An observational study in Postpartum Disorder, sponsored by University of Castilla-La Mancha. Status unknown at 1 site in Spain. Open to female participants. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by University of Castilla-La Mancha · Observational
This study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women
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.
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participants were recruited at the midwife consultation from a Primary Care Health center.
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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.
Other: Pelvic Floor and Abdominal Exercises
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.
Other: Pelvic Floor and Abdominal Exercises
two repetitions of each exercise, during exhalation phase
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.
Time frame: 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.
Time frame: between 6 and 12 weeks after birth
Plan to share: Yes — All the individual participant data that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will be available within 6 months after study completion
Access criteria: Data access will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement
Ran from May 2017 to primary completion in Oct 2019, 29 months.
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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