Cesarean Section; DehiscenceNCT04076904
Cesarean Niche Examination by Transvaginal us
An observational study of Cesarean Section; Dehiscence, run by Aljazeera Hospital at 2 sites in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- transvaginal us with 2D and 3D SHG
- How many people
- 110 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2019to 28 Jan 2020
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
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,
Who may be able to join
- women with secondary infertility
Who cannot join
- obstructed labor, pregnant women having chronic diseases;
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Cesarean Niche Examination by us to Assess Its Integrity and Dehescence
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
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- transvaginal us with 2D and 3D SHG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal us with 2D and 3D SHGDiagnostic test
transvaginal us is made to all women with SHG
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will have dehesent scar
transvaginal us showing lower segment with assessing scar
Measured: within a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Oct 2019
- Primary completion25 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076904
- Sponsor's protocol ID
- cesarean niche
- Status last verified
- May 2020
- First submitted
- 30 Aug 2019
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Niche Examination by us to Assess Its Integrity and Dehescence
- ClinicalTrials.gov ID
- NCT04076904
- Acronym / sponsor ID
- cesarean niche
- Conditions
- Cesarean Section; Dehiscence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 4 Sep 2019 (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 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)
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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,
Key inclusion criteria (1 listed)
- women with secondary infertility
Key exclusion criteria (1 listed)
- obstructed labor, pregnant women having chronic diseases;
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 |
|---|---|---|
| transvaginal us with 2D and 3D SHGtransvaginal us is made to all women with SHG | Diagnostic test | – |
Primary outcome
The number of women who will have dehesent scar
Time frame: within a week
transvaginal us showing lower segment with assessing scar
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Derived from this study: PubMed 33177887Alalfy 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.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section; Dehiscence
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Not yet recruiting
Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section
Cesarean Section; Complications, Wound, Dehiscence
Recruiting
Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
Cesarean Section, Surgical Site Infection
Active, not recruitingObservational study
The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction
Cesarean Section; Dehiscence
Recruiting
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
Cesarean Section; Dehiscence
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.
Mahmoud Alalfy, PhD study chair
Algezeera hospitaland National Research Centre ,Egypt
2 sites 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; Dehiscence, run by Aljazeera Hospital at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 number of women who will have dehesent scar (time frame: within a week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076904, which also lists 1 linked publication.
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 22 May 2020.