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CompletedNCT02338219Updated Jan 14, 2015

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

A Phase 1/2 interventional study of postpartum female pelvic floor muscle affection and postpartum sexual function in Egyptian women. in Pregnancy, Childbirth and Puerperal Disorders, sponsored by Al-Azhar University. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by Al-Azhar University · Phase 1/2, Interventional, and Diagnostic

Phase
Phase 1/2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
Female
01

Study summary

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.

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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Keywords

  • postpartum pelvic floor
03

In context

Puerperal Disorders

40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.

This study's enrollment of 120 is above the median of 81 across 32 interventional studies indexed under Puerperal Disorders.

Browse Puerperal Disorders studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    vaginal delivery

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

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

  • Active comparator
    elective cesarean section

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

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

  • Active comparator
    urgent cesarean section

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

    Other: postpartum female pelvic floor muscle affection

Interventions

  • Otherpostpartum 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.

  • Otherpostpartum 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2014
First posted
Jan 14, 2015
Start
May 2013
Primary completionActual
Feb 2014
CompletionActual
Feb 2014
Last update
Jan 14, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02338219
Responsible party
Edessy Mahmoud (al-azhar unversity (assuit), faculty of medicine, obstetrics and gynecology department, Al-Azhar University) — Principal investigator
First posted
Jan 14, 2015
Start date
May 2013
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Jan 14, 2015

Study contacts

Mahmoud Edessy, prof
principal investigator · Al-Azhar University
Muhamed Osman Osman
study chair · 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 Jan 2015. You cannot join it, but the record below documents what was studied.

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