Diastasis RectiNCT04519840
Diastasis Recti Abdominis Association With Sacroiliac Joint and Pelvic Floor Dysfunction in Postpartum C-section Women
An observational study of Diastasis Recti and Sacroiliac Joint Somatic Dysfunction, run by Dubai Health Authority at 1 site in United Arab Emirates.
Trial summary
Purpose: The purpose of the proposed study is to examine the ability of diastasis recti abdominis to predict outcomes of Sacroiliac joint dysfunction and pelvic floor dysfunction. Sample: The study will use a purposive sampling to select 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diastasis Recti, Sacroiliac Joint Somatic Dysfunction, Pelvic Floor Disorders
- What is being tested?
- nill
- How many people
- 32 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Dec 2020to 1 Aug 2021
- How long will I take part?
- 1 Day
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: • The study will use a purposive sampling of 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. All subjects will live in the United Arab Emirates minimum of 6 months prior to taking part in the study.
Who may be able to join
- Eligible participant should be 12-48 weeks postpartum between ages of 18-45 years
- Maximum two Cesarean section delivery with no vaginal deliveries.
Who cannot join
- ● Participant will be excluded (identified with the assistance of a health screening questionnaire):
- History of traumatic injury to the lumbar-pelvic region, hip or lower extremities
- Morbid Obesity: Participants with more than 35 kg/m2 body mass index will be excluded.
- History of systemic disease affecting the musculoskeletal, neuromuscular and cardiopulmonary systems
- Cardiovascular disease affecting lung function.
- History of traumatic injury to the lumbar-pelvic region, hip or lower extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross Sectional Study to Determine the Association Between Diastasis Recti Abdominis and Sacroiliac Joint and Pelvic Floor Dysfunction Outcomes Among Postpartum Women Who Underwent C-section in UAE
Purpose: The purpose of the proposed study is to examine the ability of diastasis recti abdominis to predict outcomes of Sacroiliac joint dysfunction and pelvic floor dysfunction.
- Sample: The study will use a purposive sampling to select 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. All subjects should have resided in the UAE minimum of 6 months prior to taking part in the study.
Read more
Data analysis:
- The age range of the subjects as well as the mean age with standard deviation will be determined.
- Data will be analyzed using Multivariate Linear Regression Analysis for the primary research question.
- For the Ssecondary research questions will include difference in DRA will be analyzed byas below:
- SIJ Dysfunction (logistic regression-Odds ratio)
- PFDI (Low, Moderate, High) (ANOVA/Kruskal Wallace Wallis Test)
- Pelvic Fascia excursion (Low, Moderate, High). (ANOVA/Kruskal Wallace Wallis Test)
Read the detailed description
The data recorded for each subject will include: medical record number (MRN), type of delivery, measurement values and presence or absence of DRA as well as general health information collected in the health screening questionnaire. All identifiers will be kept separately , and password protected only accessed by Primary Investigator. Unless required by law or in the event of medical emergency, MRN of any subject will not be disclosed to anyone by the investigator. Under no circumstances will the personal identity of any subject be revealed in any form of a publication or presentation.
With the exception of the subject's medical record number as well as signed forms (consent and health questionnaire), all recorded study data will be identified using only a unique number for each subject. A paper master list will be kept that matches each medical record number to their identification number and kept in a separate locked and secured cabinet from the rest of the data. Other than that, the signed forms, all other data will be recorded initially on a paper sheet then transferred to an electronic spreadsheet. When not under direct supervision of the investigator, all paper records will be kept secure in locked filing cabinets, accessible only to the investigator. All data stored electronically will be maintained and backed up in an encrypted format with the password known only to the investigator. Subjects will be provided with a photocopy of the signed consent form.
- Being tested
- nill
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nillOther
nill
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of Diastasis Recti Abdominus
Primary outcome
Measured: 48 weeks
Secondary outcomes (2)
sacroiliac joint somatic dysfunction
Secondary outcome
Measured: 48 weeks
Pelvic floor disorder
secondary outcome
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start15 Dec 2020
- Primary completion1 Mar 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dubai Health Authority
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Enas Mohammad Taher Abu Saleh, Dubai Health Authority
- Investigators
- Meeyoung Kim, PhD, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519840
- Sponsor's protocol ID
- DubaiHA
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: f prediction association is evident between diastasis recti abdominis and sacroiliac joint dysfuction medical record number and measurement scores will be used for further analysis for providing an experimental study. In which intervention will be applied for diastasis recti abdominis and observing the effect of that at sacroiliac joint dysfunction.
Publications
Sperstad JB, Tennfjord MK, Hilde G, Ellstrom-Engh M, Bo K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20.
