Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000608763
Ethics application status
Approved
Date submitted
16/03/2022
Date registered
22/04/2022
Date last updated
4/09/2023
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic floor muscle contraction during routine pregnancy ultrasound
Scientific title
Is Ultrasound in Pregnancy an opportunity for Prevention of Pelvic floor dysfunction? A feasibility study
Secondary ID [1] 305683 0
None
Universal Trial Number (UTN)
Trial acronym
UPPP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor dysfunction 324163 0
Condition category
Condition code
Renal and Urogenital 321635 321635 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 321636 321636 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 323376 323376 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is using transabdominal ultrasound scan to visualise maternal pelvic floor muscle contraction as a form of biofeedback during routine fetal anatomy scan, which also uses transabdominal ultrasound. Both components of the scan (fetal anatomy and pelvic floor muscle contraction) will be conducted by sonographers. This is in addition to written information on pelvic floor exercise given at the time of recruitment.

The pelvic floor muscle contraction component will involve the participant in supine position with the ultrasound probe placed transversely in the midline in the suprapubic region visualising the bladder base. Women will be asked to observe the ultrasound screen while they perform a pelvic floor muscle contraction. The participant will be oriented to the direction of the bladder base on the screen and the direction of movement of the bladder base. The sonographer instruct a voluntary pelvic floor muscle contraction by saying “relax your thighs, buttocks and tummy muscles. Now, squeeze and lift around your vagina or back passage. Imagine you are trying to hold back urine, or stop passing wind”. These instructions are the same as those on the leaflet provided in the study pack at recruitment. A correct pelvic floor muscle contraction will result in elevation of the bladder base. Each woman will be given up to five attempts to demonstrate a correct pelvic floor muscle contraction during the scan, which will add up to five minutes of scan time. The scan will occur between 18 to 22 weeks gestation of pregnancy. The sonographer at each scan will indicate on the scan report whether the pelvic floor muscle contraction component of the scan has occurred.

The written information will consist of a brief summary of the New Zealand Ministry of Health recommendations for pelvic floor muscle exercise in pregnancy, and written instructions on how to perform a correct pelvic floor muscle contraction, and pelvic floor exercise adapted from the Continence New Zealand Pelvic Floor Training Program and independently reviewed by a pelvic floor physiotherapist. Pelvic floor exercise will not be formally prescribed but the written information will advise participants to aim to holding each contraction for 10 seconds then relax for 10 seconds, doing 10 contractions in a row per set, and 3 sets per day until the muscles feel strong then aim to do a maintenance set of 10 strong holds every day forever.
Intervention code [1] 322078 0
Prevention
Comparator / control treatment
Routine fetal anatomy scan and written information on pelvic floor exercise.

Routine fetal anatomy scan usually occurs between 18-22 weeks of gestation in pregnancy, and the scan duration is around 30 minutes.

The written information on pelvic floor exercise, given at the time of recruitment, is the same for both the intervention and control groups.
Control group
Active

Outcomes
Primary outcome [1] 329396 0
Feasibility of recruitment method including how many women were invited to participate in study, how many women consented, and time taken to recruit 50 women.

This is a composite primary outcome.

How many women were invited to participate is determined by how many information packs were handed out, which will be recorded by those who hand them out.

How many women consented is determined by how many completed their consent form and baseline questionnaire.

Time taken to recruit 50 women, if achieved, will be in number of days from start of recruitment.
Timepoint [1] 329396 0
When 50 participants have entered the study or 31st December 2023, which ever is earlier
Primary outcome [2] 329397 0
Retention of study participants including number of withdrawals, response rates for questionnaires, and amount of incomplete questionnaires.

This is a composite primary outcome.

Number of withdrawals will be recorded in a log by the primary researcher. Each participant will be advised to contact the primary researcher if they want to withdraw from the study. Those who has abnormal fetal anatomy scan findings will be withdrawn, and the scanning sonographer will notify the primary researcher for these participants.

Response rate for questionnaires will be determined by number of each questionnaires (36 week questionnaire and 3 month after delivery questionnaire) that has been either fully or partially completed by participants, over the number that completed the baseline questionnaire and consent as the denominator.

