Cesarean Section ComplicationsisthmoceleNCT04605328
Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms
An observational study of Cesarean Section Complications, run by Assiut University.
Trial summary
The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Two dimension and three dimension ultrasound
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 30 Dec 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted to Women Health Hospital for performing CS will be seen on regular visits for ultrasound scan for detection of CSD
Who may be able to join
- All women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and Emergency), after counseling and written consent
Who cannot join
- Rupture uterus (unscarred or scarred).
- Upper segment CS.
- Vertical lower segment CS.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms: A Cohort Observational Study
The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.
Read the detailed description
All eligible women, who will undergo CS in Women Health Hospital (WHH) will be seen on regular visits to detect the presence of CSD by ultrasound and identify its characters and a questionnaire will be fulfilled by the candidates about the gynecological symptoms related to CSD and appeared after CS.
- Conditions
- Cesarean Section Complications
- Being tested
- Two dimension and three dimension ultrasound
- Keywords
- niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two dimension and three dimension ultrasoundOther
Patient will undergo 2D and 3D ultrasound evaluation after CS for detection of CSD
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of CSD in Women health Hospital
the incidence of CSD in Women health Hospital
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Bahaa, Assiut University
- Investigators
- Ayman shamaash, PHD, Study director, Assiut UniversitySherif Badran, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605328
- Sponsor's protocol ID
- Cesarean scar defect
- Acronym
- isthmocele
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms: A Cohort Observational Study
- ClinicalTrials.gov ID
- NCT04605328
- Acronym / sponsor ID
- isthmocele / Cesarean scar defect
- Conditions
- Cesarean Section Complications
- Keywords
- niche
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 28 Oct 2020 (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.
The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.
Detailed description
All eligible women, who will undergo CS in Women Health Hospital (WHH) will be seen on regular visits to detect the presence of CSD by ultrasound and identify its characters and a questionnaire will be fulfilled by the candidates about the gynecological symptoms related to CSD and appeared after CS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to Women Health Hospital for performing CS will be seen on regular visits for ultrasound scan for detection of CSD
Key inclusion criteria (1 listed)
- All women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and Emergency), after counseling and written consent
Key exclusion criteria (3 listed)
- Rupture uterus (unscarred or scarred).
- Upper segment CS.
- Vertical lower segment CS.
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 |
|---|---|---|
| Two dimension and three dimension ultrasoundPatient will undergo 2D and 3D ultrasound evaluation after CS for detection of CSD | Other | – |
Primary outcome
the incidence of CSD in Women health Hospital
Time frame: 1 year
the incidence of CSD in Women health Hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Ayman shamaash, PHD study director
Assiut University
Sherif Badran, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Assiut University.
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 1 inclusion and 3 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Bahaa El-Dine, Master (++201022422960, midobahaa39@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of CSD in Women health Hospital (time frame: 1 year). 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 3 Nov 2020.