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Trial registered on ANZCTR


Registration number
ACTRN12619000867190
Ethics application status
Approved
Date submitted
11/02/2019
Date registered
18/06/2019
Date last updated
18/06/2019
Date data sharing statement initially provided
18/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery of the pelvic floor in the postpartum period
Scientific title
Evaluation of the effectiveness of a program to strengthen the pelvic floor of women in the postpartum period
Secondary ID [1] 297053 0
none
Universal Trial Number (UTN)
U1111-1226-6747
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum 311050 0
urinary incontinence 311051 0
pelvic floor recovery 311052 0
Condition category
Condition code
Reproductive Health and Childbirth 309688 309688 0 0
Childbirth and postnatal care
Renal and Urogenital 310842 310842 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (Control): Perform standardized pelvic floor exercises (PFMT),
designed by the physiotherapy team that will participate in the study, following the
current clinical practice guidelines and determining a duration of at least 12
weeks for the completion of the exercises.
Group 2 (Intervention-a): Perform the pelvic floor exercises established by the
physiotherapy equipment while using the vaginal spheres. The duration of it
They will also be 12 weeks.
Group 3 (Intervention-b): they will use the vaginal spheres in their life activities
daily during the 12 weeks of the intervention and intensively, according to the
program determined by the physiotherapy team that will participate in the study.

- material used: Group 2 and 3 will use one vaginal ball (24gr) during the intervention
- procedures/activities/exercices: Pelvic floor Muscle training (PFMT) exercices,
designed by the physiotherapy team
- who will deliver the intervention: the midwifes and the physiotherapist in charge of the program
- the mode of delivery: group 1 and 2 will assist to one class per week and subsequently will apply the new exercises learned in the class, at home during the next week.
- frequency: group 1 and 2 will do twice a day exercises at home (10 minutes in the morning + 10 minutes in the afternoon) Group 3 will do their daily life activities with the vaginal balls during 20 minutes per day (preferably in the mornings)
- We will use whatsapp groups to monitor the adherence to the treatment.
Intervention code [1] 313329 0
Rehabilitation
Comparator / control treatment

• Group 1 (Control) = PFMT would perform the exercises exclusively designed by the team of Physiotherapy participating in the study.

• Group 2 (Intervention-a) = PFMT would perform exercises with the use of vaginal spheres.

• Group 3 (Intervention-b) = would perform intensive treatment, designed for physiotherapy equipment vaginal areas.
Control group
Active

Outcomes
Primary outcome [1] 319010 0
- Effectiveness of the pelvic floor muscle training meassured by Perineometer and modified Oxford test.
Timepoint [1] 319010 0
1st measurement prior the intervention, 2nd one week post intervention.
Secondary outcome [1] 366704 0
- Quality of life as assessed by King's Health Questionnaire (KHQ- spanish version 2013)
Timepoint [1] 366704 0
1st measurement prior the intervention, 2nd one week post intervention.
Secondary outcome [2] 369472 0
Sexual satisfaction as assessed by Female Sexual Function Index (FSFI)
Timepoint [2] 369472 0
1st measurement prior the intervention, 2nd one week post intervention.

