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

Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Delivery; Injury, Maternal
• Intervention / Treatment: Other: perineal massage program; Other: Pelvic floor muscle exercise program; Other: Educational pelvic floor dysfunction prevention program

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Greater Cairo
    • Cairo, Greater Cairo, Egypt, 11956
      • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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; 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; 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
Active Comparator: 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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Eman Omran, M.D., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 25, 2018

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 3644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No