NCT06487923

Brief Summary

The aim of this study is to investigate the relationship between knowledge and awareness of pelvic floor health and dyspareunia, pelvic floor dysfunctions, and quality of life in postpartum women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
Last Updated

July 9, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 28, 2024

Last Update Submit

July 5, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pelvic Floor Health Knowledge Quiz

    This scale is a self-report tool developed to measure pelvic floor knowledge and awareness.The scale was developed by Wala'a Al-Deges in 2019. The original version is in Turkish. It consists of 29 questions divided into 3 sub-parameters. A high score indicates a high level of awareness.

    Baseline

  • Carol Postpartum Sexual Function And Dyspareunia Assessment Scale

    This scale is a self-report tool developed to evaluate sexual functions and dyspareunia who have resumed vaginal intercourse after vaginal delivery. It developed by Pérez-García, Solís-Muñoz. Turkish Validity and reliability study was conducted by Evili. The scale consists of 11 items and 4 subparameters in a Likert-type format. Except for 'preparation for sexual activity', a high score indicates a high level of dysfunction.

    Baseline

  • Sociodemographic Information Form

    The demographic information form consisted of 27 questions to determine and classify individuals' socio-demographic characteristics, including descriptive features such as age, height, weight, BMI, marital status, recorded using this form.

    Baseline

Secondary Outcomes (3)

  • Nottingham Health Profile

    Baseline

  • Prolapse and Incontinence Knowledge Questionnaire

    Baseline

  • Global Pelvic Floor Symptom Bother Questionnaire

    Baseline

Study Arms (1)

Postpartum Women

298 primiparous women who have given birth vaginally in the last year

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primiparous women who have given birth within the past year aged 18 and older

You may qualify if:

  • Being a native speaker of Turkish
  • Being in the first year of postpartum
  • Women who had a vaginal delivery
  • Primiparous women
  • Women aged 18 and over

You may not qualify if:

  • Women who have not given birth
  • Multiparous women
  • Women who had a cesarean delivery
  • Having difficulty to understanding evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
20 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 5, 2024

Study Start

April 1, 2024

Primary Completion

May 15, 2024

Study Completion

June 28, 2024

Last Updated

July 9, 2024

Record last verified: 2024-06

Locations