AI Article Synopsis

  • Pelvic floor muscle training (PFMT) is highly recommended for pregnant women experiencing incontinence, and this study will evaluate the effectiveness of a mobile app for guiding this exercise.
  • A total of 370 pregnant women will be randomly assigned to either receive PFMT through the app or standard care, and their urinary incontinence levels will be assessed at various points during and after the intervention.
  • The study has received ethical approval, includes informed consent from participants, and aims to provide valuable insights into both the effectiveness and cost-effectiveness of using mobile technology in PFMT for pregnant women.

Article Abstract

Introduction: Pelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women.

Methods And Analysis: 370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.

Ethics And Dissemination: This study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.

Trial Registration Number: ACTRN12619000379112.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7805359PMC
http://dx.doi.org/10.1136/bmjopen-2020-039076DOI Listing

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