CClinicalTrials.gg
Active, not recruitingNCT05900492Updated Jun 13, 2023

Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery

An observational study in Cesarean Section and Dehiscence, sponsored by Beni-Suef University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by Beni-Suef University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.

Read the detailed description

It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital using Ultrasound:

Six months after the cesarean delivery, participants will be invited to the gynecologic outpatient clinic or department for ultrasound (US) examination to detect the presence of the niche.

Women without contraception will be examined during the follicular phase of the menstrual cycle to avoid an eventual early pregnancy. Otherwise, a random phase of the menstrual cycle will be accepted. Women who are pregnant at the time of US will be excluded. Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way, with trans-vaginal US performed first.

For the diagnosis of cesarean scar niche (defined as an anechoic defect in the anterior wall of the lower uterine segment, communicating with the endometrial cavity),we will use a predetermined definition of a defect at least 2.0 mm deep

02

Conditions studied

  • Cesarean Section
  • Dehiscence
03

In context

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.

Inclusion criteria

  1. Delivery by cesarean section.
  2. More than 6 months after delivery.
  3. Cesarean section by senior resident or assistant lecturer.

Exclusion criteria

Exclusion Criteria:

  1. Single layer technique in uterine closure.
  2. Uterine anomaly.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • previous 1 cesarean section

    patient who had her first Cesarean section

    Procedure: cesarean section

  • previous 2 cesarean sections

    patient who had her second Cesarean sections

    Procedure: cesarean section

  • previous 3 or more cesarean sections

    patient who had 3 or more Cesarean sections

    Procedure: cesarean section

Interventions

  • Procedurecesarean section

    caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

06

What researchers measure

Primary outcomes

  1. the incidence of cesarean scar niche among cesarean deliveries

    number of cases develop cesarean scar niche after cesarean deliveries

    Time frame: 6 months after delivery

Secondary outcomes

  1. risk factors that affect the development of the niche.

    age- BMI- post operative infection - PROM(preterm rupture of membrane)

    Time frame: within 1 month of delivery

07

Study locations

1 site
  • Beni-suef university Hospital
    Banī Suwayf, Beni Suef 62521, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05900492
Lead sponsor
Beni-Suef University
Responsible party
Sara Abdallah Mohamed Salem (principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University) — Principal investigator
First posted
Jun 12, 2023
Start date
Jan 1, 2023
Primary completion
Sep 30, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Jun 13, 2023

Study contacts

sara M salem, MD
principal investigator · Faculty of Medicine Beni-Suef University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion