- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07774949
Association of Maternal Thyroid Function and Anxiety With Fetal Cardiotocography Parameters in High-Risk Pregnancies
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Doruk C Katlan
- Telefonnummer: +905353475411
- E-mail: dcek2000@yahoo.com
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Rekruttering
- Istanbul Training and Research Hospital
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Kontakt:
- Doruk C Katlan
- Telefonnummer: +905353475411
- E-mail: dcek2000@yahoo.com
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Underforsker:
- Nebahat Uzunay
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Underforsker:
- Filiz Değirmenci
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Association Between Maternal Anxiety Level and NST Parameters
Tidsramme: At study enrollment, during the same-day assessment
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The association between Beck Anxiety Inventory scores and fetal non-stress test parameters will be evaluated.
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At study enrollment, during the same-day assessment
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Association Between Maternal Thyroid Function and NST Parameters
Tidsramme: At study enrollment, using third-trimester thyroid function test results and same-day NST assessment
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The association between maternal TSH and free T4 levels and fetal non-stress test parameters will be evaluated.
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At study enrollment, using third-trimester thyroid function test results and same-day NST assessment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Association of Sociodemographic and Obstetric Characteristics With Maternal Anxiety, Thyroid Function, and NST Parameters
Tidsramme: At study enrollment, using third-trimester thyroid function test results and same-day NST and anxiety assessment
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At study enrollment, using third-trimester thyroid function test results and same-day NST and anxiety assessment
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ISTANBUL TRH - 27.03.2026-100
Plan for individuelle deltagerdata (IPD)
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