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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03349736
Date of registration: 05/11/2017
Prospective Registration: No
Primary sponsor: Kathmandu University School of Medical Sciences
Public title: Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study PFMT
Scientific title: Pelvic Floor Muscle Training Programme in Pregnant Nepalese Women- a Feasibility Study
Date of first enrolment: June 25, 2017
Target sample size: 253
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03349736
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Nepal
Contacts
Name:     Rajendra Koju, MD
Address: 
Telephone:
Email:
Affiliation:  Kathmandu University School of Medical Sciences
Name:     Britt Stuge, PhD
Address: 
Telephone:
Email:
Affiliation:  Oslo University Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- pregnant women able to understand information and instructions in the Nepalese
language

Exclusion Criteria:

- women with psychiatric diagnosis

- pregnancy related complications like pre-eclampsia

- risk of threatened abortion

- more than 16 weeks duration in 1st visit and

- not willing to participate or not able to communicate



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Pelvic Organ Prolapse
Urinary Incontinence
Intervention(s)
Other: Pelvic Floor Muscle Training
Primary Outcome(s)
To develop a PFMT programme and and second to assess the feasibility in terms of recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability of the PFMT programme in pregnant Nepalese women. [Time Frame: 21 weeks]
Secondary Outcome(s)
Secondary ID(s)
112/2016
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Oslo
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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