Cesarean Wound DisruptionNCT03111706
2D and 3D Ultrasound Assessment of Cesarean Section Scars
An observational study of Cesarean Wound Disruption, run by Cairo University at 1 site in Egypt.
Trial summary
Prospective observational study conducted on women with previous 1 or 2 CS candidate for elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively Read more about this study
- Who is it for?
- Ages 19 to 44 years, women only
- Conditions the study is for
- Cesarean Wound Disruption
- What is being tested?
- Cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- May 2017to Jul 2018
- 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 19 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: women with prior 1 or 2 cesarean sections candidate for elective cesarean sewction
Who may be able to join
- 37 - 40 weeks of gestational age
- singleton pregnancy,
- cephalic presentation,
- not in labor
- intact membranes
- with history of one or two previous CS
Who cannot join
- disorders of amniotic fluid,
- placenta previa
- history of other uterine surgery, e.g, myomectomy
Trial locations and contacts
1 site in 1 country.
Mona Fouad, MD contact
About this study
Official title: 2D and 3D Ultrasound Assessment of Cesarean Section Scars and Its Correlation to Intraoperative Findings
Prospective observational study conducted on women with previous 1 or 2 CS candidate for elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively
Read the detailed description
Transabdominal ultrasound examination to obtain full obstetric ultrasound report including estimated gestational age, fetal lie, presentation, amniotic fluid volume, placental location with special focus on relation to the uterine scar.
The second step was to measure the thickness of the LUS using 2D ultrasound. View of the LUS was obtained in the mid-sagittal plane and the view was magnified looking for the thinnest area of the LUS. Also, the LUS was examined in a lateral view to detect any apparent rupture, ballooning or funneling. The measurement was taken with the cursors at the urine-Urinary bladder interface and the amniotic fluid -decidua interface after sufficient magnification and measurement was taken to the nearest tenth of millimeter. The numeric display was covered during the examination to avoid bias when performing the 3D measurement in the next step. Three measurements were taken and the least measurement was recorded.
After the entire thickness was measured by 2D ultrasound, 3 D measurement were taken in the mid-saggittal plan using the multiplanar display mode and then moving through the acquired 3-D volume in the saggittal plane till the thinnest area was seen and then measurements were taken.3-D volume dataset was obtained of the LUS by the same operator. The acquired volume was manipulated on the multiplanar display mode, searching for the thinnest part of the LUS avoiding obliquity.
Transvaginal ultrasound examination was done following the transabdominal one. The vaginal probe was inserted into the posterior vaginal fornix with the patient lying supine and the patient's knees are gently flexed and hips are slightly elevated with a pillow. Clear view of the LUS was obtained in the midsagittal plane visualizing the cervical canal to ensure that the view is midline one and avoiding obliquity.
On transvaginal examination the muscular layer of the LUS was clearly seen as hypoechoic line between the hyperechoic uterovesical fold and the decidualized endometrium and the chorioamniotic membranes. The scar area was magnified so the scar occupies at least 75% of the image to ensure consistent and accurate measurements. The thickness of the muscular layer of LUS was taken with the measuring caliber placed at the urinary bladder wall-myometrium interface and the myometrial/ chorioamniotic membrane interface .Three measurements of the LUS were taken, and again, the least measurement was recorded.
Again, 3D volume data set of the LUS was obtained .The acquired volume was manipulated on the multiplanar display looking for the thinnest part of the muscular layer. The thickness was measured to the nearest tenth of millimeter and recorded. The same operator has performed the transabdominal and transvaginal sonographic examination, and the surgeon performing the CS was always blinded of the sonographic findings.
The ultrasound examination to CS time interval varied from one to forty eight hours. During Cesarean delivery the LUS was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
- Conditions
- Cesarean Wound Disruption
- 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
During Cesarean delivery the lower uterine segment (LUS) was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
| Study group | Role | What they receive |
|---|---|---|
| dehiscencd scar | women who are discovered with scar dehiscence during cesarean section Receives: Procedure: Cesarean section | |
| Intact scar | women with intact scar detected during cesarean section Receives: Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar dehiscence
as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Wound DisruptionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111706
- Sponsor's protocol ID
- 165
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2017
- Last updated
- 14 Apr 2017
- 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 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2D and 3D Ultrasound Assessment of Cesarean Section Scars and Its Correlation to Intraoperative Findings
- ClinicalTrials.gov ID
- NCT03111706
- Acronym / sponsor ID
- 165
- Conditions
- Cesarean Wound Disruption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 13 Apr 2017 (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.
