Evidence map›Paper›PMID 33436465›Full record

ArticleBMJ open2021

KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol.

Sherina Mohd Sidik, Aida Jaffar, Chai Nien Foo, Noor Azimah Muhammad, Rosliza Abdul Manaf, Siti Irma Fadhilah Ismail, Parwathi Alagirisamy, Amalina Farhi Ahmad Fazlah, Zailiza Suli, Felicity Goodyear-Smith

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04762433 (Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04762433 nacompletednot on this map

Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol

TypeinterventionalSponsorUniversiti Putra MalaysiaRan2021 to 2021Enrolled26ConditionsPregnancy Related, Urinary IncontinenceArmsKegel Exercise Pregnancy Training - app
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

Sherina Mohd SidikDepartment of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia sherina@upm.edu.my.ORCID 0000-0001-6754-6145
Aida JaffarDepartment of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.ORCID 0000-0003-2266-9509
Chai Nien FooDepartment of Population Medicine, Universiti Tunku Abdul Rahman, Kajang, Malaysia.ORCID 0000-0003-0362-6394
Noor Azimah MuhammadDepartment of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Rosliza Abdul ManafDepartment of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.
Siti Irma Fadhilah IsmailDepartment of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.
Parwathi AlagirisamyRehabilitation Department, KPJ Damansara Specialist Hospital, Damansara, Malaysia.
Amalina Farhi Ahmad FazlahComputer Science Department, Faculty of Defence Science and Technology, Universiti Pertahanan Nasional Malaysia, Kuala Lumpur, Malaysia.
Zailiza SuliSelangor State Health Department, Hulu Langat District Health Office, Kajang, Malaysia.
Felicity Goodyear-SmithDepartment of General Practice and Primary Health Care, University of Auckland, Auckland, New Zealand.ORCID 0000-0002-6657-9401
Universiti Putra Malaysia · MYNational Defence University of Malaysia · MYNational University of Malaysia · MYUniversiti Tunku Abdul Rahman · MYUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPelvic 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.

Indexed as

Mobile ApplicationsPelvic FloorAdolescentExercise TherapyFemaleHumansMalaysiaMulticenter Studies as TopicPragmatic Clinical Trials as TopicPregnancyPregnant PeopleQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodTreatment Outcomehealth informaticsmaternal medicineprimary careurinary incontinencesurogynaecology

Identifiers

PMID33436465
PMCPMC7805359
OpenAlexW3119077486

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.