Recti DiastasisNCT03425916
Changes in Abdominal Muscles Performance in Postpartum Women.
An observational study of Recti Diastasis and Pregnancy Related, run by University of Alcala at 1 site in Spain.
Trial summary
To describe and compare abdominal muscles and inter-rectus distance conditions in postpartum period in comparison with nulliparous women. Also to describe the activation changes during different abdominal exercises. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recti Diastasis, Pregnancy Related
- What is being tested?
- Physical therapy intervention
- How many people
- 196 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 6 May 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primiparous women after normal, not operative, vaginal one-child delivery, recruited 6-7 weeks after delivery from Hospital Universitario Principe de Asturias (Alcala de Henares, Madrid)
Who may be able to join
- Primiparous women
- Normal not operative delivery
- One child delivery
Who cannot join
- Two or more previous gestation
- Previous abdominal surgery
- Systemic disease, neurologic or metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Abdominal Muscles Performance and Inter-rectus Distance in Postpartum Women: an Ultrasonography and Electromyographic Study.
To describe and compare abdominal muscles and inter-rectus distance conditions in postpartum period in comparison with nulliparous women. Also to describe the activation changes during different abdominal exercises.
Read the detailed description
Pregnancy and childbirth cause corporal changes in women, altering the structure and function of the abdominal and pelvic floor muscles. The distension of the muscular tissue and the possible diastasis recti can alter the performance of the abdominal musculature in the control of intra-abdominal pressure and the lumbo-pelvic stabilization in postpartum term. Abdominal exercise is highly recommended to restore these changes but there is not enough evidence about the effects of exercise modalities.
- Conditions
- Recti Diastasis, Pregnancy Related
- Being tested
- Physical therapy intervention
- Keywords
- Hypopressive exercises, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy interventionOther
Primiparous women start a physical therapy intervention in week 6 after normal one-child delivery, based on abdominal and pelvic floor exercises, education and behavior advices. Abdominal muscle condition and activation are measured by transabdominal ultrasound and surface electromiography. This group is going to be examined after treatment and 6 and 12 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Primiparous women | Women after normal, not operative, vaginal one-child delivery Receives: Other: Physical therapy intervention | |
| Nulliparous women | Women without any child or pregnancy, age-matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rectus distance (mm)
Inter-rectus abdominis distance in mm in rest position.
Measured: 1 day
Secondary outcomes (3)
Cross-sectional area (mm)
Cross-sectional area of rectus abdominis, external oblique, internal oblique and transversus abdominis in rest position.
Measured: 1 day
Neuromuscular activity (mV)
Neuromuscular activity (mV) of rectus abdominis, external oblique and internal oblique + transversus abdominis in rest position.
Measured: 1 day
Inter-rectus distance (mm) during an hypopressive exercise
Inter-rectus distance (mm) during an hypopressive exercise performance in supine position.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Sep 2017
- Primary completion8 Jan 2018
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recti DiastasisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Arranz Martin, University of Alcala
- Investigators
- Maria Torres, PhD, Study director, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425916
- Sponsor's protocol ID
- BAM2018
- Status last verified
- May 2019
- First submitted
- 25 Jan 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Abdominal Muscles Performance and Inter-rectus Distance in Postpartum Women: an Ultrasonography and Electromyographic Study.
- ClinicalTrials.gov ID
- NCT03425916
- Acronym / sponsor ID
- BAM2018
- Conditions
- Recti Diastasis, Pregnancy Related
- Keywords
- Hypopressive exercises, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 8 Feb 2018 (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.
To describe and compare abdominal muscles and inter-rectus distance conditions in postpartum period in comparison with nulliparous women. Also to describe the activation changes during different abdominal exercises.
Detailed description
Pregnancy and childbirth cause corporal changes in women, altering the structure and function of the abdominal and pelvic floor muscles. The distension of the muscular tissue and the possible diastasis recti can alter the performance of the abdominal musculature in the control of intra-abdominal pressure and the lumbo-pelvic stabilization in postpartum term. Abdominal exercise is highly recommended to restore these changes but there is not enough evidence about the effects of exercise modalities.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primiparous women | – | Other: Physical therapy interventionWomen after normal, not operative, vaginal one-child delivery |
| Nulliparous women | – | –Women without any child or pregnancy, age-matched |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primiparous women after normal, not operative, vaginal one-child delivery, recruited 6-7 weeks after delivery from Hospital Universitario Principe de Asturias (Alcala de Henares, Madrid)
Key inclusion criteria (3 listed)
- Primiparous women
- Normal not operative delivery
- One child delivery
Key exclusion criteria (3 listed)
- Two or more previous gestation
- Previous abdominal surgery
- Systemic disease, neurologic or metabolic disease
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 |
|---|---|---|
| Physical therapy interventionPrimiparous women start a physical therapy intervention in week 6 after normal one-child delivery, based on abdominal and pelvic floor exercises, education and behavior advices. Abdominal muscle condition and activation are measured by transabdominal ultrasound and surface electromiography. This group is going to be examined after treatment and 6 and 12 months after treatment. | Other | Primiparous women |
Primary outcome
Inter-rectus distance (mm)
Time frame: 1 day
Inter-rectus abdominis distance in mm in rest position.
3 secondary outcomes
Cross-sectional area (mm)
Time frame: 1 day
Neuromuscular activity (mV)
Time frame: 1 day
Inter-rectus distance (mm) during an hypopressive exercise
Time frame: 1 day
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 7 May 2019.
- Individual participant dataSharing planned: No
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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.
Maria Torres, PhD study director
University of Alcala
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 Recti Diastasis and Pregnancy Related, run by University of Alcala at 1 site in Spain.
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 3 inclusion and 3 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 7 May 2019. 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 Spain. 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?
Inter-rectus distance (mm) (time frame: 1 day). 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 7 May 2019.