Prospective observational study conducted on women with previous 1 or 2 CS candidate for elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively
Detailed description
Transabdominal ultrasound examination to obtain full obstetric ultrasound report including estimated gestational age, fetal lie, presentation, amniotic fluid volume, placental location with special focus on relation to the uterine scar.
The second step was to measure the thickness of the LUS using 2D ultrasound. View of the LUS was obtained in the mid-sagittal plane and the view was magnified looking for the thinnest area of the LUS. Also, the LUS was examined in a lateral view to detect any apparent rupture, ballooning or funneling. The measurement was taken with the cursors at the urine-Urinary bladder interface and the amniotic fluid -decidua interface after sufficient magnification and measurement was taken to the nearest tenth of millimeter. The numeric display was covered during the examination to avoid bias when performing the 3D measurement in the next step. Three measurements were taken and the least measurement was recorded.
After the entire thickness was measured by 2D ultrasound, 3 D measurement were taken in the mid-saggittal plan using the multiplanar display mode and then moving through the acquired 3-D volume in the saggittal plane till the thinnest area was seen and then measurements were taken.3-D volume dataset was obtained of the LUS by the same operator. The acquired volume was manipulated on the multiplanar display mode, searching for the thinnest part of the LUS avoiding obliquity.
Transvaginal ultrasound examination was done following the transabdominal one. The vaginal probe was inserted into the posterior vaginal fornix with the patient lying supine and the patient's knees are gently flexed and hips are slightly elevated with a pillow. Clear view of the LUS was obtained in the midsagittal plane visualizing the cervical canal to ensure that the view is midline one and avoiding obliquity.
On transvaginal examination the muscular layer of the LUS was clearly seen as hypoechoic line between the hyperechoic uterovesical fold and the decidualized endometrium and the chorioamniotic membranes. The scar area was magnified so the scar occupies at least 75% of the image to ensure consistent and accurate measurements. The thickness of the muscular layer of LUS was taken with the measuring caliber placed at the urinary bladder wall-myometrium interface and the myometrial/ chorioamniotic membrane interface .Three measurements of the LUS were taken, and again, the least measurement was recorded.
Again, 3D volume data set of the LUS was obtained .The acquired volume was manipulated on the multiplanar display looking for the thinnest part of the muscular layer. The thickness was measured to the nearest tenth of millimeter and recorded. The same operator has performed the transabdominal and transvaginal sonographic examination, and the surgeon performing the CS was always blinded of the sonographic findings.
The ultrasound examination to CS time interval varied from one to forty eight hours. During Cesarean delivery the LUS was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dehiscencd scar | – | Procedure: Cesarean sectionwomen who are discovered with scar dehiscence during cesarean section |
| Intact scar | – | Procedure: Cesarean sectionwomen with intact scar detected during cesarean section |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with prior 1 or 2 cesarean sections candidate for elective cesarean sewction
Key inclusion criteria (6 listed)
- 37 - 40 weeks of gestational age
- singleton pregnancy,
- cephalic presentation,
- not in labor
- intact membranes
Key exclusion criteria (3 listed)
- disorders of amniotic fluid,
- placenta previa
- history of other uterine surgery, e.g, myomectomy
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 sectionDuring Cesarean delivery the lower uterine segment (LUS) was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture. | Procedure or surgery | Intact scar, dehiscencd scar |
Primary outcome
Scar dehiscence
Time frame: At time of surgery
as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Wound Disruption
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Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section
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Not yet recruitingObservational study
Ultrasound Model to Help Differentiate Between Placenta Accreta Spectrum and Uterine Dehiscence in 3rd Trimester Pregnancies
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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.
Mona Fouad, MD contact
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
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 Wound Disruption, run by Cairo 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 6 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 14 Apr 2017. 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?
Contact Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar dehiscence (time frame: At time of surgery). 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 14 Apr 2017.