Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001030369
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
17/07/2017
Date last updated
5/02/2020
Date data sharing statement initially provided
14/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of antenatal pelvic floor muscle exercises on female sexual function: A randomised controlled trial
Scientific title
For primiparous women, do the antenatal pelvic floor muscle exercises improve female sexual function during pregnancy and the first three months following birth when compared with standard antenatal care alone? A randomised controlled trial
Secondary ID [1] 292132 0
Nil Known
Universal Trial Number (UTN)
U1111-1197-6617
Trial acronym
Pelvic floor muscle exercise (PFME)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Sexual Function 303562 0
Condition category
Condition code
Public Health 302974 302974 0 0
Health promotion/education
Reproductive Health and Childbirth 302975 302975 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 302976 302976 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, the intervention will consist of training on how to perform pelvic floor muscle exercise. The researcher (PhD Candidate) will be teaching women on how to perform pelvic floor muscle exercises.{The researcher is a registered midwife, has been providing care and education to women across midiwfery practice from antenatal care, labour and birth and postnatal care. She is currently a PhD candidate of midiwfery. She also has a research background on pelvic organ prolapse, urinary incontinece and their association with pelvic floor muscle strength. To design the intervention in this study, arrangment with physiotherapy department has been done to stay consistent with current practice and also to receive supplementary materials such as pamphelet 06 on the benefit of pelvic floor exercise published by Australian Continence association, as stated in next section). To develop intervention in this trial the following published resources were used including; ( “(The knack”) (Miller, Ashton-Miller, & DeLancey, 1998) and the study carried out by Elbegway et al (Elbegway et al., 2010) Morkved.“(The knack) (Miller, Ashton-Miller, & DeLancey, 1998; Miller, Sampselle, Ashton-Miller, Hong, & DeLancey, 2008), the studies carried out by Elbegway et al (Elbegway et al., 2010), Morkved et al ((Mørkved et al., 2003)), Morkved et al (Mørkved & Bø, 2014) and Alves et al (Alves, de Carvalho Cavalli, Bertacini, & Driusso, 2016)

The initial session will be individual face to face training and is estimated to take 30 minutes. Women will be instructed as follows:
1. Squeeze the anal sphincter, the vaginal and urethral as tightly as possible.
2. To increase the intensity of their effort.
3. To hold the contraction as tightly as they can for 8-10 seconds.
4. To relax their effort, allowing their muscle to relax and rest for 8-10 seconds.
5. To repeat the sequence 8 times
6. To perform five fast pelvic floor muscle contractions after completing slow contractions.
7. To perform one set of 13 PFME (eight slow and five fast) three times a day.
8. 7. To do this daily.
Women will be instructed to coordinate breathing with pelvic floor muscle contractions.
The women will be explained to lift up and inward around urethra, vagina, rectum, and squeeze as hard as they can and hold it for 8-10 seconds before relaxing the muscles gently. Women will be asked to keep breathing in and out during the contractions (Mørkved & Bø, 2014). Women will be instructed to perform PFME in different positions so they can choose the most comfortable position to practice PFME at home. Women will be also instructed of the knack method.
Women in the intervention group will also be provided a compliance diary to record their exercises daily. Red stick up spots will be given to use as triggers on shower, teeth, meals, queues etc) will be used to remind women to do the exercises as this has been demonstrated to be effective (Miller et al., 1998).
Women will be instructed to perform pelvic floor muscle exercises in different positions and also to grip up before cough, sneeze, lift, bend. They will be encouraged to continue these exercise in the postpartum as above and also incorporating good bladder habits. Women will receive telephone follow up fortnightly. Follow up will stop after birth. There will not be any fortnightly follow up in the postpartum period. Intervention will cease when women in intervention group give birth. Women in both control and intervention groups will be contacted once at three months after birth to collect data.
The duration of intervention is from 20 weeks of pregnancy until birth. The study setting is antenatal clinic of Westmead Public Hospital, Low risk primiparous pregnant women will be recruited at antenatal clinics at less than 22 weeks gestation and will be randomised to control and training group. Training group will receive routine antenatal care as well as an individual face to face instruction on how to perform pelvic floor muscle exercise as stated above and will receive fortnightly follow up via text messages. Women will be provided diary to record their compliance. Women in intervention group will be provided additional pamphlets to read. The pamphlet is the vision 06 titled "Pelvic floor muscle training for women" published by continence foundation of Australia and is available at Westmead hospital.
Intervention code [1] 298283 0
Prevention
Intervention code [2] 298284 0
Treatment: Other
Comparator / control treatment
The control group will receive routine standard antenatal care and education during pregnancy. The routine antenatal care is provided by midwives and information about pelvic floor muscle exercise is given to woman along with the other educations and care in pregnancy in only one antenatal visit which takes normally less than 20 minutes. There are also extra antenatal classes run by midwives at hospital and they carry a fee for participants. These antenatal classes are not focused on pelvic floor muscle exercise as an ongoing practice with adequate follow up during pregnancy. in this study, women in control group will not receive the intervention and follow up as stated above from researcher. However, they are not discouraged to perform pelvic floor muscle exercise on their own during pregnancy and the postpartum period.
Control group
Active