Eligibility
Key inclusion criteria
- Primiparous women.
- Women who are in the postpartum period between 6 weeks (quarantine) and 6
months at the start of the intervention.
- Newborn births Term (from 37 weeks)
- Cease Lochia.
- Sufficient knowledge of the Spanish language, both written and spoken.
- Acceptance to participate in the study through informed consent.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Multiparous women
- Women off limits postpartum (previous birth to 6 months after surgery)
- Women undergoing treatment of lower urinary tract (ITU treatment)
- Women who are already participating in a recovery program pelvic floor.
- Women with tear III and IV grade.
- Pregnant (or become pregnant approach in the intervention period) Women
- Starting point pelvic floor muscle balance women less than 2 points. (Where
retention vaginal areas impossible)
- Inability to perform the necessary procedures for intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be a Controlled and Randomized Clinical Trial, single-blind (Technical
opaque envelopes), with three parallel groups for intervention and subsequent
comparison:
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (GP.Power programme in version 3.1.9.2.) In which we will apply an effect size of 0.8, comparing in parallel the three focus groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
After a scan statistic of the data input to detect errors in the base, the same will be
described as the three study groups. Quantitative variables are expressed in means
and standard or medians and 25th and 75th percentiles, if skewed distributions
deviations, and qualitative variables with frequency and percentage.
Next, an analysis of baseline comparability between the two groups will be performed.
for analyse the relationships between qualitative variables, contingency tables will be
made and the Chi-square test or non-asymptotic test methods and Monte Carlo exact
test will be applied.
To see if there are differences in average of numerical variables between the two
groups, T-Student's test will be used for independent samples or Mann-Whitney-U
Test for non-normal distributions. Significant mean differences will be quantified with
confidence intervals at 95% and, if not normal, the differences between medians with
confidence intervals Hodges-Lehman 95%.
Furthermore, to contrast changes in a numerical parameter measured at different time
points (possible intra-intervention assessments) within each group, the Friedman Test
or the nonparametric Wilcoxon Test is applied in the case of only two moments. The
change between two time points of a qualitative variable is analysed with the
McNemar Test.
The data analysis will be performed with the statistical program SPSS 23.0 for
Windows.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2019
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment outside Australia
Country [1] 21271 0
Spain
State/province [1] 21271 0
Sevilla

Funding & Sponsors
Funding source category [1] 301624 0
University
Name [1] 301624 0
Universidad de Sevilla
Country [1] 301624 0
Spain
Primary sponsor type
Hospital
Name
Hospital Nuestra Señora de la Merced (Osuna)
Address
Hospital Ntra Sra de la Merced.
Avda. de la Constitución nº2, Cp. 41640. Osuna, Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 301327 0
University
Name [1] 301327 0
Universidad de Sevilla
Address [1] 301327 0
Facultad de enfermería, fisioterapia y podología. Universidad de Sevilla. Calle Avenzoar, 6, 41009 Sevilla (Spain)
Country [1] 301327 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302349 0
Portal Etica de la Investigacion Biomedica en Andalucia (PEIBA)
Ethics committee address [1] 302349 0
Ethics committee country [1] 302349 0
Spain
Date submitted for ethics approval [1] 302349 0
02/07/2018
Approval date [1] 302349 0
02/09/2018
Ethics approval number [1] 302349 0
12d251885e24d75006edb0446fe36b739d8d3336

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89914 0
Miss ELISA HERNANDEZ LLORENTE
Address 89914 0
Facultad de Enfermeria, Fisioterapia y Podología. Universidad de Sevilla Calle Avenzoar, 6. CP.41009 Sevilla, Spain.
Country 89914 0
Spain
Phone 89914 0
+34 646249153
Fax 89914 0
Email 89914 0
[email protected]
Contact person for public queries
Name 89915 0
ELISA HERNANDEZ LLORENTE
Address 89915 0
Facultad de Enfermeria, Fisioterapia y Podología. Universidad de Sevilla Calle Avenzoar, 6. CP.41009 Sevilla, Spain.
Country 89915 0
Spain
Phone 89915 0
+34 646249153
Fax 89915 0
Email 89915 0
[email protected]
Contact person for scientific queries
Name 89916 0
ELISA HERNANDEZ LLORENTE
Address 89916 0
Facultad de Enfermeria, Fisioterapia y Podología. Universidad de Sevilla Calle Avenzoar, 6. CP.41009 Sevilla, Spain.
Country 89916 0
Spain
Phone 89916 0
+34 646249153
Fax 89916 0
Email 89916 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• all of the individual participant data collected during the trial, after de-identification

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator,

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1334Ethical approval    Study-related document.pdf
1335Study protocol    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.