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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03108170 |
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Date of registration:
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05/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration
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Scientific title:
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Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial |
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Date of first enrolment:
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April 12, 2017 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03108170 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Eman Omran, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant women = 35 years old
- Primigravida or multi gravida
Exclusion Criteria:
- History of chronic constipation
- History of chronic cough
- Current or past urinary or anal incontinence
- History of genital prolapse before pregnancy
- History of neuromuscular disorders or connective tissue disorders
- History of medical disorders
- History of preterm or precipitate labour
- History of premature preterm rupture of membranes.
- Genital infections
Age minimum:
35 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Delivery; Injury, Maternal
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Intervention(s)
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Other: Educational pelvic floor dysfunction prevention program
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Other: perineal massage program
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Other: Pelvic floor muscle exercise program
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Primary Outcome(s)
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Proportion of participants who have perineal tears
[Time Frame: At 15 minutes from delivery]
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Secondary Outcome(s)
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Duration of the second stage of labour
[Time Frame: At 15 minutes from delivery]
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Proportion of participants who need episiotomy at time of delivery
[Time Frame: At 15 minutes from delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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