PubMed 27324871Ostgaard HC, Roos-Hansson E, Zetherstrom G. Regression of back and posterior pelvic pain after pregnancy. Spine (Phila Pa 1976). 1996 Dec 1;21(23):2777-80. doi: 10.1097/00007632-199612010-00013.
PubMed 8979325Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536.
PubMed 27363572Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
PubMed 18259783Broadhurst NA, Bond MJ. Pain provocation tests for the assessment of sacroiliac joint dysfunction. J Spinal Disord. 1998 Aug;11(4):341-5.
PubMed 9726305Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.
PubMed 16038856Vleeming A, de Vries HJ, Mens JM, van Wingerden JP. Possible role of the long dorsal sacroiliac ligament in women with peripartum pelvic pain. Acta Obstet Gynecol Scand. 2002 May;81(5):430-6. doi: 10.1034/j.1600-0412.2002.810510.x.
PubMed 12027817Freburger JK, Riddle DL. Using published evidence to guide the examination of the sacroiliac joint region. Phys Ther. 2001 May;81(5):1135-43. No abstract available.
PubMed 11319939O'Sullivan PB, Beales DJ, Beetham JA, Cripps J, Graf F, Lin IB, Tucker B, Avery A. Altered motor control strategies in subjects with sacroiliac joint pain during the active straight-leg-raise test. Spine (Phila Pa 1976). 2002 Jan 1;27(1):E1-8. doi: 10.1097/00007632-200201010-00015.
PubMed 11805650Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.
PubMed 24982755Mota P, Pascoal AG, Sancho F, Bo K. Test-retest and intrarater reliability of 2-dimensional ultrasound measurements of distance between rectus abdominis in women. J Orthop Sports Phys Ther. 2012 Nov;42(11):940-6. doi: 10.2519/jospt.2012.4115. Epub 2012 Jul 18.
PubMed 22810966Chiarello CM, McAuley JA. Concurrent validity of calipers and ultrasound imaging to measure interrecti distance. J Orthop Sports Phys Ther. 2013;43(7):495-503. doi: 10.2519/jospt.2013.4449. Epub 2013 Apr 30.
PubMed 23633625Butowicz CM, Ebaugh DD, Noehren B, Silfies SP. VALIDATION OF TWO CLINICAL MEASURES OF CORE STABILITY. Int J Sports Phys Ther. 2016 Feb;11(1):15-23.
PubMed 26900496Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28.
PubMed 26215905Fonseca H, Silva AM, Matos MG, Esteves I, Costa P, Guerra A, Gomes-Pedro J. Validity of BMI based on self-reported weight and height in adolescents. Acta Paediatr. 2010 Jan;99(1):83-8. doi: 10.1111/j.1651-2227.2009.01518.x.
PubMed 19878130
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study to Determine the Association Between Diastasis Recti Abdominis and Sacroiliac Joint and Pelvic Floor Dysfunction Outcomes Among Postpartum Women Who Underwent C-section in UAE
- ClinicalTrials.gov ID
- NCT04519840
- Acronym / sponsor ID
- DubaiHA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dubai Health AuthorityOther government
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- 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: The purpose of the proposed study is to examine the ability of diastasis recti abdominis to predict outcomes of Sacroiliac joint dysfunction and pelvic floor dysfunction.
- Sample: The study will use a purposive sampling to select 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. All subjects should have resided in the UAE minimum of 6 months prior to taking part in the study.
Data analysis:
- The age range of the subjects as well as the mean age with standard deviation will be determined.
- Data will be analyzed using Multivariate Linear Regression Analysis for the primary research question.
- For the Ssecondary research questions will include difference in DRA will be analyzed byas below:
- SIJ Dysfunction (logistic regression-Odds ratio)
- PFDI (Low, Moderate, High) (ANOVA/Kruskal Wallace Wallis Test)
- Pelvic Fascia excursion (Low, Moderate, High). (ANOVA/Kruskal Wallace Wallis Test)
Detailed description
The data recorded for each subject will include: medical record number (MRN), type of delivery, measurement values and presence or absence of DRA as well as general health information collected in the health screening questionnaire. All identifiers will be kept separately , and password protected only accessed by Primary Investigator. Unless required by law or in the event of medical emergency, MRN of any subject will not be disclosed to anyone by the investigator. Under no circumstances will the personal identity of any subject be revealed in any form of a publication or presentation.
