Perineal Preparation for Pregnant Ladies.

Study Overview
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Brief Summary
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Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Detailed Description
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Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Official 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.

Conditions
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Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness

Intervention / Treatment
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* Other: 3 program
* Other: one program


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: three program<br>200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise. | Other: 3 program<br>* The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date<br>|
| Active Comparator: one program<br>200 patients are subjected to educational Pelvic floor dysfunction prevention program | Other: one program<br>* The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery | Proportion of participants who have perineal tears | At 15 minutes from delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator | Proportion of participants who need episiotomy at time of delivery | At 15 minutes from delivery | 
| Duration of the second stage of labour | Duration of the second stage of labour will be assessed by an investigator | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal tear, episiotomy, pelvic floor muscle exercise, perineal massage, health education