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

Not Applicable

Completed

• Conditions: Delivery; Injury, Maternal
• Interventions: Other: perineal massage program; Other: Pelvic floor muscle exercise program; Other: Educational pelvic floor dysfunction prevention program

• Registration Number: NCT03108170
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2017-04-12
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Pregnant women ≥ 35 years old
• Primigravida or multi gravida

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 programs group	Educational pelvic floor dysfunction prevention program	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
3 programs group	Pelvic floor muscle exercise program	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
3 programs group	perineal massage program	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
one program group	Educational pelvic floor dysfunction prevention program	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants who have perineal tears	At 15 minutes from delivery	Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who need episiotomy at time of delivery	At 15 minutes from delivery	Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
Duration of the second stage of labour	At 15 minutes from delivery	Duration of the second stage of labour will be assessed by an investigator

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital; 🇪🇬 Cairo, Greater Cairo, Egypt