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NCT03126604 Clinical Trial

Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women

Pelvic Floor Disorders Clinical Trial

Official title:
Evaluation of Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03126604
Other study ID # 5
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 20, 2017
Last updated April 20, 2017
Start date May 2017
Est. completion date January 2018

Study information
Verified date April 2017
Source Cairo University
Contact Ahmed Maged, MD
Phone 01005227404
Email prof.ahmedmaged@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section

Description:

A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires:

1. Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory

2. Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form

3. Fecal incontinence was evaluated using Wexner Fecal Incontinence Score

4. Sexual functions were evaluated using female sexual function index

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 5000
Est. completion date January 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- primiparity,

- singleton pregnancy

- cephalic presentation

- term delivery (38-42 weeks).

Exclusion Criteria:

- Women with operative vaginal delivery (vacuum extraction or forceps delivery)

- women who had another delivery between the time of first one and time of evaluation

- women with neurological diseases

- women with vascular diseases and Diabetes Mellitus

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• female sexual function index
evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions

Locations
Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary urinary incontinence evaluation using the International Consultation on Incontinence Questionnaire Short Form 6 months after delivery
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