Cesarean Scar NicheNCT03609281
Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries
An observational study of Cesarean Scar Niche and Cesarean Wound; Dehiscence, run by Tanta University at 1 site in Egypt.
Trial summary
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Scar Niche, Cesarean Wound; Dehiscence, Cesarean Section; Dehiscence
- What is being tested?
- Ultrasound assessement of uterine scar
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 31 Mar 2019
- How long will I take part?
- 6 Months
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients will be selected according to inclusion and exclusion criteria.
Who may be able to join
- Primipara delivered by cs
- Multipara with last delivery by cs
- Full term delivery >37 weeks
- Double layer cesarean repair
- Pfannenstiel incison
Who cannot join
- Repeat cs
- Any placental abnormalities
- Preterm delivery
- Single layer cesarean repair
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.
Read the detailed description
design and settings: This study is a descriptive, cross-sectional and multicenter study conducted at Tanta and Benha Universities, Egypt in the period from August, 1, 2018 to December, 31, 2018.
Patients:
Eligibility: Nine hundred patients were selected carefully according to inclusion and exclusion criteria. The inclusion criteria were: (i) Primipara having prior cesarean delivery whether scheduled or emergency (ii) Term delivery ≥ 37 weeks of gestation (iii) Multipara having the last delivery by cesarean either scheduled or emergency (iv) The interval following cesarean delivery to be 6 months at least and (v) Double-layer repair of uterus and (vi) Cesarean by pfannensteil incisions. The exclusion criteria were: (i) Repeat cesarean sections (ii) Preterm delivery (iii) Associated placental abnormalities (iv) Single-layer repair of uterus and (v) Refusal to participate.
Allocations: This study is not a clinical trial so allocation is made based on characteristics of patients and eligibility to be allocated in either scheduled cesarean group or emergency cesarean group. The allocation was not equal based on the percentage of patients in either group. The scheduled cesarean group included 580 cases while the emergency cesarean group included 320 cases from both universities.
Intervention: Cesarean scar assessment included both uterine scar and cutaneous scar. The uterine scar was assessed by transvaginal 3D ultrasound. The used device in both universities was DC-30 device of Mindray Company. All ultrasound examinations were conducted by third author in this study. Cutaneous scar was assessed by surgery department represented by the fourth author in this study. The uterine scar in both groups was examined for distance from internal os, length, thickness, volume, vasculature and presence of any defects. Cutaneous scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.
- Being tested
- Ultrasound assessement of uterine scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessement of uterine scarRadiation
3D ultrasound assessment of scar characteristics
| Study group | Role | What they receive |
|---|---|---|
| Scheduled cesaren group | Patient delivered by elective cesarean section without labour pains Receives: Radiation: Ultrasound assessement of uterine scar | |
| Emergency cesarean group | Patients delivered by cesarean section due to an emergency Receives: Radiation: Ultrasound assessement of uterine scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar characteristics
Site of scar in relation to internal os of cervix
Measured: 6 months
Scar length
length of scar in mm
Measured: 6 months
thickness of scar
Scar depth in mm
Measured: 6 months
Scar volume
Length multiplied by width multiplied by depth
Measured: 6 months
Scar vascularity
Doppler on scar to assess vascularity
Measured: 6 month
Secondary outcomes (1)
Scar defect or niche
Assessment of scar weakness or scar defect by ultrasound with measurement of depth, width and length of defects plus the residual myometrial tissue
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar NicheStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Cross-sectional
- Enrolment
- 900 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609281
- Sponsor's protocol ID
- Ayman CS Scar
- Status last verified
- Apr 2019
- First submitted
- 15 Jul 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are secret
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study
- ClinicalTrials.gov ID
- NCT03609281
- Acronym / sponsor ID
- Ayman CS Scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 Aug 2018 (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.
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.
Detailed description
design and settings: This study is a descriptive, cross-sectional and multicenter study conducted at Tanta and Benha Universities, Egypt in the period from August, 1, 2018 to December, 31, 2018.
Patients:
Eligibility: Nine hundred patients were selected carefully according to inclusion and exclusion criteria. The inclusion criteria were: (i) Primipara having prior cesarean delivery whether scheduled or emergency (ii) Term delivery ≥ 37 weeks of gestation (iii) Multipara having the last delivery by cesarean either scheduled or emergency (iv) The interval following cesarean delivery to be 6 months at least and (v) Double-layer repair of uterus and (vi) Cesarean by pfannensteil incisions. The exclusion criteria were: (i) Repeat cesarean sections (ii) Preterm delivery (iii) Associated placental abnormalities (iv) Single-layer repair of uterus and (v) Refusal to participate.
Allocations: This study is not a clinical trial so allocation is made based on characteristics of patients and eligibility to be allocated in either scheduled cesarean group or emergency cesarean group. The allocation was not equal based on the percentage of patients in either group. The scheduled cesarean group included 580 cases while the emergency cesarean group included 320 cases from both universities.
Intervention: Cesarean scar assessment included both uterine scar and cutaneous scar. The uterine scar was assessed by transvaginal 3D ultrasound. The used device in both universities was DC-30 device of Mindray Company. All ultrasound examinations were conducted by third author in this study. Cutaneous scar was assessed by surgery department represented by the fourth author in this study. The uterine scar in both groups was examined for distance from internal os, length, thickness, volume, vasculature and presence of any defects. Cutaneous scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled cesaren group | – | Radiation: Ultrasound assessement of uterine scarPatient delivered by elective cesarean section without labour pains |
| Emergency cesarean group | – | Radiation: Ultrasound assessement of uterine scarPatients delivered by cesarean section due to an emergency |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients will be selected according to inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Primipara delivered by cs
- Multipara with last delivery by cs
- Full term delivery >37 weeks
- Double layer cesarean repair
- Pfannenstiel incison
Key exclusion criteria (5 listed)
- Repeat cs
- Any placental abnormalities
- Preterm delivery
- Single layer cesarean repair
- Refusal to participate
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 |
|---|---|---|
| Ultrasound assessement of uterine scar3D ultrasound assessment of scar characteristics | Radiation | Emergency cesarean group, Scheduled cesaren group |
Primary outcome
Scar characteristics
Time frame: 6 months
Site of scar in relation to internal os of cervix
Scar length
Time frame: 6 months
length of scar in mm
thickness of scar
Time frame: 6 months
Scar depth in mm
Scar volume
Time frame: 6 months
Length multiplied by width multiplied by depth
Scar vascularity
Time frame: 6 month
Doppler on scar to assess vascularity
1 secondary outcome
Scar defect or niche
Time frame: 6 months
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 23 Apr 2019.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are secret
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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.
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 Scar Niche and Cesarean Wound; Dehiscence, run by Tanta 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 5 inclusion and 5 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 23 Apr 2019. 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?
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?
Scar characteristics (time frame: 6 months). The study lists 5 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 23 Apr 2019.