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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03287258
Enrollment
400
Registered
2017-09-19
Start date
2017-04-25
Completion date
2017-12-31
Last updated
2018-11-02

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

Conditions

Delivery; Trauma, Pelvic Floor Muscle Weakness, Pelvic Floor; Perineal Rupture, Obstetric

Keywords

perineal massage, health education, perineal tear, episiotomy, pelvic floor muscle exercise

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

OTHER3 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

OTHERone 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.

Sponsors

Kasr El Aini Hospital
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
Yes

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

Secondary

MeasureTime frameDescription
episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigatorAt 15 minutes from deliveryProportion of participants who need episiotomy at time of delivery
Duration of the second stage of labour2 hoursDuration 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