Perineal Preparation for Pregnant Ladies.

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03287258
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 48.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delivery; Trauma; Pelvic Floor; Perineal Rupture, Obstetric; Pelvic Floor Muscle Weakness	Other: 3 program; Other: one program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: Apr 25, 2017
• Actual Primary Completion Date: Jul 20, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
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; 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
Active Comparator: one program 200 patients are subjected to educational Pelvic floor dysfunction prevention program	Other: one 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.

Outcome Measures

Primary Outcome Measures

1. perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery [At 15 minutes from delivery]

   Proportion of participants who have perineal tears

Secondary Outcome Measures

1. episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator [At 15 minutes from delivery]

   Proportion of participants who need episiotomy at time of delivery

2. Duration of the second stage of labour [2 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KasralainiH	Cairo		Egypt	11956

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

• Principal Investigator: Amira Dieb, MD, KasrAlainiH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amira S Dieb, Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT03287258
• Other Study ID Numbers: perineal preparation study
• First Posted: Sep 19, 2017
• Last Update Posted: Nov 2, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amira S Dieb, Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital, Kasr El Aini Hospital: perineal massage; health education; perineal tear; episiotomy; pelvic floor muscle exercise
• Additional relevant MeSH terms: Muscle Weakness; Rupture

Study Results

No Results Posted as of Nov 2, 2018