Diastasis Recti Abdominis and Abdominal Muscles

March 17, 2020 updated by: University of Zurich

Diastasis Recti Abdominis and Abdominal Muscles in Pregnant and Non-pregnant Women

Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  • Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women
  • Assessment via ultrasound measurement transabdominally
  • 3 groups of participants: 1.) 20 pregnant women, who have never been pregnant before; 2.) 40 pregnant women with their first pregnancy, followed over the course of pregnancy; 3.) 20 women1-5 days after delivery (10 after spontaneous delivery, 10 after planned cesarean section)
  • comparison between pregnant and non-pregnant women; evaluation of influence of pregnancy and mode of delivery

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Inclusion:

  • non-pregnant women aged 20-45 y with a BMI < 30 kg/m2 who never were pregnant
  • pregnant women aged 20-45 y with a BMI < 30 kg/m2 before pregnancy

Description

Inclusion Criteria:

  • non-pregnant women aged 20-45 y with a BMI < 30 kg/m2 who never were pregnant
  • pregnant women aged 20-45 y with a BMI < 30 kg/m2 before pregnancy

Exclusion Criteria:

  • abdominal pre-operations
  • chronical lung diseases
  • constipation
  • maternal collagenosis
  • polyhydramnion (AFI > 25)
  • uterus fibroids > 10 cm
  • inability to perform Valsalva

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-pregnant women
20 non-pregnant women, BMI < 30 kg/m2, Nulligravidas, no abdominal pre-operations, aged 20-45 years, measurement of the abdominal muscles and interrectal distance by ultrasound
Other: Ultrasound
ultrasound measures
pregnant women
40 pregnant women, BMI < 30 kg/m2 before pregnancy, Primigravidas, no abdominal pre-operations, aged 20-45 years, measurement of the abdominal muscles and interrectal distance by ultrasound, consecutive measurement during the course of pregnancy
Other: Ultrasound
ultrasound measures
women who deliverd
20 pregnant women, BMI < 30 kg/m2 before pregnancy, Primiparas, no abdominal pre-operations, aged 20-45 years, measurement of the abdominal muscles and interrectal distance by ultrasound, measurement after delivery (10 after spontaneous delivery, 10 after elective cesarean section)
Other: Ultrasound
ultrasound measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
interrectal distance
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
measurement of the abdominal muscles of the lateral abdominal wall by ultrasound.
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Nina Kimmich, MD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr.2015-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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