NCT07488455

Brief Summary

The aim of this study is to evaluate the effect of written or visual information provided outside of routine postpartum follow-up on pelvic floor knowledge and pelvic floor function in women during the postpartum period.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

June 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 18, 2026

Last Update Submit

June 16, 2026

Conditions

Postpartum Pelvic Floor Function and Symptoms

Keywords

postpartumknowledgepelvic floor dysfunctioneducationvideo-basedwritten

Outcome Measures

Primary Outcomes (1)

  • Pelvic Floor Health Knowledge Questionnaire

    second day of postpartum and 6th week of postpartum

Secondary Outcomes (2)

  • Pelvic Floor Questionnaire for Pregnant Women and Postpartum Women

    second day of postpartum and 6th week of postpartum

  • Pelvic Floor Distress Index-20

    second day of postpartum and 6th week of postpartum

Study Arms (3)

video-based education group

EXPERIMENTAL

Women in the first group will be shown an educational video covering pelvic floor anatomy, pelvic floor dysfunction, risk factors, and pelvic floor exercises via a QR code prior to their postpartum discharge.

Behavioral: video-based education

written education group

ACTIVE COMPARATOR

The women in the second group will be given a written text with the same content as that provided to the women in the first group, and this text will also be explained to them verbally.

Behavioral: written education

Conventional group

NO INTERVENTION

Women in the third group will undergo routine postnatal follow-up.

Interventions

video-based educationBEHAVIORAL

An educational video covering pelvic floor anatomy, pelvic floor dysfunction, risk factors, and pelvic floor exercises

video-based education group
written educationBEHAVIORAL

A written text covering pelvic floor anatomy, pelvic floor dysfunction, risk factors, and pelvic floor exercises

written education group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostpartum female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18 and 45
  • Single pregnancy
  • Full-term delivery
  • Be willing to participate in the study
  • Be literate in Turkish

You may not qualify if:

  • Presence of fecal or urinary incontinence prior to pregnancy
  • Presence of neurological or orthopedic problems that could cause pelvic floor dysfunction
  • Presence of psychiatric illness or cognitive impairment that makes it difficult to answer questions
  • History of pelvic surgery
  • History of high-risk pregnancy (preeclampsia, eclampsia, multiple pregnancy, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Ayşe Naz Kalem Ozgen, specialist

CONTACT

+90 0312 797 00 00kalemnaz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PM&R Specialist

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 23, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

June 17, 2026

Record last verified: 2026-03

Locations

TU(1)