Interrectal DistanceNCT02397941
Diastasis Recti Abdominis and Abdominal Muscles
An observational study of Interrectal Distance and Diastasis Recti, run by University of Zurich at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interrectal Distance, Diastasis Recti, Dimensions of the Muscles of the Lateral Abdominal Wall
- What is being tested?
- Ultrasound
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- abdominal pre-operations
- chronical lung diseases
- constipation
- maternal collagenosis
- polyhydramnion (AFI > 25)
- uterus fibroids > 10 cm
- inability to perform Valsalva
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Interrectal Distance, Diastasis Recti, Dimensions of the Muscles of the Lateral Abdominal Wall
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
ultrasound measures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 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 Receives: Other: Ultrasound | |
| 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) Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
interrectal distance
Measured: baseline
Secondary outcomes (1)
measurement of the abdominal muscles of the lateral abdominal wall by ultrasound.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interrectal DistanceStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Kimmich, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397941
- Sponsor's protocol ID
- KEK-ZH-Nr.2015-0008
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2015
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastasis Recti Abdominis and Abdominal Muscles in Pregnant and Non-pregnant Women
- ClinicalTrials.gov ID
- NCT02397941
- Acronym / sponsor ID
- KEK-ZH-Nr.2015-0008
- Conditions
- Interrectal Distance, Diastasis Recti, Dimensions of the Muscles of the Lateral Abdominal Wall
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-pregnant women | – | Other: Ultrasound20 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 | – | Other: Ultrasound40 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 | – | Other: Ultrasound20 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) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- abdominal pre-operations
- chronical lung diseases
- constipation
- maternal collagenosis
- polyhydramnion (AFI > 25)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasoundultrasound measures | Other | non-pregnant women, pregnant women, women who deliverd |
Primary outcome
interrectal distance
Time frame: baseline
1 secondary outcome
measurement of the abdominal muscles of the lateral abdominal wall by ultrasound.
Time frame: baseline
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Kimmich, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interrectal Distance and Diastasis Recti, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interrectal distance (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020; AzTrials last refreshed its copy on 4 Nov 2026.