Back to resultsEffects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
Primary Purpose
Pregnancy, Childbirth and Puerperal Disorders
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
postpartum female pelvic floor muscle affection
postpartum sexual function in Egyptian women.
Sponsored by
About this trial
This is an interventional diagnostic trial for Pregnancy, Childbirth and Puerperal Disorders focused on measuring postpartum pelvic floor
Eligibility Criteria
Inclusion Criteria:
- primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.
Exclusion Criteria:
- Refused consent. 2. Previous vaginal or cesarean delivery. 3. Severe mental illness. 4. Severe physical handicap or difficulties in communication. 5. Women without postpartum active sexual life or separate from their spouse. 6. Past history of sexual dysfunction.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
vaginal delivery
elective cesarean section
urgent cesarean section
Arm Description
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
Outcomes
Primary Outcome Measures
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound had worst morbidity after normal vaginal delivery
Secondary Outcome Measures
Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02338219
Brief Title
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
Official Title
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is t o evaluate levator ani morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) ultrasound, and to study the effect of mode of delivery on female sexual function.
Detailed Description
transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Childbirth and Puerperal Disorders
Keywords
postpartum pelvic floor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaginal delivery
Arm Type
Active Comparator
Arm Description
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
Arm Title
elective cesarean section
Arm Type
Active Comparator
Arm Description
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
Arm Title
urgent cesarean section
Arm Type
Active Comparator
Arm Description
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
Intervention Type
Other
Intervention Name(s)
postpartum female pelvic floor muscle affection
Intervention Description
transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
Intervention Type
Other
Intervention Name(s)
postpartum sexual function in Egyptian women.
Intervention Description
answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound had worst morbidity after normal vaginal delivery
Time Frame
early postpartum period (48 to 72) hours postpartum
Secondary Outcome Measure Information:
Title
Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery
Time Frame
at 3 months after delivery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.
Exclusion Criteria:
Refused consent. 2. Previous vaginal or cesarean delivery. 3. Severe mental illness. 4. Severe physical handicap or difficulties in communication. 5. Women without postpartum active sexual life or separate from their spouse. 6. Past history of sexual dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Edessy, prof
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhamed Osman Osman
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
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