- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07774936
Fetal Health Locus of Control, Maternal Anxiety, and Cardiotocography in High-Risk Pregnancies
The Relationship Between Fetal Health Locus of Control Perceptions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnant Women
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Fetal health locus of control reflects pregnant women's beliefs regarding the factors that determine the health of their unborn child. These beliefs may influence health-related behaviors during pregnancy. Maternal anxiety may also affect fetal heart rate regulation through autonomic and neuroendocrine mechanisms.
This study will prospectively evaluate high-risk pregnant women at 32 weeks of gestation or later who are undergoing routine non-stress testing at the Perinatology Outpatient Clinic. After written informed consent is obtained, participants will complete the Fetal Health Locus of Control Scale and the Beck Anxiety Inventory on the same day as their routine 20-minute NST.
The Fetal Health Locus of Control Scale consists of three dimensions: Internal Health Locus of Control, Chance Health Locus of Control, and Powerful Others Health Locus of Control. NST recordings will be evaluated according to FIGO-based criteria by an experienced investigator. Baseline fetal heart rate, accelerations, reactivity, decelerations, and other relevant cardiotocographic parameters will be recorded.
This study aims prospective cross-sectional evaluation of high-risk pregnant women undergoing routine non-stress testing. The primary objective is to investigate the relationships among fetal health locus of control perceptions, maternal anxiety levels, and fetal cardiotocography parameters. Secondary analyses will examine the relationships of these variables with maternal sociodemographic and obstetric characteristics.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Doruk C Katlan
- Número de teléfono: +905353475411
- Correo electrónico: dcek2000@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: Nebahat Uzunay
- Número de teléfono: +905052609436
- Correo electrónico: nebahatuzunay@gmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Reclutamiento
- Istanbul Training and Research Hospital
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Contacto:
- Doruk C Katlan
- Número de teléfono: +905353475411
- Correo electrónico: dcek2000@yahoo.com
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Sub-Investigador:
- Nebahat Uzunay
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Sub-Investigador:
- Filiz Değirmenci
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Contacto:
- Nebahat Uzunay
- Número de teléfono: +905052609436
- Correo electrónico: nebahatuzunay@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Singleton pregnancy at 32 weeks of gestation or later
- Being followed for a high-risk pregnancy
- No known diagnosed psychiatric disorder and no current psychiatric medication use
- Absence of a fetal condition considered likely to affect the NST tracing
- Maternal age between 18 and 45 years
Exclusion Criteria:
- Gestational age below 32 weeks and/or multiple pregnancy
- Presence of a fetal condition considered likely to affect the NST tracing
- Acute maternal infection or an obstetric emergency
- Known diagnosed psychiatric disorder and/or current psychiatric medication use
- Maternal age below 18 years or above 45 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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High-Risk Pregnant Women
Pregnant women at 32 weeks of gestation or later who are being followed for a high-risk pregnancy and undergo routine non-stress testing.
Participants will complete the Fetal Health Locus of Control Scale and the Beck Anxiety Inventory on the same day as their routine NST.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Association Between Fetal Health Locus of Control and Maternal Anxiety
Periodo de tiempo: At the single study visit, on the same day as the routine NST
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The relationship between scores obtained from the Fetal Health Locus of Control Scale and maternal anxiety measured using the Beck Anxiety Inventory will be evaluated.
The Internal Health Locus of Control, Chance Health Locus of Control, and Powerful Others Health Locus of Control dimensions will be analyzed separately.
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At the single study visit, on the same day as the routine NST
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Association Between Fetal Health Locus of Control and Cardiotocography Parameters
Periodo de tiempo: During the 20-minute routine NST performed at the single study visit
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Associations between fetal health locus of control dimensions and NST parameters, including baseline fetal heart rate, number of accelerations, reactivity, and presence of decelerations, will be evaluated.
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During the 20-minute routine NST performed at the single study visit
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Association Between Maternal Anxiety and Cardiotocography Parameters
Periodo de tiempo: During the 20-minute routine NST performed at the single study visit
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The relationship between maternal anxiety measured using the Beck Anxiety Inventory and NST parameters, including baseline fetal heart rate, number of accelerations, reactivity, and presence of decelerations, will be evaluated.
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During the 20-minute routine NST performed at the single study visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Associations With Sociodemographic and Obstetric Characteristics
Periodo de tiempo: At the single study visit
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Associations of fetal health locus of control, maternal anxiety levels, and cardiotocography parameters with maternal sociodemographic and obstetric characteristics, including age, gravidity, education level, income level, consanguinity, smoking status, and pre-pregnancy preparation, will be evaluated.
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At the single study visit
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ISTANBUL TRH - 14.04.2026-121
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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