Study Stopped
Insufficient recruitment
Diastasis Recti Abdominis and Abdominal Muscles
1 other identifier
observational
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2015
Longer than P75 for all trials
1 active site
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
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 19, 2020
March 1, 2020
4.3 years
March 13, 2015
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
interrectal distance
baseline
Secondary Outcomes (1)
measurement of the abdominal muscles of the lateral abdominal wall by ultrasound.
baseline
Study Arms (3)
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
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
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)
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- abdominal pre-operations
- chronical lung diseases
- constipation
- maternal collagenosis
- polyhydramnion (AFI \> 25)
- uterus fibroids \> 10 cm
- inability to perform Valsalva
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, 8091, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Kimmich, MD
University of Zurich
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 25, 2015
Study Start
December 1, 2015
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
March 19, 2020
Record last verified: 2020-03