NCT05485844

Brief Summary

The aim of this study was to compare participants with increased symptoms after index pregnancy with those reporting no change in back pain or subjective movement control and analyzed their inter rectus distance (IRD). This study is a case-control study of a cohort of women who had delivered a year earlier. We recruited participants with increased symptoms (n=14) after index pregnancy and controls (n=41) and recorded their inter rectus distance with ultrasound. A questionnaire was filled, and an ultrasound was performed two times for the study groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration 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

January 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

July 27, 2022

Last Update Submit

August 1, 2022

Conditions

Diastasis Recti

Outcome Measures

Primary Outcomes (1)

  • Inter rectus diameter

    Ultra sound measurement of linea alba widht

    A year after index pregnancy

Secondary Outcomes (6)

  • Waiter's bow

    A year after index pregnancy

  • Pelvic tilt

    A year after index pregnancy

  • One leg stance-test

    A year after index pregnancy

  • Active straight leg test

    A year after index pregnancy

  • Sit up test

    A year after index pregnancy

  • +1 more secondary outcomes

Study Arms (2)

Symptomatic

Individuals reporting increased back pain and/or decreased motor control function in a second questionnaire conducted a year after index pregnancy

Controls

Controls reporting no change in their bodily experience between the two questionnaires

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA study is for abdominal rectus diastasis after pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants were enrolled in pregnancy screening unit during the first pregnancy screening ultra sound.

You may qualify if:

  • Age over 18 years

You may not qualify if:

  • Body mass index (BMI) over 28 kg/m2 ( weight and height combined to report BMI in kg/m\^2
  • Ongoing pregnancy during the second questionnaire, a year after the index pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Jorvi Hospital

Espoo, HUS, 00029, Finland

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 3, 2022

Study Start

January 1, 2018

Primary Completion

March 21, 2021

Study Completion

March 21, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)