Cesarean SectionNCT05900492
Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery
An observational study of Cesarean Section and Dehiscence, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Dehiscence
- What is being tested?
- cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.
Who may be able to join
- Delivery by cesarean section.
- More than 6 months after delivery.
- Cesarean section by senior resident or assistant lecturer.
Who cannot join
- Single layer technique in uterine closure.
- Uterine anomaly.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery and Assessment of Its Risk Factors
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
- Conditions
- Cesarean Section, Dehiscence
- Being tested
- cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean sectionProcedure or surgery
caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen
| Study group | Role | What they receive |
|---|---|---|
| previous 1 cesarean section | patient who had her first Cesarean section Receives: Procedure: cesarean section | |
| previous 2 cesarean sections | patient who had her second Cesarean sections Receives: Procedure: cesarean section | |
| previous 3 or more cesarean sections | patient who had 3 or more Cesarean sections Receives: Procedure: cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of cesarean scar niche among cesarean deliveries
number of cases develop cesarean scar niche after cesarean deliveries
Measured: 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)
Measured: within 1 month of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- sara M salem, MD, Principal investigator, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900492
- Sponsor's protocol ID
- cesarean scar niche R.F
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery and Assessment of Its Risk Factors
- ClinicalTrials.gov ID
- NCT05900492
- Acronym / sponsor ID
- cesarean scar niche R.F
- Conditions
- Cesarean Section, Dehiscence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| previous 1 cesarean section | – | Procedure: cesarean sectionpatient who had her first Cesarean section |
| previous 2 cesarean sections | – | Procedure: cesarean sectionpatient who had her second Cesarean sections |
| previous 3 or more cesarean sections | – | Procedure: cesarean sectionpatient who had 3 or more Cesarean sections |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.
Key inclusion criteria (3 listed)
- Delivery by cesarean section.
- More than 6 months after delivery.
- Cesarean section by senior resident or assistant lecturer.
Key exclusion criteria (2 listed)
- Single layer technique in uterine closure.
- Uterine anomaly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cesarean sectioncaesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen | Procedure or surgery | previous 1 cesarean section, previous 2 cesarean sections, previous 3 or more cesarean sections |
Primary outcome
the incidence of cesarean scar niche among cesarean deliveries
Time frame: 6 months after delivery
number of cases develop cesarean scar niche after cesarean deliveries
1 secondary outcome
risk factors that affect the development of the niche.
Time frame: within 1 month of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sara M salem, MD principal investigator
Faculty of Medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Dehiscence, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of cesarean scar niche among cesarean deliveries (time frame: 6 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.