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

Not Applicable

Completed

• Conditions: Delivery; Injury, Maternal

• 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.

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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