NCT05051176

Brief Summary

This study will evaluate the prevalence of diastasis m. rectus abdominis after delivery. Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

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 8, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

September 10, 2021

Last Update Submit

July 4, 2022

Conditions

Diastasis of m. Rectus Abdominis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Diastasis Recti Abdominis in Postpartum Women.

    IRD distance measured by a linear probe 2D usg, 4.5 cm above the navel, 4.5 cm below the navel. At rest, and when raising the lower limbs.

    Six weeks to up to 6 months after birth

Secondary Outcomes (2)

  • Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.

    Six weeks to up to 6 months after birth.

  • Relationship between Diastasis Recti Abdominis and back pain in postpartum women.

    Six weeks to up to 6 months after birth.

Interventions

2D usg and 3D/4D usgDIAGNOSTIC_TEST

IRD distance measured by a linear probe 2D usg. Pelvic floor muscle morphometry measured by 3D/4D usg

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women from six weeks to up to 6 months after birth, age over 18 years old.

You may qualify if:

  • Women from six weeks to up to 6 months after birth, age over 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PJ Safarik University

Košice, 04011, Slovakia

Location

Study Officials

  • Rastislav Dudič, PhD

    Department of Gynecology and Obstetrics, Medical Faculty, PJ Safarik University, Kosice, Slovakia

    PRINCIPAL INVESTIGATOR

  • Magdalena Hagovska, Prof,PhD

    KFBLR, Medical Faculty, PJ Safarik University, Kosice, Slovakia

    STUDY DIRECTOR

  • Jan Svihra, Prof,MD,PhD.

    Department of Urology, Institution, Comenius University Bratislava, Slovakia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 21, 2021

Study Start

April 8, 2021

Primary Completion

April 28, 2022

Study Completion

May 23, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)