TocophobiaNCT05627336
Tokophobia ; Our Clinical Experience
An observational study of Tocophobia and Pregnancy Complications, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Fear of childbirth, or what has historically been called tokophobia, is often described as a severe fear of birth and pathological fear of childbirth. The reasons for fear of childbirth are stated as biological reasons, psychological reasons and lack of social support. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tocophobia, Pregnancy Complications
- What is being tested?
- pregnant women in the 3rd trimester
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Study population: 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic. Pregnant women between the ages of 18 and 40
Who may be able to join
- 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic.
- Pregnant women between the ages of 18 and 40
Who cannot join
- Those in the risky pregnancy category (preeclampsia, gdm, iugr… etc.)
- Known to have fetal anomaly during follow-ups
- Those with chronic disease
- Those with sexually transmitted diseases
- Those with a history of cesarean section
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
Istanbul
About this study
Official title: Causes and Frequency of Tokophobia, Its Effect on Cesarean Delivery Rates: Our Clinical Experience
Fear of childbirth, or what has historically been called tokophobia, is often described as a severe fear of birth and pathological fear of childbirth. The reasons for fear of childbirth are stated as biological reasons, psychological reasons and lack of social support. However, it is still not possible to clearly explain the reasons for the fear of childbirth in pregnant women and the risk factors affecting them. The reasons for the fear of childbirth and the affecting factors have not been fully explained.
Read the detailed description
The aim of this study is to examine the relationship between fear of childbirth and anxiety sensitivity in pregnant women, and whether the mode of delivery changes depending on this fear and these data. The aim of the authors is to reveal the frequency and causes of tokophobia in pregnant women followed in their clinics and to show the birth patterns of these patients.
- Conditions
- Tocophobia, Pregnancy Complications
- Being tested
- pregnant women in the 3rd trimester
- Keywords
- vaginal birth, cesarean delivery, fear of childbirth
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnant women in the 3rd trimesterDiagnostic test
Pregnant women who are in their third trimester and will give birth in the clinic will form the study group. These pregnant women will be measured by applying a set of questionnaires to measure their fear of childbirth.
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of tokophobia
patients will be administered W-DEQ: Wijma Delivery Expectancy/Experience Questionnaire part A. As a result, those who score above 85 will be diagnosed with tokophobia.
this test; Each question has a point equivalent, and the diagnosis will be reached by adding all the points at the end.
Measured: 2 months
type of birth
The birth types of patients diagnosed with tokophobia will be examined. It will be tried to show statistically whether tokophobia increases cesarean section rates or not.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TocophobiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627336
- Sponsor's protocol ID
- ATADEK/ 11.2022
- Status last verified
- Jul 2024
- First submitted
- 16 Nov 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Frequency of Tokophobia, Its Effect on Cesarean Delivery Rates: Our Clinical Experience
- ClinicalTrials.gov ID
- NCT05627336
- Acronym / sponsor ID
- ATADEK/ 11.2022
- Conditions
- Tocophobia, Pregnancy Complications
- Keywords
- vaginal birth, cesarean delivery, fear of childbirth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 25 Nov 2022 (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.
Fear of childbirth, or what has historically been called tokophobia, is often described as a severe fear of birth and pathological fear of childbirth. The reasons for fear of childbirth are stated as biological reasons, psychological reasons and lack of social support. However, it is still not possible to clearly explain the reasons for the fear of childbirth in pregnant women and the risk factors affecting them. The reasons for the fear of childbirth and the affecting factors have not been fully explained.
Detailed description
The aim of this study is to examine the relationship between fear of childbirth and anxiety sensitivity in pregnant women, and whether the mode of delivery changes depending on this fear and these data. The aim of the authors is to reveal the frequency and causes of tokophobia in pregnant women followed in their clinics and to show the birth patterns of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic. Pregnant women between the ages of 18 and 40
Key inclusion criteria (2 listed)
- 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic.
- Pregnant women between the ages of 18 and 40
Key exclusion criteria (5 listed)
- Those in the risky pregnancy category (preeclampsia, gdm, iugr… etc.)
- Known to have fetal anomaly during follow-ups
- Those with chronic disease
- Those with sexually transmitted diseases
- Those with a history of cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregnant women in the 3rd trimesterPregnant women who are in their third trimester and will give birth in the clinic will form the study group. These pregnant women will be measured by applying a set of questionnaires to measure their fear of childbirth. | Diagnostic test | – |
Primary outcome
diagnosis of tokophobia
Time frame: 2 months
patients will be administered W-DEQ: Wijma Delivery Expectancy/Experience Questionnaire part A. As a result, those who score above 85 will be diagnosed with tokophobia. this test; Each question has a point equivalent, and the diagnosis will be reached by adding all the points at the end.
type of birth
Time frame: 2 months
The birth types of patients diagnosed with tokophobia will be examined. It will be tried to show statistically whether tokophobia increases cesarean section rates or not.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tocophobia and Pregnancy Complications, run by Kanuni Sultan Suleyman 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 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of tokophobia (time frame: 2 months). The study lists 2 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 18 Jul 2024.