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

Phase 1

Completed

• Conditions: Pregnancy, Childbirth and Puerperal Disorders
• Interventions: Other: postpartum female pelvic floor muscle affection; Other: postpartum sexual function in Egyptian women.

• Registration Number: NCT02338219
• Lead Sponsor: Al-Azhar University

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

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: 2014-02
• Study First Submitted: 2014-08-22
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-11
• Last Update Submitted: 2015-01-11
• Study First Posted: 2015-01-14
• Last Update Posted: 2015-01-14

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

• 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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vaginal delivery	postpartum sexual function in Egyptian women.	postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
urgent cesarean section	postpartum female pelvic floor muscle affection	postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
elective cesarean section	postpartum sexual function in Egyptian women.	postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
vaginal delivery	postpartum female pelvic floor muscle affection	postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
elective cesarean section	postpartum female pelvic floor muscle affection	postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound had worst morbidity after normal vaginal delivery	early postpartum period (48 to 72) hours postpartum

Secondary Outcome Measures

Name	Time	Method
Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery	at 3 months after delivery