Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China
NCT ID: NCT05242809
Last Updated: 2023-06-27
Study Results
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Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2022-08-21
2023-02-07
Brief Summary
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Detailed Description
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PFMT has been recommended as the first-line treatment for stress urinary incontinence and the other types of urinary incontinence (UI), however, it was not well implemented in many countries due the lack of human resource and financial support. Compared to individual PFMT supervision, which is commonly conducted in hospital with additional fees, delivering PFMT in groups can help more women. Therefore, this study is to codesign and investigate the feasibility of group-based PFMT programme.
The first phase is to co-design the group-based PFMT programme: The stakeholders will be involved in this phase. The stakeholder development group will purposively sample both health professionals and pregnant women with or without UI. The stakeholder development group members will include the principal researcher, two pregnant women without UI, two pregnant women with a history of UI, two midwives (one of the midwives will help the principal researcher to deliver the training session), two physiotherapists. Data from group meetings will be digitally audio-recorded following consent and notes will be taken during the meeting. The data will be analyzed to identify the content and mode of delivery of the group-based PFMT programme along with potential barriers and facilitators.
The second phase is implementation and evaluation of the group-based PFMT programme (randomised controlled feasibility study): Participants will be randomized into two groups, intervention and control group. The control group gets standard care at the hospital. The interventional group gets supervised group-based PFMT. The intervention will be teaching the participants to do PFMT in groups. The intervention will help women to identify their pelvic floor muscles and then guide them how to contract the pelvic floor muscle correctly (the detail of the intervention will be discussed and determined in phase 1 of this project). The core outcome measures are likely to include self-reported UI, which is commonly used in studies and is able to evaluate the effectiveness of PFMT intervention in pregnant women, and UI severity which may be assessed by ICIQ-SF (a validated questionnaire which both assesses the severity of urinary loss and quality of life impact). The adherence to the programme may be assessed by attendance records from the group-based training sessions and completion of a training diary which includes the frequency and duration the participants self-report doing the exercises. The training diary will be submitted to the principal researcher after the training sessions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control group
The control group receives standard care, which means the participants will receive verbal instruction on PFMT from midwives without any further supervision. For reasons of equipoise, women in the comparator group will be offered the group-based PFMT intervention at the end of the study if they wish.
No interventions assigned to this group
Group-based PFMT group
The participants in the intervention group will receive PFMT supervision in groups. The number of women per group and the detail of the intervention will be decided through stakeholder development group meetings.The intervention will be teaching the participants to do PFMT in groups. The intervention will help women to identify their pelvic floor muscles and then guide them how to contract the pelvic floor muscle correctly (the detail of the intervention will be discussed and determined in phase 1 of this project).
Group-based PFMT group
The intervention group receives PFMT supervision in groups of about 6-8 women
Interventions
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Group-based PFMT group
The intervention group receives PFMT supervision in groups of about 6-8 women
Eligibility Criteria
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Inclusion Criteria
2. Gestational ages of 19-24 weeks;
3. With or without the symptom of UI;
4. Singleton fetus
5. Capable of giving valid informed consent
Exclusion Criteria
2. Women with previous UI symptoms before pregnancy
3. High risk of preterm labour
4. Women with previous urogenital surgery or diseases which may interfere with pelvic floor muscle strength, for example, pelvic organ prolapse, neurological disorders, diabetes.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Nanjing Maternity and Child Health Care Hospital
OTHER
King's College London
OTHER
Responsible Party
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Locations
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Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Countries
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References
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Yang X, Zhang A, Sayer L, Bassett S, Woodward S. Co-design of a group-based programme to facilitate adherence to pelvic floor muscle training in pregnant women in China: Describing the process of developing an intervention underpinned by the behaviour change wheel. Midwifery. 2025 May;144:104316. doi: 10.1016/j.midw.2025.104316. Epub 2025 Feb 10.
Yang X, Sayer L, Bassett S, Woodward S. Group-based pelvic floor muscle training for pregnant women: A randomized controlled feasibility study. J Adv Nurs. 2025 Apr;81(4):2099-2112. doi: 10.1111/jan.16365. Epub 2024 Aug 14.
Yang X, Zhang A, Zhu R, Sayer L, Bassett S, Woodward S. Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study. Pilot Feasibility Stud. 2023 Oct 31;9(1):180. doi: 10.1186/s40814-023-01410-2.
Other Identifiers
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20220107
Identifier Type: -
Identifier Source: org_study_id
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