ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

U1111-1226-6747

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

postpartum

urinary incontinence

pelvic floor recovery

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Renal and Urogenital

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]

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]

- Effectiveness of the pelvic floor muscle training meassured by Perineometer and modified Oxford test.

Timepoint [1]

1st measurement prior the intervention, 2nd one week post intervention.

Secondary outcome [1]

- Quality of life as assessed by King's Health Questionnaire (KHQ- spanish version 2013)

Timepoint [1]

1st measurement prior the intervention, 2nd one week post intervention.

Secondary outcome [2]

Sexual satisfaction as assessed by Female Sexual Function Index (FSFI)

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Sevilla

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universidad de Sevilla

Address [1]

Facultad de enfermería, fisioterapia y podología. Universidad de Sevilla.
Calle Avenzoar, 6, 41009 Sevilla (Spain)

Country [1]

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]

University

Name [1]

Universidad de Sevilla

Address [1]

Facultad de enfermería, fisioterapia y podología. Universidad de Sevilla.
Calle Avenzoar, 6, 41009 Sevilla (Spain)

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Portal Etica de la Investigacion Biomedica en Andalucia (PEIBA)

Ethics committee address [1]

Consejería de Salud Avenida de la Constitución Nº18, 41001 Sevilla (Spain)

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

02/07/2018

Approval date [1]

02/09/2018

Ethics approval number [1]

12d251885e24d75006edb0446fe36b739d8d3336

Summary

Brief summary

- In order to determine the effectiveness of using vaginal areas for improving the
perineal strength of women in the postpartum period, we have designed a randomized
experimental clinical trial. We will take as a reference population all primiparous
women who give birth in the metropolitan area of Seville, in the course of a year.

- To determine the effectiveness of 3 types of muscle training for recovery pelvic floor
postpartum and evaluate their effectiveness by perineometer, Test and Modified
Oxford ICIQ Incontinence Questionnaire SF.

- Therefore, women in the puerperal period, perform pelvic floor exercises (PFMT) with
vaginal spheres, have more rapid and effective recovery of the perineal strength .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss ELISA HERNANDEZ LLORENTE

Address

Facultad de Enfermeria, Fisioterapia y Podología. Universidad de Sevilla
Calle Avenzoar, 6.
CP.41009
Sevilla, Spain.

Country

Spain

Phone

+34 646249153

Fax

ELISAHDEZLLORENTE@GMAIL.COM

Contact person for public queries

Name

ELISA HERNANDEZ LLORENTE

Address

Facultad de Enfermeria, Fisioterapia y Podología. Universidad de Sevilla
Calle Avenzoar, 6.
CP.41009
Sevilla, Spain.

Country

Spain

Phone

+34 646249153

Fax

ELISAHDEZLLORENTE@GMAIL.COM

Contact person for scientific queries

Name

ELISA HERNANDEZ LLORENTE

Address

Facultad de Enfermeria, Fisioterapia y Podología. Universidad de Sevilla
Calle Avenzoar, 6.
CP.41009
Sevilla, Spain.

Country

Spain

Phone

+34 646249153

Fax

ELISAHDEZLLORENTE@GMAIL.COM

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

all of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

immediately following publication, no end date

Available to whom?

only researchers who provide a methodologically sound proposal

Available for what types of analyses?

any purpose

How or where can data be obtained?

access subject to approvals by Principal Investigator,

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1334	Ethical approval					376714-(Uploaded-11-02-2019-05-18-49)-Study-related document.pdf
1335	Study protocol					376714-(Uploaded-11-02-2019-05-19-35)-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.

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