Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women

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

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

Study Overview

• Status: Unknown
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Diagnostic test: female sexual function index

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women who delivered vaginally or Cesarean for the first time within 6 months to 5 years before evaluation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vaginal delivery; Women underwent non complicated non instumental normal vaginal delivery	Diagnostic test: female sexual function index; evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions
Cesarean section; Women underwent elective Cesarean section	Diagnostic test: female sexual function index; evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary incontinence	evaluation using the International Consultation on Incontinence Questionnaire Short Form	6 months after delivery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No