Clinical trial NCT04154527: Bladder Displacement During Abdominal and Pelvic Floor Exercises
Official title: Bladder Base Displacement During Abdominal and Pelvic Floor Exercises in Postpartum Women Comparing to Nulliparous Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Disorder
Keywords: pelvic floor
abdominal muscles
ultrasonography
postpartum
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants were recruited at the midwife consultation from a Primary Care Health center.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* pregnancy
* caesarean birth
* pelvic Floor disorders
* neurological diseases

Primary outcomes:
measure: Cranial or Caudal bladder base displacement measured in cm during the set of 6 exercises.
timeFrame: between 6 and 12 weeks after birth
measure: Vertical and horizontal bladder neck displacement measured in cm during the set of 6 exercises.
timeFrame: between 6 and 12 weeks after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: University of Castilla-La Mancha
state: Castilla La Mancha
Study officials:
affiliation: University of A Coruña. Faculty of Physiotherapy, Spain
name: Sandra M Martinez, PHD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barton 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.