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Trial registered on ANZCTR


Registration number
ACTRN12619001733167
Ethics application status
Approved
Date submitted
29/09/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of pelvic floor muscle exercises intervention in improving knowledge, attitude, practice and confidence among pregnant women in Malaysia.
Scientific title
Effectiveness of pelvic floor muscle exercises intervention in improving knowledge, attitude, practice and self-efficacy among pregnant women in Malaysia.
Secondary ID [1] 299389 0
Nil Known
Universal Trial Number (UTN)
U1111-1240-9274
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary incontinence in pregnancy 314632 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312971 312971 0 0
Physiotherapy
Reproductive Health and Childbirth 312973 312973 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received the newly developed pelvic floor muscles exercise (PFME) intervention which developed based on Health Belief Model and Motivational Interviewing in addition to the usual prenatal care. The PFME intervention consisted of single PFME education sessions delivered at baseline, a personalized short text message reminder and three booster sessions at the week 4 post-education session, early third-trimester and late third-trimester. The whole intervention was facilitated by a primary researcher who was a physiotherapist.

The first PFME education session was provided in a group of approximately 4 to 8 persons for about 40 to 45 minutes. During the session, the primary researcher actively engaged in facilitating discussion and providing information on urinary incontinence and PFME based on the perceived susceptibility and severity of UI, perceived benefit of PFME and perceived barriers to adhering to PFME. This session also involved teaching, demonstrating and practicing correct pelvic floor muscle contraction, together with educating on integrating the exercise into daily activities and healthy bladder habit strategies during and following pregnancy.

This was followed by a weekly personalized short message reminder on adherence to PFME for eight week, examples “Remember your target PFME, 8-12 repetitions hold for 6-8 second three time daily" and "Don’t’ give up doing your PFME". The booster sessions took approximately 30 minutes which specifically focused on reinforcing the skills and aims for targeted PFME, discussing experiences, challenges and barriers in practicing PFME and to facilitate the continuous practice of PFME.

The PFME is involves “squeeze with inward and upward lift” movement around urethra, vagina and anus. This exercise targeting to increase the strength, endurance and to improve function of pelvic floor muscles specifically in prevention and treatment of urinary incontinence. The targeted pelvic floor muscles exercise prescription were 8-12 repetitions hold for 6-8 second three time daily” and integrated the exercises into daily activities.
Intervention code [1] 315683 0
Behaviour
Intervention code [2] 316266 0
Treatment: Other
Comparator / control treatment
The control group received the usual perinatal care which consisted of physical examination, health screening, case management and health education, based on the Ministry of Health, Malaysia (MOH) guidelines for pregnant women. The respondents in the control group could also participate in the antenatal and postnatal education, which was usually offered at late third-trimester to pregnant women and during the hospitalized postnatal period.
Control group
Active

Outcomes
Primary outcome [1] 321545 0
The primary outcome was a composite measure of the levels of the knowledge, attitudes and practice of PFME. Knowledge, attitude and practice of PFME were measured using the Knowledge Attitude Practice (KAP) questionnaire which was adapted and modified with the permission of the author (Rosediani et al., 2012).
Timepoint [1] 321545 0
The knowledge, attitude and practice were assessed at baseline, post-intervention at early third trimester (28-30 gestation weeks), late third-trimester (36-38 gestation weeks) and early postnatal (4-6 weeks after childbirth)
Primary outcome [2] 322024 0
Another primary outcome was self-efficacy in practicing PFME. The Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE) was used to detect the changes in self-efficacy (Sacomori et al., 2013)
Timepoint [2] 322024 0
The self-efficacy of PFME was assessed at baseline, post-intervention at early third trimester (28-30 gestation weeks), late third-trimester (36-38 gestation weeks) and early postnatal (4-6 weeks after childbirth)
Secondary outcome [1] 375329 0
Continence status was measured via self-reporting by using a validated questionnaire based on the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) (Lim et al., 2017)
Timepoint [1] 375329 0
Continence status was measured at baseline, post-intervention at the early third- trimester (28-30 gestation weeks), late third-trimester (36-38 gestation weeks) and early postnatal (4-6 weeks after childbirth)
Secondary outcome [2] 377047 0
The severity of urinary incontinence was scored based on the first three questions in the ICIQ-UI-SF with an overall score between 0 and 21 awarded with the greater values of the overall scores indicated increased severity of UI (Klovning et al., 2009).
Timepoint [2] 377047 0
Severity of urinary symptom was measured at baseline, post-intervention at the early third- trimester (28-30 gestation weeks), late third-trimester (36-38 gestation weeks) and early postnatal (4-6 weeks after childbirth)

