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CompletedNCT04076904Updated May 22, 2020

Cesarean Niche Examination by Transvaginal us

An observational study in Cesarean Section; Dehiscence, sponsored by Aljazeera Hospital. Completed at 2 sites in Egypt. Open to female participants aged 20 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by Aljazeera Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
110
Ages
20 Years to 42 Years
Sex
Female
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Study summary

The developed uterine scar developing due to cesarean section is usually clinically evaluated and visualized by transvaginal sonography (TVS) and saline infusion sonography (SIS) or Gel installation sonography (GIS)

Read the detailed description

In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal

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Conditions studied

  • Cesarean Section; Dehiscence
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In context

Lead sponsor

Aljazeera Hospital is the lead sponsor of 63 studies on the registry; 2 are open to participants now.

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

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Who can participate

Ages eligible
20 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal,

Inclusion criteria

  • women with secondary infertility

Exclusion criteria

Exclusion Criteria:

  • obstructed labor, pregnant women having chronic diseases;
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
110 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testtransvaginal us with 2D and 3D SHG

    transvaginal us is made to all women with SHG

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What researchers measure

Primary outcomes

  1. The number of women who will have dehesent scar

    transvaginal us showing lower segment with assessing scar

    Time frame: within a week

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Study locations

2 sites
  • Algazeerah and Kasralainy hospital
    Giza, Egypt
  • Algazeerah
    Giza, Egypt
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References and documents

Publications

  • Alalfy M, Osman OM, Salama S, Lasheen Y, Soliman M, Fikry M, Ramadan M, Alaa D, Elshemy S, Abdella R. Evaluation of the Cesarean Scar Niche In Women With Secondary Infertility Undergoing ICSI Using 2D Sonohysterography Versus 3D Sonohysterography and Setting a Standard Criteria; Alalfy Simple Rules for Scar Assessment by Ultrasound To Prevent Health Problems for Women. Int J Womens Health. 2020 Nov 3;12:965-974. doi: 10.2147/IJWH.S267691. eCollection 2020. PubMed 33177887 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04076904
Lead sponsor
Aljazeera Hospital
Responsible party
Mahmoud Alalfy (Researcher , lecturer ,Obstetrics and Gynecology , National Research Centre, Aljazeera Hospital) — Principal investigator
First posted
Sep 4, 2019
Start date
Oct 1, 2019
Primary completion
Jan 25, 2020
Completion
Jan 28, 2020
Last update
May 22, 2020

Study contacts

Mahmoud Alalfy, PhD
study chair · Algezeera hospitaland National Research Centre ,Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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