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 Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338219
• Other study ID #: U1111-1159-6256
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 22, 2014
• Last updated: January 11, 2015
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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: February 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:

• 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pregnancy, Childbirth and Puerperal Disorders
• Puerperal Disorders

Intervention

Other:
• postpartum female pelvic floor muscle affection
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.
• postpartum sexual function in Egyptian women.
answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.

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 had worst morbidity after normal vaginal delivery		early postpartum period (48 to 72) hours postpartum	Yes
Secondary	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	Yes