Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women

Completed

• Conditions: Pregnancy, Childbirth and Puerperal Disorders
• Interventions: Radiation: transperineal pelvic floor ultrasound

• Registration Number: NCT02245386
• Lead Sponsor: Al-Azhar University

Brief Summary

To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and to study the effect of mode of delivery on female sexual function.

Detailed Description

1. 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.

2. answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Status Verified: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.

Exclusion Criteria

1. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3	transperineal pelvic floor ultrasound	(40 women after elective cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.
Group 2	transperineal pelvic floor ultrasound	(40 women after urgent cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.
Group 1	transperineal pelvic floor ultrasound	(40 women after normal vaginal delivery) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.

Primary Outcome Measures

Name	Time	Method
Sexual function of pelvic floor as assessed by the validated female sexual function index	at 3 months after delivery
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound	early postpartum period (48 to 72) hours postpartum

Secondary Outcome Measures

Name	Time	Method
Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound	6 months after delivery.
Sexual function as assessed by the validated female sexual function index	3 months after delivery