Outcomes
Primary outcome [1] 302359 0
Female sexual function during pregnancy and three months following birth will be measured using female sexual function index self -report questionnaire
Timepoint [1] 302359 0
Information about Female sexual function will be collected at the time of booking at less than 22 weeks gestation, at 36 weeks of pregnancy and at three months following birth from both intervention and control groups
Secondary outcome [1] 335728 0
Childbirth outcomes (including; duration of three stages of labour, fetal positions and presentation at birth, mode of birth (normal vaginal birth, caesarean section and instrumental birth), episiotomy and perineal trauma rate (1st, 2nd, 3rd and 4th degree).
as well as fetal outcomes such as APGAR score, head circumference, length, weight). (a composite secondary outcome).
Timepoint [1] 335728 0
information about Childbirth outcomes will be collected after birth from both control and intervention groups via Obstetrix database system at Westmead Public Hospital
Secondary outcome [2] 335729 0
Urinary incontinence symptoms (a composite outcome)
Timepoint [2] 335729 0
Data regarding Urinary incontinence symptoms will be collected at the time of booking, at 36 weeks pregnancy and three months following birth from both control and intervention groups using UDI-6 questionnaire
Secondary outcome [3] 335730 0
Specific quality of life
Timepoint [3] 335730 0
Specific quality of life will be measured at the time of booking, at 36 weeks pregnancy and at three months following birth from both control and intervention groups using a IIQ-7 questionnaire
Secondary outcome [4] 336389 0
Faecal incontinence symptoms
Timepoint [4] 336389 0
Data about faecal incontinence symptoms will be collected at the time of booking, at 36 weeks of pregnancy and at three months following birth from both control and training groups via a faecal incontinence questionnaire

The faecal incontinence questionaire being used in this study is the short form of Waxner et al questionnaire which has been validated in Australia. (Sansoni, J.A., Marosszeky, M., Sansoni, E, & Hawthrone, G. (2006). Designing a faecal incontinence instrument using survey data, National Health Outcomes Conference. Australian Health Outcomes Collaboration, Wollongong, Australia, 1-8.)

Eligibility
Key inclusion criteria
Primiparous women over 18 years old and equal or less than 22 weeks gestation
• Having a current sexual partner
• Singleton pregnancy
• Anticipating a vaginal birth
• With no history of urinary incontinence or pelvic surgery or pelvic organ prolapse
• Able to read and understand and communicate in English
• No previous history of depression, mental illness, alcohol and drug use, domestic violence
The women in intervention group should also agree to follow the pelvic floor exercise programme in this study and not to follow the other programmes being offered to them via other resources.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Over 22 weeks gestation
• Planning to give birth via caesarean section at the time of booking
• Multiparous women
• Women with multiple pregnancy,
• Women with complicated pregnancies (type 1 and type 2 diabetic, vaginal bleeding) and those with known pelvic floor muscle dysfunction)
• Women who are not able to read and understand English to answer the questionnaires

