NCT05627336

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

November 16, 2022

Last Update Submit

July 17, 2024

Conditions

Keywords

vaginal birthcesarean deliveryfear of childbirth

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 months

Interventions

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • rd 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pinar KADIROGULLARI Assoc.Prof

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations