High-risk PregnancyNCT07774936
Fetal Health Locus of Control, Maternal Anxiety, and Cardiotocography 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 cross-sectional study aims to evaluate the relationships among fetal health locus of control (FHLC) perceptions, maternal anxiety levels, and fetal cardiotocography parameters in high-risk pregnant women. 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
- 14 Apr 2026to Dec 2028
- How long will I take part?
- 1 Day
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
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, +905052609436, nebahatuzunay@gmail.com
About this study
Official title: The Relationship Between Fetal Health Locus of Control Perceptions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnant Women
This prospective observational cross-sectional study aims to evaluate the relationships among fetal health locus of control (FHLC) perceptions, maternal anxiety levels, and fetal cardiotocography parameters in high-risk pregnant women. Pregnant women at 32 weeks of gestation or later who undergo routine non-stress testing (NST) at the Perinatology Outpatient Clinic will be invited to participate. On the same day as the routine NST, participants will complete the Fetal Health Locus of Control Scale and the Beck Anxiety Inventory. Associations between FHLC dimensions, maternal anxiety levels, and NST parameters, including baseline fetal heart rate, number of accelerations, reactivity, and presence of decelerations, will be evaluated.
Read the 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.
- Conditions
- High-risk Pregnancy
- Keywords
- Fetal Health Locus of Control, Maternal Anxiety, High-Risk Pregnancy, Cardiotocography
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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Fetal Health Locus of Control and Maternal Anxiety
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.
Measured: At the single study visit, on the same day as the routine NST
Association Between Fetal Health Locus of Control and Cardiotocography Parameters
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.
Measured: During the 20-minute routine NST performed at the single study visit
Association Between Maternal Anxiety and Cardiotocography Parameters
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.
Measured: During the 20-minute routine NST performed at the single study visit
Secondary outcomes (1)
Associations With Sociodemographic and Obstetric Characteristics
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.
Measured: At the single study visit
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 start14 Apr 2026
- Primary completionMay 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
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
- NCT07774936
- Sponsor's protocol ID
- ISTANBUL TRH - 14.04.2026-121
- 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
- The Relationship Between Fetal Health Locus of Control Perceptions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT07774936
- Acronym / sponsor ID
- ISTANBUL TRH - 14.04.2026-121
- Conditions
- High-risk Pregnancy
- Keywords
- Fetal Health Locus of Control, Maternal Anxiety, High-Risk Pregnancy, Cardiotocography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- May 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 cross-sectional study aims to evaluate the relationships among fetal health locus of control (FHLC) perceptions, maternal anxiety levels, and fetal cardiotocography parameters in high-risk pregnant women. Pregnant women at 32 weeks of gestation or later who undergo routine non-stress testing (NST) at the Perinatology Outpatient Clinic will be invited to participate. On the same day as the routine NST, participants will complete the Fetal Health Locus of Control Scale and the Beck Anxiety Inventory. Associations between FHLC dimensions, maternal anxiety levels, and NST parameters, including baseline fetal heart rate, number of accelerations, reactivity, and presence of decelerations, will be evaluated.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 Fetal Health Locus of Control and Maternal Anxiety
Time frame: At the single study visit, on the same day as the routine NST
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.
Association Between Fetal Health Locus of Control and Cardiotocography Parameters
Time frame: During the 20-minute routine NST performed at the single study visit
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.
Association Between Maternal Anxiety and Cardiotocography Parameters
Time frame: During the 20-minute routine NST performed at the single study visit
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.
1 secondary outcome
Associations With Sociodemographic and Obstetric Characteristics
Time frame: At the single study visit
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 5 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 Fetal Health Locus of Control and Maternal Anxiety (time frame: At the single study visit, on the same day as the routine NST). The study lists 3 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.