Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diastasis Recti Abdominis and Abdominal Muscles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397941
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : March 25, 2015
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment
Interrectal Distance Diastasis Recti Dimensions of the Muscles of the Lateral Abdominal Wall Other: Ultrasound

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diastasis Recti Abdominis and Abdominal Muscles in Pregnant and Non-pregnant Women
Study Start Date : December 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. interrectal distance [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. measurement of the abdominal muscles of the lateral abdominal wall by ultrasound. [ Time Frame: baseline ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397941


Locations
Layout table for location information
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Nina Kimmich, MD University of Zurich
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02397941    
Other Study ID Numbers: KEK-ZH-Nr.2015-0008
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Diastasis, Muscle
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries