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CompletedNCT03287258Updated Nov 2, 2018

Perineal Preparation for Pregnant Ladies.

An interventional study of 3 program and one program in Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric and Pelvic Floor Muscle Weakness, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
400
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; Trauma
  • Pelvic Floor; Perineal Rupture, Obstetric
  • Pelvic Floor Muscle Weakness

Keywords

  • perineal massage
  • health education
  • perineal tear
  • episiotomy
  • pelvic floor muscle exercise
03

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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
04

Study design

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

Study arms

  • Active comparator
    three program

    200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.

    Other: 3 program

  • Active comparator
    one program

    200 patients are subjected to educational Pelvic floor dysfunction prevention program

    Other: one program

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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: At 15 minutes from delivery

Secondary outcomes

  1. 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

    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: 2 hours

06

Study locations

1 site
  • KasralainiH
    Cairo, 11956, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03287258
Lead sponsor
Kasr El Aini Hospital
Responsible party
Amira S Dieb (Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Kasr El Aini Hospital) — Principal investigator
First posted
Sep 19, 2017
Start date
Apr 25, 2017
Primary completion
Jul 20, 2017
Completion
Dec 31, 2017
Last update
Nov 2, 2018

Study contacts

Amira Dieb, MD
principal investigator · KasrAlainiH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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