- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Doruk C Katlan
- Phone Number: +905353475411
- Email: dcek2000@yahoo.com
Study Contact Backup
- Name: Nebahat Uzunay
- Phone Number: +905052609436
- Email: nebahatuzunay@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul Training and Research Hospital
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Contact:
- Doruk C Katlan
- Phone Number: +905353475411
- Email: dcek2000@yahoo.com
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Sub-Investigator:
- Nebahat Uzunay
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Sub-Investigator:
- Filiz Değirmenci
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Contact:
- Nebahat Uzunay
- Phone Number: +905052609436
- Email: nebahatuzunay@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association Between Fetal Health Locus of Control and Maternal Anxiety
Time Frame: 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
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Associations With Sociodemographic and Obstetric Characteristics
Time Frame: 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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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ISTANBUL TRH - 14.04.2026-121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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