The amount of incomplete questionnaires will be determined by number of each questionnaires (36 week questionnaire and 3 month after delivery questionnaire) that has been partially completed by participants, over the denominator of total number of the same questionnaires that has been both fully and partially completed.
Timepoint [2] 329397 0
When all required questionnaires are collected or 31st December 2024, which ever is earlier
Primary outcome [3] 329398 0
Acceptability of the intervention to the participants is assessed by calculating the proportion of women who answered agree or strongly agree to the question “I believe the additional time of showing me a pelvic floor contraction was worthwhile” from the 36 week gestation questionnaire in the intervention group.
Timepoint [3] 329398 0
At 36 weeks gestation (14 - 18 weeks post intervention)
Secondary outcome [1] 402450 0
Primary outcome - Ability to deliver the intervention as planned. The sonographers will indicate whether the pelvic floor muscle contraction component of the scan is performed for each participant in the intervention, and this is calculated as proportion of women who had their pelvic floor muscle contraction assessed on scan in relation to the total number of women who are in the intervention group.
Timepoint [1] 402450 0
At fetal anatomy scans between 18 - 22 weeks gestation, i.e. the time of intervention
Secondary outcome [2] 402452 0
Primary outcome - average time to assess voluntary pelvic floor muscle contraction on transabdominal ultrasound scan. The sonographers will indicate this in minutes in their report for each participant in the intervention group.
Timepoint [2] 402452 0
At fetal anatomy scans between 18 - 22 weeks gestation, i.e. the time of intervention
Secondary outcome [3] 402453 0
Impact of the intervention on pelvic floor exercise self-efficacy. This is assessed by following study questionnaire questions
-How often did you do Pelvic Floor Muscle Exercises over the last month?
-On the days you did exercises during the last month, on average how many Pelvic Floor Muscle contractions would you do per day?
-How long can you hold a Pelvic Floor Muscle contraction
-I believe I can contract my pelvic floor muscles as intensive as I can
-I believe I can contract my pelvic floor muscles for duration of 5 seconds
-I believe I can contract my pelvic floor muscles for duration of 10 seconds
-I believe I can perceive the contraction of the muscle while I am doing pelvic floor muscle exercises
Timepoint [3] 402453 0
At 36 weeks gestation (14-18 weeks post intervention) and 3 months postpartum (approximately 7 months post intervention)
Secondary outcome [4] 408792 0
Primary outcome - feasibility and acceptability of the intervention to sonographers. This is assessed by an audio recorded face to face interview with the follow questions
-Their perception of how women feel about the scans and any feedback they have received during the scans
-How they themselves feel about the PFMC component of the scan and their own confidence in delivering this part of the scan
-Any difficulties and challenges encountered during the scan
-Any adjustments they can recommend to make the scanning easier.
Timepoint [4] 408792 0
At the end of the study, where each sonographer is interviewed face to face in a semi-structured 15 minute audio-recorded interview with a member of the research team
Secondary outcome [5] 408793 0
Impact of the intervention on urinary symptoms. This is assessed by following study questionnaire questions
-How often do you leak urine?
-How much urine do you usually leak?
-How much does leaking urine interfere with your everyday life? (scale 1-10)
-What leads to urine leakage?
Timepoint [5] 408793 0
At 36 weeks gestation (14-18 weeks post intervention) and 3 months postpartum (approximately 7 months post intervention)
Secondary outcome [6] 408794 0
Impact of the intervention on bowel symptoms. This is assessed by below study questionnaire questions
-Do you leak, have accidents or lose control with solid stool?
-How much do your bowel symptoms interfere with your everyday life?
Timepoint [6] 408794 0
At 36 weeks gestation (14-18 weeks post intervention) and 3 months postpartum (approximately 7 months post intervention)

Eligibility
Key inclusion criteria
Nulliparous women with singleton pregnancy and able to read and complete questionnaires written in English
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are not having their fetal anatomy scan at Horizon Radiology Sylvia Park

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated allocation sequence using permuted blocks of four.
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


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
23/05/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
28
Final
Recruitment outside Australia
Country [1] 24257 0
New Zealand
State/province [1] 24257 0
Auckland

Funding & Sponsors
Funding source category [1] 310045 0
Charities/Societies/Foundations
Name [1] 310045 0
Mercia Barnes Trust
Country [1] 310045 0
New Zealand
Primary sponsor type
Individual
Name
Siyan Ma
Address
Department of obstetrics and gynaecology
Counties Manukau Health
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 312176 0
None
Name [1] 312176 0
Address [1] 312176 0
Country [1] 312176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309741 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309741 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309741 0
New Zealand
Date submitted for ethics approval [1] 309741 0
16/03/2022
Approval date [1] 309741 0
05/04/2022
Ethics approval number [1] 309741 0
2022 EXP 11425

Summary
Brief summary
Pregnancy and childbirth are major risk factors for urinary incontinence in women. Consequently, there is a unique opportunity to implement prevention strategies, particularly pelvic floor muscle exercises (PFME), both antenatally and postnatally, to reduce both the impact of this condition on sufferers and also potentially the need for subsequent surgery.

We are proposing evaluating, for the first time, a unique biofeedback opportunity for a pregnant woman to learn and confirm a correct pelvic floor muscle contraction (PFMC) at the time of a transabdominal ultrasound (TA USS) fetal anatomy scan. A correct PFMC is the basis of effective PFME.

The primary aim of this randomised controlled feasibility study is to assess the feasibility of a randomized controlled trial design, and the intervention, in women presenting for TA USS. If feasible, planning will be undertaken to conduct an appropriate powered trial to investigate the effectiveness of TA USS, used to demonstrate a correct PFMC, to increase uptake and adoption of PFME during pregnancy and reduction in urinary incontinence in late pregnancy and postpartum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115230 0
Dr Siyan Ma
Address 115230 0
Department of obstetrics and gynaecology
Counties Manukau Health
Private Bag 93311
Otahuhu
Auckland 1640
Country 115230 0
New Zealand
Phone 115230 0
+64 210555849
Fax 115230 0
Email 115230 0
siyan.ma@middlemore.co.nz
Contact person for public queries
Name 115231 0
Dr Siyan Ma
Address 115231 0
Department of obstetrics and gynaecology
Counties Manukau Health
Private Bag 93311
Otahuhu
Auckland 1640
Country 115231 0
New Zealand
Phone 115231 0
+64 210555849
Fax 115231 0
Email 115231 0
uppp_trial@otago.ac.nz
Contact person for scientific queries
Name 115232 0
Dr Siyan Ma
Address 115232 0
Department of obstetrics and gynaecology
Counties Manukau Health
Private Bag 93311
Otahuhu
Auckland 1640
Country 115232 0
New Zealand
Phone 115232 0
+64 210555849
Fax 115232 0
Email 115232 0
uppp_trial@otago.ac.nz

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?

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
No additional documents have been identified.