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NCT03831126 Clinical Trial

Stress and Fetal Brain Development

Pregnancy Clinical Trial

Official title:
The Impact of Stress on Fetal Brain Development

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03831126
Other study ID # PerFet_maternal_stress_fMEG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source University Hospital Tuebingen
Contact Jan Pauluschke-Fröhlich, MD
Phone 07071 2983111
Email jan.pauluschke-froehlich@med.uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University Hospital Tuebingen, Department of Women's Health Tuebingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other blood sugar levels Measurement by fMEG 8 weeks
Primary fetal and maternal heart rate Measurement by fMEG 8 weeks
Secondary fetal and neonatal brain activity in response to auditory and visual stimuli Measurement by fMEG 8 weeks
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