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Obstetric Labor ComplicationsNCT03862820

Dynamic Ultrasound for Prediction of Adhesion Section

An observational study of Obstetric Labor Complications, run by Assiut University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

1. To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section. 2. To detect the interobserver and intraobserver reliability of this method Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obstetric Labor Complications
What is being tested?
dynamic ultrasound
How many people
150 participants
Where
No sites listed yet
Study dates
Apr 2019to Feb 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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: pregnant women planned for elective repeated section

Who may be able to join

  • Pregnant women in third trimester planned to undergo elective cesarean section

Who cannot join

  • Primary elective cesarean section.

Trial locations and contacts

No sites are listed yet.

About this study

Official title: The Use of Dynamic Ultrasound for Prediction of Adhesions in Women Undergoing Repeated Cesarean Section, an Observational Prospective Study

  1. To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
  2. To detect the interobserver and intraobserver reliability of this method
Read the detailed description

INTRODUCTION Cesarean section is life saving procedure that involve extraction of the baby from the abdomen of the mother for numerous fetal and maternal indications The rate of cesarean section has been rising dramatically in the last decade reaching up to 32 % of birth in USA in 2014 . The rate of cesarean section in Assiut university in Egypt reached about 38% in 2011.

Cesearen section is associated with many intraoperative and postoperative early and late complications. Early complications includes hemorrhage bladder and bowel injuries, sepsis and postoperative illeus . Remote complications include the occurrence of intraperitoneal adhesions.The incidence of adhesions varies according to many factors includes the number of previous cesarean section, type of suture material, hemostasis but usually incidence of adhesions after cesarean is between 12 and 75 % .

The presence of adhesions in repeated cesarean section increases the surgical difficulty and the incidence of bladder and bowel injuries . Multidisciplinary team should evaluate these patients before surgery. Few studies used ultrasound to evaluate the presence of adhesions before operation . However they either used transvaaginal ultrasound which may not be available or used a small sample size which does not reflect the value of this tool accurately. In our study we are trying to use transabdominal ultrasound on large sample size to evaluate the use of dynamic ultrasound perioperative in predicting adhesions.

AIM OF THE STUDY

  1. To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
  2. To detect the interobserver and intraobserver reliability of this method. PATIENTS AND METHODS
  • Study setting and population From February 2019 to February 2020, all women undergoing repeated cesarean section in both Assiut university hospital and El Eman hospital will be candidates for this study.
  • Study design The study will be blinded prospective observational study where investigator will perform ultrasound to recruited women before their elective cesarean section then the obstetrician who is blinded to the ultrasound results will be asked to fill a form postoperative to report the presence site and extent of adhesions.
  • Eligible participants Inclusion criteria Pregnant women in third trimester planned to undergo elective cesarean section ,

Exclusion criteria Primary elective cesarean section.

  • Interventions Pregnant women planned to do elective cesarean section will be examined by two examiners senior resident and the assistant lecturer on duty using Medison ultrasound 5 MHZ abdominal convex probe. The probe is placed on the site of previous cesarean incision then moved from above downward and from side to side and we ask the patient to breathe deeply then we record the movement of anterior uterine wall against anterior abdominal wall where positive sliding sign if the uterus move freely and negative sliding sign if there is limited mobility. Elective cesarean is done by the obstetrician on duty as scheduled who is blind to the ultrasound results and then we ask him to report if adhesions are absent or present and if present site and type of adhesions and the difficulty of cesarean in a subjective score from 0 to 10. Preoperative and postoperative hemoglobin level will be measured as an indirect indicator for the difficulty of cesarean section.
  • Sample size We need some work.
  • Statistical Analysis The data will be collected and entered on Microsoft access data base to be analyzed using the Statistical Package for Social Science (SPSS Inc., Chicago, version 16). Sensitivity, specificity, negative and positive predictive value for the sliding sign will be measured
  • Ethical aspect The study protocol will be submitted to Assiut medical school ethical board for approval. All participants will sign a written consent in the study after reading the patient information sheet or having it read for them if they cannot read or write. Confidentially of patient data will be secured in all stage of the study. Women who refuse participation in the study will not be affected by any mean regarding the quality of care in our service.
Being tested
dynamic ultrasound
Medical subject headings
Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dynamic ultrasoundDiagnostic test

    move abdomen with ultrasound probe to predict intraabdominal adhesions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. presence of abdominal adhesion intra operative

    mobile uterus against uterine wall

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study startApr 2019 (estimated)
  3. Primary completionJan 2020 (estimated)
  4. Study completionFeb 2020 (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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03862820
Sponsor's protocol ID
1984
Status last verified
Mar 2019
First submitted
1 Mar 2019
Last updated
12 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstetric Labor Complications, run by Assiut University.

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: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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 Ali Yosef, MD (00201005602284, aliharoun84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of abdominal adhesion intra operative (time frame: 1 year). 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 12 Mar 2019.

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