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Completed

NCT Number: NCT02245386

Effects of Pregnancy and Childbirth 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.

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Key information

Conditions

Pregnancy, Childbirth and Puerperal Disorders Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Puerperal Disorders Urogenital Diseases

Sex eligibility

Female

Study type

Observational

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transperineal pelvic floor ultrasound

Radiation

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.

Primary outcomes

  1. Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound

    Time frame: early postpartum period (48 to 72) hours postpartum

  2. Sexual function of pelvic floor as assessed by the validated female sexual function index

    Time frame: at 3 months after delivery

Secondary outcomes

  1. Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound

    Time frame: 6 months after delivery.

  2. Sexual function as assessed by the validated female sexual function index

    Time frame: 3 months after delivery

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2014
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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