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

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT02245386

Collaborator

(none)

120

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Childbirth and Puerperal Disorders	Radiation: transperineal pelvic floor ultrasound

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	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.

Arm

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

Group 3

(40 women after elective cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.

Radiation: transperineal pelvic floor ultrasound

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.
Previous vaginal or cesarean delivery.
Severe mental illness.
Severe physical handicap or difficulties in communication.
Women without postpartum active sexual life or separate from their spouse.
Past history of sexual dysfunction.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Al-Azhar University

Investigators

Principal Investigator: Muhamed Osman, Ms, Al-Azhar University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhamed Osman, Dr, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT02245386

Other Study ID Numbers:

1781956

First Posted:

Sep 19, 2014

Last Update Posted:

Sep 19, 2014

Last Verified:

Sep 1, 2014

Additional relevant MeSH terms:

Puerperal Disorders

Study Results

No Results Posted as of Sep 19, 2014