Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Proportion of participants who have perineal tears
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of participants who have perineal tears
Time Frame: At 15 minutes from delivery
Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
Secondary Outcomes
- Proportion of participants who need episiotomy at time of delivery(At 15 minutes from delivery)
- Duration of the second stage of labour(At 15 minutes from delivery)
Investigators
Eman Omran
Principal investigator
Cairo University