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CompletedNCT02245386Updated Sep 19, 2014

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

An observational study in Pregnancy, Childbirth and Puerperal Disorders, sponsored by Al-Azhar University. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
120
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Pregnancy, Childbirth and Puerperal Disorders

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

  • primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.

Exclusion criteria

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.
04

Study design

Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    (40 women after normal vaginal delivery) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.

    Radiation: transperineal pelvic floor ultrasound

  • 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

Interventions

  • Radiationtransperineal 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.

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT02245386
Lead sponsor
Al-Azhar University
Responsible party
Muhamed Osman (Dr, Al-Azhar University) — Principal investigator
First posted
Sep 19, 2014
Start date
May 2013
Primary completion
Feb 2014
Completion
Apr 2014
Last update
Sep 19, 2014

Study contacts

Muhamed Osman, Ms
principal investigator · Al-Azhar University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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