Perineal Preparation for Pregnant Ladies.

Pelvic Floor Muscle Weakness 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: NCT03287258
• Other study ID #: perineal preparation study
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2018
• Source: Kasr El Aini Hospital
• 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: 400
• Est. completion date: December 31, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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; Trauma
• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness
• Pelvic Floor; Perineal Rupture, Obstetric
• Rupture

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	KasralainiH	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of the second stage of labour	Duration of the second stage of labour will be assessed by an investigator	2 hours