Postpartum DisorderNCT04154527
Bladder Displacement During Abdominal and Pelvic Floor Exercises
An observational study of Postpartum Disorder, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
This study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Disorder
- What is being tested?
- Pelvic Floor and Abdominal Exercises
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2017to Nov 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 Any age
- Women only
- Child, Adult, Older adult
Study population: participants were recruited at the midwife consultation from a Primary Care Health center.
Who may be able to join
- women at postpartum period (more than 6 and less than 12 weeks after vaginal birth)
- willingness to participate in the study
- ability to contract Pelvic Floor Muscles correctly
- written consent to participate.
Who cannot join
- pregnancy
- caesarean birth
- pelvic Floor disorders
- neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bladder Base Displacement During Abdominal and Pelvic Floor Exercises in Postpartum Women Comparing to Nulliparous Women
This study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women
Read the detailed description
Postpartum women are at increased risk of suffering pelvic floor dysfunctions. However, only a few researches are focused on the exercises physiological effect at the postpartum recovery period.
A prospective observational study was designed to evaluate the protective or the prolapsed effect of abdominal and pelvic floor exercises in postpartum women.
Two groups were established: Group A was composed of primiparous women during postpartum period and group B of nulliparous women. Both groups practiced the same set of 6 abdominal and perineum exercises. The bladder descent was registered by ultrasonography, and the correct execution was controlled in both groups by superficial pelvic floor and abdominal electromyography.
A Graphical User Interface on MATLAB software has been developed for aiding in offline measurement process.
- Conditions
- Postpartum Disorder
- Being tested
- Pelvic Floor and Abdominal Exercises
- Keywords
- pelvic floor, abdominal muscles, ultrasonography, postpartum
- Medical subject headings
- Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor and Abdominal ExercisesOther
two repetitions of each exercise, during exhalation phase
| Study group | Role | What they receive |
|---|---|---|
| postpartum women with no pelvic floor disorders | This group realised a set of 6 abdominal and pelvic floor exercises, with a muscle recruitment of 25% of maximum force.
Exercise A: Pelvic Floor contraction Exercise B: Pelvic Floor and Deep Abdominal muscles contraction Exercise C: Pelvic Floor, Deep Abdominal muscles contraction, and axial Stretching Exercise D: Pelvic Floor, Deep and Superficial Abdominal muscles contraction Exercise E: Abdominal Crunch Exercise Exercise F: Low pressure Abdominal Exercise The correct muscle contraction execution was controlled by superficial pelvic floor and abdominal electromyography.
The bladder base and neck displacement was registered by Transabdominal Ultrasound (TAUS) and Transperineal Ultrasound (TPUS) respectively. To image the bladder base and the bladder neck a 3.5 MHz (megahertz) curved linear array ultrasound transducer was used (LOGIQe Ultrasound,General Electric Healthcare, USA) with the ultrasound unit set in B mode. Receives: Other: Pelvic Floor and Abdominal Exercises | |
| nulliparous women with no pelvic floor disorders | This group realised a set of 6 abdominal and pelvic floor exercises, with a muscle recruitment of 25% of maximum force.
Exercise A: Pelvic Floor contraction Exercise B: Pelvic Floor and Deep Abdominal muscles contraction Exercise C: Pelvic Floor, Deep Abdominal muscles contraction, and axial Stretching Exercise D: Pelvic Floor, Deep and Superficial Abdominal muscles contraction Exercise E: Abdominal Crunch Exercise Exercise F: Low pressure Abdominal Exercise The correct muscle contraction execution was controlled by superficial pelvic floor and abdominal electromyography.
The bladder base and neck displacement was registered by Transabdominal Ultrasound (TAUS) and Transperineal Ultrasound (TPUS) respectively. To image the bladder base and the bladder neck a 3.5 MHz (megahertz)curved linear array ultrasound transducer was used (LOGIQe Ultrasound,GE eneral Electric Healthcare, USA) with the ultrasound unit set in B mode. Receives: Other: Pelvic Floor and Abdominal Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial or Caudal bladder base displacement measured in cm during the set of 6 exercises.
Cranial or Caudal bladder base displacement during pelvic floor and abdominal exercises, comparing the baseline at rest to the position at 25% of muscle recruitment, in each exercise.
Measured: between 6 and 12 weeks after birth
Vertical and horizontal bladder neck displacement measured in cm during the set of 6 exercises.
Vertical and horizontal displacement of the bladder neck during pelvic floor and abdominal exercises, comparing the baseline at rest to the position at 25% of muscle recruitment in each exercise.
Measured: between 6 and 12 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start2 May 2017
- Primary completion14 Oct 2019
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum DisorderStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra M Martinez, PHD student, Principal investigator, University of A Coruña. Faculty of Physiotherapy, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154527
- Sponsor's protocol ID
- 2014/610
- Status last verified
- Mar 2020
- First submitted
- 1 Nov 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the individual participant data that underlie results in a publication
Publications
Thompson JA, O'Sullivan PB, Briffa NK, Neumann P. Comparison of transperineal and transabdominal ultrasound in the assessment of voluntary pelvic floor muscle contractions and functional manoeuvres in continent and incontinent women. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jul;18(7):779-86. doi: 10.1007/s00192-006-0225-4. Epub 2006 Oct 17.
