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

Delivery; Injury, Maternal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108170
• Other study ID #: 3644
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: December 25, 2018

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 25, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery; Injury, Maternal

Intervention

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
• Pelvic floor muscle exercise program
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
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

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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