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

January 11, 2015 updated by: Edessy Mahmoud, Al-Azhar University
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.

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

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 1

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

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:

  • 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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vaginal delivery
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
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.
Other: 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.
Active Comparator: elective cesarean section
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
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.
Other: 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.
Active Comparator: urgent cesarean section
postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.
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.

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 had worst morbidity after normal vaginal delivery
Time Frame: early postpartum period (48 to 72) hours postpartum
early postpartum period (48 to 72) hours postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery
Time Frame: at 3 months after delivery
at 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: Mahmoud Edessy, prof, Al-Azhar University
  • Study Chair: Muhamed Osman Osman, 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)

February 1, 2014

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

January 11, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 11, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1159-6256

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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