Eligibility
Key inclusion criteria
The inclusion criteria of this study were pregnant women at 18 weeks gestation, with a singleton pregnancy and had provided informed consent to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria included pregnant women aged less than 18 years old and non-Malaysian. Also, pregnant women undergoing physiotherapy treatment for severe urinary incontinence had previous urogenital surgery and had chronic medical disorders before pregnancy (uncontrolled diabetes, hypertension, HIV positive, neurological condition or pelvic organ prolapse) were excluded from the study. Other exclusion criteria included pregnant women with a complicated pregnancy or contraindications to the practice of physical activity (preeclampsia, persistent bleeding, pre-term labour, incompetent cervix, acute febrile infection, fetal growth restriction, placenta previa or cephalopelvic disproportion).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using sealed opaque envelopes which contained cards either the alphabet letter “A” for the intervention group or “B” for the control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
the data was analysed by using the Statistical Package for Social Sciences (SPSS) software, version 22.0.
(1) Variations in baseline respondent characteristics between the intervention and control groups were analysed using t-tests for continuous variables, the Mann-Whitney test for skewed continuous variables, and Chi-square tests or Fisher tests for small cell counts for categorical variables.

(2) The differences between the groups at each of the time points; baseline, early third-trimester, late third trimester and early postnatal were assessed using the Mann-Whitney test for the continuous outcome and the Chi-square test for the categorical outcome. While the within-group differences at each of the time points with baseline were assessed using a Wilcoxon Sign Rank Test for continuous outcomes and McNemar’s test for the categorical outcome.
(3) the effects of the interventions on the primary and secondary outcome variables were analysed with a generalised estimation equation (GEE).

The minimum sample size for the study was calculated using a sample size formula for comparing two proportions by Rosner (2006). Since there was no prevailing information on the primary outcome of the intended study, the sample size was calculated based on the occurrence of UI found in a previous study among pregnant women. The prevalence of UI found among pregnant women who attended the Patient Assessment Centre of a tertiary referral hospital in Klang Valley (Malaysia) during the patients’ third trimester was 34.3% (Abdullah et al., 2016). Also, founded on a systematic review by Boyle (2012), women who were randomised to antenatal PFME for mixed prevention and treatment had about 20% less risk of UI in late pregnancy. To allow a 20% attrition rate, the minimum required sample size was 85 participants [units] per group with a total sample size of 170 for both the intervention and control groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/05/2017
Date of last participant enrolment
Anticipated
Actual
29/03/2018
Date of last data collection
Anticipated
Actual
19/07/2018
Sample size
Target
170
Accrual to date
Final
170
Recruitment outside Australia
Country [1] 21890 0
Malaysia
State/province [1] 21890 0
Federal Territory Kuala Lumpur

Funding & Sponsors
Funding source category [1] 303901 0
University
Name [1] 303901 0
University
Country [1] 303901 0
Malaysia
Primary sponsor type
University
Name
University
Address
Universiti Putra Malaysia,
43400, Serdang
Selangor Darul Ehsan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 304049 0
None
Name [1] 304049 0
Address [1] 304049 0
Country [1] 304049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304407 0
Malaysia Ministry of Health Medical Review Ethics Committee (MREC)
Ethics committee address [1] 304407 0
Ethics committee country [1] 304407 0
Malaysia
Date submitted for ethics approval [1] 304407 0
09/01/2017
Approval date [1] 304407 0
20/01/2017
Ethics approval number [1] 304407 0
NMRR-16-2029-28782
Ethics committee name [2] 304445 0
Universiti Putra Malaysia Ethics Committee for human research
Ethics committee address [2] 304445 0
Ethics committee country [2] 304445 0
Malaysia
Date submitted for ethics approval [2] 304445 0
31/03/2017
Approval date [2] 304445 0
04/04/2017
Ethics approval number [2] 304445 0
FPSK(MREC17) P015

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

Contacts
Principal investigator
Name 96842 0
Miss Parwathi Alagirisamy
Address 96842 0
Universiti Putra Malaysia, Jalan UPM, 43400 Serdang, Selangor.
Country 96842 0
Malaysia
Phone 96842 0
+0060163585968
Fax 96842 0
Email 96842 0
[email protected]
Contact person for public queries
Name 96843 0
Dr Sherina Mohd Sidik
Address 96843 0
Cancer Resource &Education Center,
Universiti Putra Malaysia
Jalan UPM, 43400 Serdang, Selangor.
Malaysia
Country 96843 0
Malaysia
Phone 96843 0
+0060389471011
Fax 96843 0
+0060389472706
Email 96843 0
[email protected]
Contact person for scientific queries
Name 96844 0
Dr Sherina Mohd Sidik
Address 96844 0
Cancer Resource &Education Center,
Universiti Putra Malaysia
Jalan UPM, 43400 Serdang, Selangor.
Malaysia
Country 96844 0
Malaysia
Phone 96844 0
+0060389471011
Fax 96844 0
+0060389472706
Email 96844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5135Study protocol    378446-(Uploaded-29-09-2019-14-59-20)-Study-related document.docx



Results publications and other study-related documents

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