Cesarean Section; DehiscenceNCT04070118
Lower Uterine Segment Thickness and Term Pain,Previous Cesarean Section
An observational study of Cesarean Section; Dehiscence and Cesarean Section Complications, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
the purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence, Cesarean Section Complications
- What is being tested?
- Measure niche thickness with ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In Pregnant Women with Term Pain and Previous Cesarean Section; Patients with visual evaluation of the lower uterine segment thickness and ultrasound
Who may be able to join
- Patients with a previous cesarean section
- Those in term gestational week (37-42 weeks)
- Those who apply to the emergency with pain
Who cannot join
- Birden fazla sezaryen geçirilmiş öyküsü olan hastalar
- Önceden geçirilmiş uterin cerrahisi olan hastalar
- Miad olmayan gebeler
- Plesantal yerleşim patolojısı olan gebeler
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Evaluation of Lower Uterine Segment Thickness in Pregnant Women Presenting With Term Pain and Previous Cesarean Section
the purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy.
If patients who have had previous cesarean section present to the emergency department with pain or NST pain, a panic occurs immediately for operation. Purpose of researchers; The aim of this study is to investigate whether a really fine determination of the thickness of the old incision line is associated with full-thickness rupture or incomplete rupture, which appears to be an operation, and if a relationship is found, there is a limit for this thickness.
- Being tested
- Measure niche thickness with ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure niche thickness with ultrasoundProcedure or surgery
in patients with previous cesarean section who applied to the emergency department with pain and underwent surgery; Measure niche thickness before operation
| Study group | Role | What they receive |
|---|---|---|
| patients with previous cesarean section | presenting to the emergency department with pain, previous cesarean section; Patients measured niche thickness before operation Receives: Procedure: Measure niche thickness with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure niche thickness with ultrasound
Ultrasonography of Lower Uterine Segment Thickness in Pregnant Women Presenting with Term Pain and Previous Cesarean Section It will be given in mm.
Measured: 1 day
Measure niche thickness with visual evaluation of the surgeon
Measured Lower Uterine Segment Thickness by Visual Evaluation of Pregnant Women Presenting with Term Pain and Previous Cesarean Section no rupture have full coat rupture have incomplete rupture; will be valued as.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070118
- Sponsor's protocol ID
- 2019.05.117
- Status last verified
- Jan 2020
- First submitted
- 24 Aug 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lower Uterine Segment Thickness in Pregnant Women Presenting With Term Pain and Previous Cesarean Section
- ClinicalTrials.gov ID
- NCT04070118
- Acronym / sponsor ID
- 2019.05.117
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 28 Aug 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 purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy.
If patients who have had previous cesarean section present to the emergency department with pain or NST pain, a panic occurs immediately for operation. Purpose of researchers; The aim of this study is to investigate whether a really fine determination of the thickness of the old incision line is associated with full-thickness rupture or incomplete rupture, which appears to be an operation, and if a relationship is found, there is a limit for this thickness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with previous cesarean section | – | Procedure: Measure niche thickness with ultrasoundpresenting to the emergency department with pain, previous cesarean section; Patients measured niche thickness before operation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In Pregnant Women with Term Pain and Previous Cesarean Section; Patients with visual evaluation of the lower uterine segment thickness and ultrasound
Key inclusion criteria (3 listed)
- Patients with a previous cesarean section
- Those in term gestational week (37-42 weeks)
- Those who apply to the emergency with pain
Key exclusion criteria (4 listed)
- Birden fazla sezaryen geçirilmiş öyküsü olan hastalar
- Önceden geçirilmiş uterin cerrahisi olan hastalar
- Miad olmayan gebeler
- Plesantal yerleşim patolojısı olan gebeler
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 |
|---|---|---|
| Measure niche thickness with ultrasoundin patients with previous cesarean section who applied to the emergency department with pain and underwent surgery; Measure niche thickness before operation | Procedure or surgery | patients with previous cesarean section |
Primary outcome
Measure niche thickness with ultrasound
Time frame: 1 day
Ultrasonography of Lower Uterine Segment Thickness in Pregnant Women Presenting with Term Pain and Previous Cesarean Section It will be given in mm.
Measure niche thickness with visual evaluation of the surgeon
Time frame: 1 day
Measured Lower Uterine Segment Thickness by Visual Evaluation of Pregnant Women Presenting with Term Pain and Previous Cesarean Section no rupture have full coat rupture have incomplete rupture; will be valued as.
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 18 Jan 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
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; Dehiscence and Cesarean Section Complications, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 18 Jan 2020. 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 Turkey (Türkiye). 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?
Measure niche thickness with ultrasound (time frame: 1 day). The study lists 2 primary outcomes in all. 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 18 Jan 2020.