NCT03108170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2018

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

April 5, 2017

Last Update Submit

July 13, 2020

Conditions

Delivery; Injury, Maternal

Outcome Measures

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

    At 15 minutes from delivery

Secondary Outcomes (2)

  • 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

Study Arms (2)

3 programs group

ACTIVE COMPARATOR

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 programOther: Pelvic floor muscle exercise programOther: Educational pelvic floor dysfunction prevention program

one program group

ACTIVE COMPARATOR

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

perineal massage programOTHER

The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day

3 programs group
Pelvic floor muscle exercise programOTHER

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

3 programs group
Educational pelvic floor dysfunction prevention programOTHER

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

3 programs groupone program group

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Eman Omran, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

April 12, 2017

Primary Completion

December 20, 2018

Study Completion

December 25, 2018

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Locations

EG(1)