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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2018-12-25

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.

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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.

Conditions

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Delivery; Injury, Maternal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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3 programs group

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

Group Type ACTIVE_COMPARATOR

perineal massage program

Intervention Type OTHER

The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day

Pelvic floor muscle exercise program

Intervention Type OTHER

The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day

Educational pelvic floor dysfunction prevention program

Intervention Type OTHER

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

one program group

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.

Group Type ACTIVE_COMPARATOR

Educational pelvic floor dysfunction prevention program

Intervention Type OTHER

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

Interventions

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perineal massage program

The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day

Intervention Type OTHER

Pelvic floor muscle exercise program

The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day

Intervention Type OTHER

Educational pelvic floor dysfunction prevention program

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

Intervention Type OTHER

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No