatal brain activity in response to auditory and visual stimuli(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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