Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration

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; Injury, Maternal

Intervention / Treatment
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* Other: perineal massage program
* Other: Pelvic floor muscle exercise program
* Other: Educational pelvic floor dysfunction prevention 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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No

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: 3 programs group<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 duo date | Other: perineal massage program<br>* The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day<br>Other: Pelvic floor muscle exercise program<br>* The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day<br>Other: Educational pelvic floor dysfunction prevention program<br>* This educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation<br>|
| Active Comparator: one program group<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 duo date. | Other: Educational pelvic floor dysfunction prevention program<br>* This educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who need episiotomy at time of delivery | Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator | 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 | At 15 minutes from delivery |