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CompletedNCT03108170Updated Jul 15, 2020

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

An interventional study of perineal massage program and Pelvic floor muscle exercise program in Delivery; Injury, Maternal, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Delivery; Injury, Maternal
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Pregnant women ≥ 35 years old
  • Primigravida or multi gravida

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    3 programs group

    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 duo date

    Other: perineal massage program · Other: Pelvic floor muscle exercise program · Other: Educational pelvic floor dysfunction prevention program

  • Active comparator
    one program group

    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 duo date.

    Other: Educational pelvic floor dysfunction prevention program

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

  • OtherPelvic floor muscle exercise program

    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

06

What researchers measure

Primary outcomes

  1. Proportion of participants who have perineal tears

    Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery

    Time frame: At 15 minutes from delivery

Secondary outcomes

  1. 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

    Time frame: At 15 minutes from delivery

  2. Duration of the second stage of labour

    Duration of the second stage of labour will be assessed by an investigator

    Time frame: At 15 minutes from delivery

07

Study locations

1 site
  • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
    Cairo, Greater Cairo 11956, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03108170
Lead sponsor
Cairo University
Responsible party
Eman Omran (Principal investigator, Cairo University) — Principal investigator
First posted
Apr 11, 2017
Start date
Apr 12, 2017
Primary completion
Dec 20, 2018
Completion
Dec 25, 2018
Last update
Jul 15, 2020

Study contacts

Eman Omran, M.D.
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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