Stress and Fetal Brain Development

NCT ID: NCT03831126

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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betamethasone treatment

Betamethason Sodium Phosphate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Tuebingen, Department of Women's Health

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jan Pauluschke-Fröhlich, MD

Role: CONTACT

07071 2983111

Facility Contacts

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Miriam Linneweh, Dr

Role: primary

+4970712982211

Other Identifiers

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PerFet_maternal_stress_fMEG

Identifier Type: -

Identifier Source: org_study_id

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