With the exception of the subject's medical record number as well as signed forms (consent and health questionnaire), all recorded study data will be identified using only a unique number for each subject. A paper master list will be kept that matches each medical record number to their identification number and kept in a separate locked and secured cabinet from the rest of the data. Other than that, the signed forms, all other data will be recorded initially on a paper sheet then transferred to an electronic spreadsheet. When not under direct supervision of the investigator, all paper records will be kept secure in locked filing cabinets, accessible only to the investigator. All data stored electronically will be maintained and backed up in an encrypted format with the password known only to the investigator. Subjects will be provided with a photocopy of the signed consent form.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- • The study will use a purposive sampling of 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. All subjects will live in the United Arab Emirates minimum of 6 months prior to taking part in the study.
Key inclusion criteria (2 listed)
- Eligible participant should be 12-48 weeks postpartum between ages of 18-45 years
- Maximum two Cesarean section delivery with no vaginal deliveries.
Key exclusion criteria (6 listed)
- ● Participant will be excluded (identified with the assistance of a health screening questionnaire):
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 |
|---|---|---|
| nillnill | Other | – |
Primary outcome
presence of Diastasis Recti Abdominus
Time frame: 48 weeks
Primary outcome
2 secondary outcomes
sacroiliac joint somatic dysfunction
Time frame: 48 weeks
Pelvic floor disorder
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 27324871Sperstad JB, Tennfjord MK, Hilde G, Ellstrom-Engh M, Bo K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20.
- Background: PubMed 8979325Ostgaard HC, Roos-Hansson E, Zetherstrom G. Regression of back and posterior pelvic pain after pregnancy. Spine (Phila Pa 1976). 1996 Dec 1;21(23):2777-80. doi: 10.1097/00007632-199612010-00013.
- Background: PubMed 27363572Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536.
- Background: PubMed 18259783Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
- Background: PubMed 9726305Broadhurst NA, Bond MJ. Pain provocation tests for the assessment of sacroiliac joint dysfunction. J Spinal Disord. 1998 Aug;11(4):341-5.
- Background: PubMed 16038856Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.
- Background: PubMed 12027817Vleeming A, de Vries HJ, Mens JM, van Wingerden JP. Possible role of the long dorsal sacroiliac ligament in women with peripartum pelvic pain. Acta Obstet Gynecol Scand. 2002 May;81(5):430-6. doi: 10.1034/j.1600-0412.2002.810510.x.
- Background: PubMed 11319939Freburger JK, Riddle DL. Using published evidence to guide the examination of the sacroiliac joint region. Phys Ther. 2001 May;81(5):1135-43. No abstract available.
- Background: PubMed 11805650O'Sullivan PB, Beales DJ, Beetham JA, Cripps J, Graf F, Lin IB, Tucker B, Avery A. Altered motor control strategies in subjects with sacroiliac joint pain during the active straight-leg-raise test. Spine (Phila Pa 1976). 2002 Jan 1;27(1):E1-8. doi: 10.1097/00007632-200201010-00015.
- Background: PubMed 24982755Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.
- Background: PubMed 22810966Mota P, Pascoal AG, Sancho F, Bo K. Test-retest and intrarater reliability of 2-dimensional ultrasound measurements of distance between rectus abdominis in women. J Orthop Sports Phys Ther. 2012 Nov;42(11):940-6. doi: 10.2519/jospt.2012.4115. Epub 2012 Jul 18.
- Background: PubMed 23633625Chiarello CM, McAuley JA. Concurrent validity of calipers and ultrasound imaging to measure interrecti distance. J Orthop Sports Phys Ther. 2013;43(7):495-503. doi: 10.2519/jospt.2013.4449. Epub 2013 Apr 30.
- Individual participant dataSharing planned: Yes. f prediction association is evident between diastasis recti abdominis and sacroiliac joint dysfuction medical record number and measurement scores will be used for further analysis for providing an experimental study. In which intervention will be applied for diastasis recti abdominis and observing the effect of that at sacroiliac joint dysfunction.
Related trials for Diastasis Recti
Recruiting
Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Diastasis Recti Abdominis, Abdominal Wall Laxity
Recruiting
Effects of Corrective Versus Plank Exercises on Diastasis Recti
Diastasis Recti
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
Diastasis Recti
Recruiting
Risk Factors and Exercise Effects on Abdominal Separation in Seniors
Diastasis Recti Abdominis (DRA), Aging
Active, not recruiting
Comparative Effects of Telerehabilitation Versus In-Person Core Stability Training in Postpartum Women
Postpartum, Diastasis Recti Abdominis (DRA)
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.
Meeyoung Kim, PhD principal investigator
University of Sharjah
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 Diastasis Recti and Sacroiliac Joint Somatic Dysfunction, run by Dubai Health Authority at 1 site in United Arab Emirates.
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 6 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: finished, as of the sponsor's last update on 18 Aug 2021. 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 United Arab Emirates. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
presence of Diastasis Recti Abdominus (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519840, which also lists 20 linked publications.
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 18 Aug 2021.