PubMed 17043739Barton 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 26215905
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Base Displacement During Abdominal and Pelvic Floor Exercises in Postpartum Women Comparing to Nulliparous Women
- ClinicalTrials.gov ID
- NCT04154527
- Acronym / sponsor ID
- 2014/610
- Conditions
- Postpartum Disorder
- Keywords
- pelvic floor, abdominal muscles, ultrasonography, postpartum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- Nov 2020 (estimated)
- First posted
- 6 Nov 2019 (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.
This study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women
Detailed description
Postpartum women are at increased risk of suffering pelvic floor dysfunctions. However, only a few researches are focused on the exercises physiological effect at the postpartum recovery period.
A prospective observational study was designed to evaluate the protective or the prolapsed effect of abdominal and pelvic floor exercises in postpartum women.
Two groups were established: Group A was composed of primiparous women during postpartum period and group B of nulliparous women. Both groups practiced the same set of 6 abdominal and perineum exercises. The bladder descent was registered by ultrasonography, and the correct execution was controlled in both groups by superficial pelvic floor and abdominal electromyography.
A Graphical User Interface on MATLAB software has been developed for aiding in offline measurement process.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postpartum women with no pelvic floor disorders | – | Other: Pelvic Floor and Abdominal ExercisesThis group realised a set of 6 abdominal and pelvic floor exercises, with a muscle recruitment of 25% of maximum force. Exercise A: Pelvic Floor contraction Exercise B: Pelvic Floor and Deep Abdominal muscles contraction Exercise C: Pelvic Floor, Deep Abdominal muscles contraction, and axial Stretching Exercise D: Pelvic Floor, Deep and Superficial Abdominal muscles contraction Exercise E: Abdominal Crunch Exercise Exercise F: Low pressure Abdominal Exercise The correct muscle contraction execution was controlled by superficial pelvic floor and abdominal electromyography. The bladder base and neck displacement was registered by Transabdominal Ultrasound (TAUS) and Transperineal Ultrasound (TPUS) respectively. To image the bladder base and the bladder neck a 3.5 MHz (megahertz) curved linear array ultrasound transducer was used (LOGIQe Ultrasound,General Electric Healthcare, USA) with the ultrasound unit set in B mode. |
| nulliparous women with no pelvic floor disorders | – | Other: Pelvic Floor and Abdominal ExercisesThis group realised a set of 6 abdominal and pelvic floor exercises, with a muscle recruitment of 25% of maximum force. Exercise A: Pelvic Floor contraction Exercise B: Pelvic Floor and Deep Abdominal muscles contraction Exercise C: Pelvic Floor, Deep Abdominal muscles contraction, and axial Stretching Exercise D: Pelvic Floor, Deep and Superficial Abdominal muscles contraction Exercise E: Abdominal Crunch Exercise Exercise F: Low pressure Abdominal Exercise The correct muscle contraction execution was controlled by superficial pelvic floor and abdominal electromyography. The bladder base and neck displacement was registered by Transabdominal Ultrasound (TAUS) and Transperineal Ultrasound (TPUS) respectively. To image the bladder base and the bladder neck a 3.5 MHz (megahertz)curved linear array ultrasound transducer was used (LOGIQe Ultrasound,GE eneral Electric Healthcare, USA) with the ultrasound unit set in B mode. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- participants were recruited at the midwife consultation from a Primary Care Health center.
Key inclusion criteria (4 listed)
- women at postpartum period (more than 6 and less than 12 weeks after vaginal birth)
- willingness to participate in the study
- ability to contract Pelvic Floor Muscles correctly
- written consent to participate.
Key exclusion criteria (4 listed)
- pregnancy
- caesarean birth
- pelvic Floor disorders
- neurological diseases
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 |
|---|---|---|
| Pelvic Floor and Abdominal Exercisestwo repetitions of each exercise, during exhalation phase | Other | nulliparous women with no pelvic floor disorders, postpartum women with no pelvic floor disorders |
Primary outcome
Cranial or Caudal bladder base displacement measured in cm during the set of 6 exercises.
Time frame: between 6 and 12 weeks after birth
Cranial or Caudal bladder base displacement during pelvic floor and abdominal exercises, comparing the baseline at rest to the position at 25% of muscle recruitment, in each exercise.
Vertical and horizontal bladder neck displacement measured in cm during the set of 6 exercises.
Time frame: between 6 and 12 weeks after birth
Vertical and horizontal displacement of the bladder neck during pelvic floor and abdominal exercises, comparing the baseline at rest to the position at 25% of muscle recruitment in each exercise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 17043739Thompson JA, O'Sullivan PB, Briffa NK, Neumann P. Comparison of transperineal and transabdominal ultrasound in the assessment of voluntary pelvic floor muscle contractions and functional manoeuvres in continent and incontinent women. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jul;18(7):779-86. doi: 10.1007/s00192-006-0225-4. Epub 2006 Oct 17.
- Background: PubMed 26215905Barton 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.
- Individual participant dataSharing planned: Yes. All the individual participant data that underlie results in a publication
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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.
Sandra M Martinez, PHD student principal investigator
University of A Coruña. Faculty of Physiotherapy, Spain
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 Postpartum Disorder, run by University of Castilla-La Mancha 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 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 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?
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?
Cranial or Caudal bladder base displacement measured in cm during the set of 6 exercises. (time frame: between 6 and 12 weeks after birth). The study lists 2 primary outcomes in all. 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 NCT04154527, which also lists 2 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 17 Mar 2020.