Perineal Preparation for Pregnant Ladies.

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: Pelvic Floor Muscle Weakness; Delivery; Trauma; Pelvic Floor; Perineal Rupture, Obstetric
• Intervention / Treatment: Other: 3 program; Other: one 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): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11956
    • KasralainiH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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: three program; 200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.	Other: 3 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 due date
Active Comparator: one program; 200 patients are subjected to educational Pelvic floor dysfunction prevention program	Other: one 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 due date.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator	Proportion of participants who need episiotomy at time of delivery	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	2 hours

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Amira Dieb, MD, KasralainiH

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 22, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: health education; perineal tear; episiotomy; pelvic floor muscle exercise; perineal massage
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Rupture
• Other Study ID Numbers: perineal preparation study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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