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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

mona_fouad_2000@hotmail.com

Egypt1 site
  • Kasr Alainy medical school

    Cairo, Cairo Governorate, 12151

Other trials in Egypt

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.

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 groups in NCT03111706
Study groupRoleWhat they receive
dehiscencd scarwomen who are discovered with scar dehiscence during cesarean section
Receives: Procedure: Cesarean section
Intact scarwomen 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.

  1. 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.

  1. First posted13 Apr 2017
  2. Study startMay 2017 (estimated)
  3. Primary completionMay 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

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)
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

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.

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