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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Childbirth and Puerperal Disorders
• Intervention / Treatment: Radiation: transperineal pelvic floor ultrasound

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 Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Muhamed Osman, Ms, Al-Azhar University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Puerperal Disorders
• Other Study ID Numbers: 1781956