High-risk PregnancyNCT07774949
Association of Maternal Thyroid Function and Anxiety With Fetal Cardiotocography Parameters in High-Risk Pregnancies
An observational study of High-risk Pregnancy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the association between maternal thyroid function, maternal anxiety levels, and fetal cardiotocography parameters in high-risk pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- High-risk Pregnancy
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will consist of women with high-risk singleton pregnancies at 32 weeks of gestation or later who are followed at the Perinatology Outpatient Clinic of Istanbul Training and Research Hospital and who undergo routine thyroid function testing and non-stress testing.
Who may be able to join
- Singleton pregnancy at 32 weeks of gestation or later
- Pregnancy being followed as a high-risk pregnancy
- Age between 18 and 45 years
- Availability of routine thyroid function test results and non-stress test assessment
- Ability and willingness to provide written informed consent
Who cannot join
- Gestational age below 32 weeks
- Multiple pregnancy
- Fetal conditions that may affect interpretation of the non-stress test tracing
- Acute maternal infection
- Presence of an acute obstetric condition
- Previously diagnosed psychiatric disorder
- Current use of psychiatric medication
- Age younger than 18 years or older than 45 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Training and Research Hospital
Istanbul
Doruk C Katlan, +905353475411, dcek2000@yahoo.com
Nebahat Uzunay
About this study
Official title: Association Between Maternal Thyroid Functions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnancies
This prospective observational study aims to investigate the association between maternal thyroid function, maternal anxiety levels, and fetal cardiotocography parameters in high-risk pregnancies. Pregnant women at 32 weeks of gestation or later who are followed in the perinatology outpatient clinic for high-risk pregnancy will be included.
Maternal thyroid function test results, including thyroid-stimulating hormone (TSH) and free thyroxine (fT4), obtained as part of routine clinical care will be recorded. Maternal anxiety will be assessed using the Beck Anxiety Inventory. Fetal well-being will be evaluated using a routine 20-minute non-stress test (NST), including baseline fetal heart rate, accelerations, reactivity, and the presence of decelerations.
The associations between maternal anxiety scores, thyroid hormone levels and thyroid status, and fetal cardiotocography parameters will be analyzed. Sociodemographic and obstetric characteristics will also be evaluated in relation to these parameters.
- Conditions
- High-risk Pregnancy
- Keywords
- High-risk pregnancy, Maternal anxiety, Thyroid dysfunction, Cardiotocography, Beck Anxiety Inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk Pregnant Women | Pregnant women with singleton high-risk pregnancies at 32 weeks of gestation or later who undergo routine thyroid function testing and non-stress testing as part of their clinical follow-up. Maternal anxiety will be assessed using the Beck Anxiety Inventory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Maternal Anxiety Level and NST Parameters
The association between Beck Anxiety Inventory scores and fetal non-stress test parameters will be evaluated.
Measured: At study enrollment, during the same-day assessment
Association Between Maternal Thyroid Function and NST Parameters
The association between maternal TSH and free T4 levels and fetal non-stress test parameters will be evaluated.
Measured: At study enrollment, using third-trimester thyroid function test results and same-day NST assessment
Secondary outcomes (1)
Association of Sociodemographic and Obstetric Characteristics With Maternal Anxiety, Thyroid Function, and NST Parameters
Measured: At study enrollment, using third-trimester thyroid function test results and same-day NST and anxiety assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start27 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doruk Cevdi Katlan, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774949
- Sponsor's protocol ID
- ISTANBUL TRH - 27.03.2026-100
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Maternal Thyroid Functions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnancies
- ClinicalTrials.gov ID
- NCT07774949
- Acronym / sponsor ID
- ISTANBUL TRH - 27.03.2026-100
- Conditions
- High-risk Pregnancy
- Keywords
- High-risk pregnancy, Maternal anxiety, Thyroid dysfunction, Cardiotocography, Beck Anxiety Inventory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 2026 (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.
This prospective observational study aims to investigate the association between maternal thyroid function, maternal anxiety levels, and fetal cardiotocography parameters in high-risk pregnancies. Pregnant women at 32 weeks of gestation or later who are followed in the perinatology outpatient clinic for high-risk pregnancy will be included.
Maternal thyroid function test results, including thyroid-stimulating hormone (TSH) and free thyroxine (fT4), obtained as part of routine clinical care will be recorded. Maternal anxiety will be assessed using the Beck Anxiety Inventory. Fetal well-being will be evaluated using a routine 20-minute non-stress test (NST), including baseline fetal heart rate, accelerations, reactivity, and the presence of decelerations.
The associations between maternal anxiety scores, thyroid hormone levels and thyroid status, and fetal cardiotocography parameters will be analyzed. Sociodemographic and obstetric characteristics will also be evaluated in relation to these parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Pregnant Women | – | –Pregnant women with singleton high-risk pregnancies at 32 weeks of gestation or later who undergo routine thyroid function testing and non-stress testing as part of their clinical follow-up. Maternal anxiety will be assessed using the Beck Anxiety Inventory. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of women with high-risk singleton pregnancies at 32 weeks of gestation or later who are followed at the Perinatology Outpatient Clinic of Istanbul Training and Research Hospital and who undergo routine thyroid function testing and non-stress testing.
Key inclusion criteria (5 listed)
- Singleton pregnancy at 32 weeks of gestation or later
- Pregnancy being followed as a high-risk pregnancy
- Age between 18 and 45 years
- Availability of routine thyroid function test results and non-stress test assessment
- Ability and willingness to provide written informed consent
Key exclusion criteria (8 listed)
- Gestational age below 32 weeks
- Multiple pregnancy
- Fetal conditions that may affect interpretation of the non-stress test tracing
- Acute maternal infection
- Presence of an acute obstetric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Maternal Anxiety Level and NST Parameters
Time frame: At study enrollment, during the same-day assessment
The association between Beck Anxiety Inventory scores and fetal non-stress test parameters will be evaluated.
Association Between Maternal Thyroid Function and NST Parameters
Time frame: At study enrollment, using third-trimester thyroid function test results and same-day NST assessment
The association between maternal TSH and free T4 levels and fetal non-stress test parameters will be evaluated.
1 secondary outcome
Association of Sociodemographic and Obstetric Characteristics With Maternal Anxiety, Thyroid Function, and NST Parameters
Time frame: At study enrollment, using third-trimester thyroid function test results and same-day NST and anxiety assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 High-risk Pregnancy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doruk C Katlan (+905353475411, dcek2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Maternal Anxiety Level and NST Parameters (time frame: At study enrollment, during the same-day assessment). The study lists 2 primary outcomes in all. 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 19 Aug 2026.