Obstetric Labor ComplicationsNCT03862820
Dynamic Ultrasound for Prediction of Adhesion Section
An observational study of Obstetric Labor Complications, run by Assiut University.
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
- To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
- 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
- To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
- 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.
- Conditions
- Obstetric Labor Complications
- 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.
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.
- First posted5 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Haroun YOSEF, Assiut University
- Investigators
- Ali Yosef, Principal investigator, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dynamic Ultrasound for Prediction of Adhesions in Women Undergoing Repeated Cesarean Section, an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03862820
- Acronym / sponsor ID
- 1984
- Conditions
- Obstetric Labor Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 5 Mar 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.
- To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
- To detect the interobserver and intraobserver reliability of this method
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
- To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women planned for elective repeated section
Key inclusion criteria (1 listed)
- Pregnant women in third trimester planned to undergo elective cesarean section
Key exclusion criteria (1 listed)
- Primary elective cesarean section.
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 |
|---|---|---|
| dynamic ultrasoundmove abdomen with ultrasound probe to predict intraabdominal adhesions | Diagnostic test | – |
Primary outcome
presence of abdominal adhesion intra operative
Time frame: 1 year
mobile uterus against uterine wall
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Ali Yosef principal investigator
Assiut University
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.