PregnancyNCT03831126
Stress and Fetal Brain Development
An observational study of Pregnancy, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Betamethason Sodium Phosphate
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- German speakers (fluently)
- Gestational age between 28 and 34 weeks
- Treatment with Betamethasone for improvement of fetal lung function -
Who cannot join
- Smoking (regularly)
- Alcohol and drug consumption during pregnancy
- Congenital fetal disorders
- Women with bed rest
- acute depression or other psychiatric disorder (self report)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076
Miriam Linneweh, Dr, +4970712982211, miriam.linneweh@med.uni-tuebingen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Betamethason Sodium Phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethason Sodium PhosphateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| betamethasone treatment | Not described Receives: Drug: Betamethason Sodium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal and maternal heart rate
Measurement by fMEG
Measured: 8 weeks
Secondary outcomes (1)
fetal and neonatal brain activity in response to auditory and visual stimuli
Measurement by fMEG
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831126
- Sponsor's protocol ID
- PerFet_maternal_stress_fMEG
- Status last verified
- May 2024
- First submitted
- 30 Jan 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Stress on Fetal Brain Development
- ClinicalTrials.gov ID
- NCT03831126
- Acronym / sponsor ID
- PerFet_maternal_stress_fMEG
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| betamethasone treatment | – | Drug: Betamethason Sodium Phosphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (3 listed)
- German speakers (fluently)
- Gestational age between 28 and 34 weeks
- Treatment with Betamethasone for improvement of fetal lung function -
Key exclusion criteria (5 listed)
- Smoking (regularly)
- Alcohol and drug consumption during pregnancy
- Congenital fetal disorders
- Women with bed rest
- acute depression or other psychiatric disorder (self report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethason Sodium PhosphateFirst 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 | Drug | betamethasone treatment |
Primary outcome
fetal and maternal heart rate
Time frame: 8 weeks
Measurement by fMEG
1 secondary outcome
fetal and neonatal brain activity in response to auditory and visual stimuli
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Pauluschke-Fröhlich, MD (07071 2983111, jan.pauluschke-froehlich@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal and maternal heart rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.