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NCT Number: NCT07774949

Association of Maternal Thyroid Function and Anxiety With 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.

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Key information

Conditions

High-Risk Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Doruk C Katlan

CONTACT

[email protected]

+905353475411

Filiz Değirmenci

SUB_INVESTIGATOR

Nebahat Uzunay

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Doruk C Katlan

CONTACT

[email protected]

+905353475411

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Association Between Maternal Thyroid Functions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnancies

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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