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer-generated randomiser will be used to generate the randomisation sequence and randomisation will be remote to WPH
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will occur from the online randomisation service
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The researcher and particiapnts are not blineded to group allocations. The other care providers in the antenatal clinics are blinded to the group allocations. The researcher will be kept blinded to the group allocation at the time of statistical analysis. The data entry will be electronically so the researcher will stay blind. Hardcopies quetionnaires will be coded and de-idenitified data will be entered into electronic system to store data. So, the researcher will be blinded during data entry to the partciapnts answers. A centralised remote computer randomisation will be used for randomisation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of the primary and secondary outcome will be based on intention-to-treat basis which will include withdrawal and losses to follow up. Odds ratios, percentage differences, confidence intervals, Chi-square and student’s t tests will be used to examine group differences in the primary and secondary outcomes. Data from REDCAP will be exported and SPSS will be used to analyse data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2017
Actual
11/02/2018
Date of last participant enrolment
Anticipated
31/07/2018
Actual
20/09/2018
Date of last data collection
Anticipated
31/03/2019
Actual
2/06/2019
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8306 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 16369 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 296670 0
University
Name [1] 296670 0
Western Sydney university
Country [1] 296670 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 295636 0
None
Name [1] 295636 0
Address [1] 295636 0
Country [1] 295636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297895 0
Western Sydney Health District
Ethics committee address [1] 297895 0
Ethics committee country [1] 297895 0
Australia
Date submitted for ethics approval [1] 297895 0
14/06/2017
Approval date [1] 297895 0
05/12/2017
Ethics approval number [1] 297895 0
HREC/17/WMEAD/276
Ethics committee name [2] 297903 0
Western Sydney University
Ethics committee address [2] 297903 0
Ethics committee country [2] 297903 0
Australia
Date submitted for ethics approval [2] 297903 0
22/01/2018
Approval date [2] 297903 0
25/01/2018
Ethics approval number [2] 297903 0
RH12581
Ethics committee name [3] 297904 0
Westemad Hospital
Ethics committee address [3] 297904 0
Ethics committee country [3] 297904 0
Australia
Date submitted for ethics approval [3] 297904 0
07/12/2017
Approval date [3] 297904 0
19/01/2018
Ethics approval number [3] 297904 0
SSA/17/WMEAD/62

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1807 1807 0 0
/AnzctrAttachments/373084-Study protocol version 1.docx (Protocol)
Attachments [2] 1808 1808 0 0
/AnzctrAttachments/373084-participant information sheet VERSION 1.docx (Participant information/consent)
Attachments [3] 1809 1809 0 0
/AnzctrAttachments/373084-participant consent form VERSION 1.docx (Participant information/consent)
Attachments [4] 2798 2798 0 0
/AnzctrAttachments/373084-PICF version5clean.docx (Participant information/consent)
Attachments [5] 2799 2799 0 0
/AnzctrAttachments/373084-Studyprotocolversion2.docx (Protocol)

Contacts
Principal investigator
Name 75394 0
Miss Sahar Sobhgol
Address 75394 0
School of Nursing and Midwifery
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country 75394 0
Australia
Phone 75394 0
+61 452503035
Fax 75394 0
+61 2 9685 9959
Email 75394 0
[email protected]
Contact person for public queries
Name 75395 0
Caroline Smith
Address 75395 0
School of Nursing and Midwifery
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country 75395 0
Australia
Phone 75395 0
+61 452503035
Fax 75395 0
+61 2 9685 9959
Email 75395 0
[email protected]
Contact person for scientific queries
Name 75396 0
Sahar Sobhgol
Address 75396 0
School of Nursing and Midwifery Western Sydney University Locked Bag 1797 Penrith NSW 2751 Australia
Country 75396 0
Australia
Phone 75396 0
+61 452503035
Fax 75396 0
+61 2 9685 9959
Email 75396 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
Individual participant data is considered confidential. Only the result of the study will be published in journals and seminars


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: Study protocol for a pragmatic randomised controlled trial.2019https://dx.doi.org/10.1186/s13063-019-3226-6
EmbaseThe effect of antenatal pelvic floor muscle exercise on sexual function and labour and birth outcomes: A randomised controlled trial.2022https://dx.doi.org/10.1016/j.wombi.2022.02.009
N.B. These documents automatically identified may not have been verified by the study sponsor.