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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108170
Enrollment
90
Registered
2017-04-11
Start date
2017-04-12
Completion date
2018-12-25
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery; Injury, Maternal

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.

Interventions

OTHERperineal 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

The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day

OTHEREducational 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants who have perineal tearsAt 15 minutes from deliveryProportion of perineal tears will be assessed by an investigator who will attend the participant delivery

Secondary

MeasureTime frameDescription
Proportion of participants who need episiotomy at time of deliveryAt 15 minutes from deliveryProportion of participants who need episiotomy at time of delivery will be assessed by an investigator
Duration of the second stage of labourAt 15 minutes from deliveryDuration of the second stage of labour will be assessed by an investigator

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026