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

Pregnancy, Childbirth and Puerperal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245386
• Other study ID #: 1781956
• Status: Completed
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 17, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pregnancy, Childbirth and Puerperal Disorders
• Puerperal Disorders

Intervention

Radiation:
• transperineal pelvic floor ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound		early postpartum period (48 to 72) hours postpartum	No
Primary	Sexual function of pelvic floor as assessed by the validated female sexual function index		at 3 months after delivery	No
Secondary	Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound		6 months after delivery.	No
Secondary	Sexual function as assessed by the validated female sexual function index		3 months after delivery	No