NCT03287258

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

July 22, 2017

Last Update Submit

October 31, 2018

Conditions

Delivery; TraumaPelvic Floor; Perineal Rupture, ObstetricPelvic Floor Muscle Weakness

Keywords

perineal massagehealth educationperineal tearepisiotomypelvic floor muscle exercise

Outcome Measures

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

    At 15 minutes from delivery

Secondary Outcomes (2)

  • episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator

    At 15 minutes from delivery

  • Duration of the second stage of labour

    2 hours

Study Arms (2)

three program

ACTIVE COMPARATOR

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

Other: 3 program

one program

ACTIVE COMPARATOR

200 patients are subjected to educational Pelvic floor dysfunction prevention program

Other: one program

Interventions

3 programOTHER

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

three program
one programOTHER

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.

one program

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersYes
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)

KasralainiH

Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Wounds and InjuriesHealth Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Amira Dieb, MD

    KasrAlainiH

    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
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Study Record Dates

First Submitted

July 22, 2017

First Posted

September 19, 2017

Study Start

April 25, 2017

Primary Completion

July 20, 2017

Study Completion

December 31, 2017

Last Updated

November 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)