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

September 17, 2014 updated by: Muhamed Osman, Al-Azhar University

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: early postpartum period (48 to 72) hours postpartum
early postpartum period (48 to 72) hours postpartum
Sexual function of pelvic floor as assessed by the validated female sexual function index
Time Frame: at 3 months after delivery
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
Time Frame: 6 months after delivery.
6 months after delivery.
Sexual function as assessed by the validated female sexual function index
Time Frame: 3 months after delivery
3 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 1781956

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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