Back to resultsPerineal Preparation for Pregnant Ladies.
Primary Purpose
Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3 program
one program
Sponsored by
About this trial
This is an interventional prevention trial for Delivery; Trauma focused on measuring perineal massage, health education, perineal tear, episiotomy, pelvic floor muscle exercise
Eligibility Criteria
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
Sites / Locations
- KasralainiH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
three program
one program
Arm Description
200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.
200 patients are subjected to educational Pelvic floor dysfunction prevention program
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Duration of the second stage of labour
Duration of the second stage of labour will be assessed by an investigator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03287258
Brief Title
Perineal Preparation for Pregnant Ladies.
Official Title
Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness
Keywords
perineal massage, health education, perineal tear, episiotomy, pelvic floor muscle exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
three program
Arm Type
Active Comparator
Arm Description
200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.
Arm Title
one program
Arm Type
Active Comparator
Arm Description
200 patients are subjected to educational Pelvic floor dysfunction prevention program
Intervention Type
Other
Intervention Name(s)
3 program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
one program
Intervention Description
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.
Primary Outcome Measure Information:
Title
perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
Description
Proportion of participants who have perineal tears
Time Frame
At 15 minutes from delivery
Secondary Outcome Measure Information:
Title
episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
Description
Proportion of participants who need episiotomy at time of delivery
Time Frame
At 15 minutes from delivery
Title
Duration of the second stage of labour
Description
Duration of the second stage of labour will be assessed by an investigator
Time Frame
2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Dieb, MD
Organizational Affiliation
KasrAlainiH
Official's Role
Principal Investigator
Facility Information:
Facility Name
KasralainiH
City
Cairo
ZIP/Postal Code
11956
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Perineal Preparation for Pregnant Ladies.
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