NCT07228806

Brief Summary

These events are largely due to pelvic floor dysfunction that develops after pregnancy. Kegel exercises and core stabilisation exercises performed in the postpartum period are important in preventing pelvic floor dysfunction. However, considering the mother's adaptation process to both the baby and her new life in the postpartum period, there may be problems with exercise compliance. Increasing exercise compliance through telerehabilitation can be effective in preventing pelvic floor dysfunction and improving women's quality of life.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Nov 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2026

Last Updated

February 24, 2026

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 13, 2025

Last Update Submit

February 22, 2026

Conditions

Postpartum Pelvic Floor Function and Symptoms

Keywords

Postpartum WomanPelvic Floor DysfunctionTelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Pelvic floor muscle strength assessment

    Pelvic floor muscle strength assessment using the SineBravo 2-channel EMG Biofeedback device

    Before exercises programme and 8th week of exercises programme

Secondary Outcomes (3)

  • Measurement of the distance between the inferior edge of the pubic symphysis and the anteromedial edge of the puborectalis muscle using transperineal ultrasound

    Before exercises programme and 8th week of exercises programme

  • Pelvic floor questionnaire for pregnant and postpartum women

    Before exercises programme and 8th week of exercises programme

  • Female Sexual Function Index

    Before exercises programme and 8th week of exercises programme

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL
Other: Pelvic floor exercises with telerehabilitation

Conventional group

ACTIVE COMPARATOR
Other: Pelvic floor exercises without telerehabilitation

Interventions

Pelvic floor exercises with telerehabilitationOTHER

Patients in the telerehabilitation group will be assigned the same 8-week exercise programme as those in the conventional group to be carried out at home. Unlike the conventional group, patients in the telerehabilitation group will be contacted by telephone each week throughout the exercise programme to check their adherence to the programme, to ask if they have encountered any problems with the exercise programme, and to answer any questions they may have.

Telerehabilitation group
Pelvic floor exercises without telerehabilitationOTHER

An 8-week exercise programme consisting of 45-minute Kegel exercises and core stabilisation exercises per day will be provided for implementation at home in the conventional group.

Conventional group

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 and 45
  • Primiparous women
  • Term vaginal delivery
  • weeks postpartum
  • Willingness to participate in the study

You may not qualify if:

  • Presence of faecal or urinary incontinence prior to pregnancy
  • Use of assisted delivery devices (vacuum, forceps)
  • Presence of neurological disease
  • Presence of psychiatric illness or cognitive problems that make it difficult to answer questions
  • Caesarean section delivery
  • History of diabetes mellitus
  • Perineal rupture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Ayşe Naz Kalem Özgen, 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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PM&R Specialist

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

May 9, 2026

Study Completion (Estimated)

May 9, 2026

Last Updated

February 24, 2026

Record last verified: 2025-11

Locations

TU(1)