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

NCT ID: NCT02338219

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy, Childbirth and Puerperal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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vaginal delivery

postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.

Group Type ACTIVE_COMPARATOR

postpartum female pelvic floor muscle affection

Intervention Type OTHER

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.

Intervention Type OTHER

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

elective cesarean section

postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.

Group Type ACTIVE_COMPARATOR

postpartum female pelvic floor muscle affection

Intervention Type OTHER

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.

Intervention Type OTHER

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

urgent cesarean section

postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women.

Group Type ACTIVE_COMPARATOR

postpartum female pelvic floor muscle affection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Edessy Mahmoud

al-azhar unversity (assuit), faculty of medicine, obstetrics and gynecology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Edessy, prof

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Muhamed Osman Osman

Role: STUDY_CHAIR

Al-Azhar University

Other Identifiers

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U1111-1159-6256

Identifier Type: -

Identifier Source: org_study_id

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