Intra-Abdominal; AdhesionNCT03800511
Prediction of Intra-abdominal Adhesion Before CS
An observational study of Intra-Abdominal; Adhesion, run by Nahed allam.
Trial summary
Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Intra-Abdominal; Adhesion
- What is being tested?
- sliding test
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Aug 2019
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women in their 9th-month singleton planned for elective repeated CS and had a history of previous CS
Who may be able to join
- pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS
Who cannot join
- included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prediction of Intra-abdominal Adhesion Before CS: A Diagnostic Test Study
Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.
Read the detailed description
the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.
- Conditions
- Intra-Abdominal; Adhesion
- Being tested
- sliding test
- Keywords
- sliding test , ceaserean section
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sliding testDiagnostic test
Also called ultrasound detected sliding test
ultrasound detected sliding test before doing repeated caesarean section
| Study group | Role | What they receive |
|---|---|---|
| repeated caesarean section | full term pregnant women with singleton baby with a history of at least previous one caesarean section Receives: Diagnostic Test: sliding test |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-abdominal adhesion
presence of adhesion between uterus and abdominal wall or intestine on bladder
Measured: intra-operative period
Secondary outcomes (2)
skin to uterine incision time
time consumed by surgeon from skin incision to uterine incision in minutes
Measured: intra-operative period
need to insert intra-peritoneal drain
if there in marked adhesion and vascular injury a drain could be inserted
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal; AdhesionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahed allam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nahed allam, Al-Azhar University
- Investigators
- Taiseer Maarouf, MD, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800511
- Sponsor's protocol ID
- Prediction of intra-abdominal
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.discussion with the other authors after completion of recruitment of patients
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Intra-abdominal Adhesion Before CS: A Diagnostic Test Study
- ClinicalTrials.gov ID
- NCT03800511
- Acronym / sponsor ID
- Prediction of intra-abdominal
- Conditions
- Intra-Abdominal; Adhesion
- Keywords
- sliding test , ceaserean section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Nahed allamUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 11 Jan 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.
Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.
Detailed description
the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repeated caesarean section | – | Diagnostic Test: sliding testfull term pregnant women with singleton baby with a history of at least previous one caesarean section |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women in their 9th-month singleton planned for elective repeated CS and had a history of previous CS
Key inclusion criteria (1 listed)
- pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS
Key exclusion criteria (1 listed)
- included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS
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 |
|---|---|---|
| sliding testAlso: ultrasound detected sliding testultrasound detected sliding test before doing repeated caesarean section | Diagnostic test | repeated caesarean section |
Primary outcome
intra-abdominal adhesion
Time frame: intra-operative period
presence of adhesion between uterus and abdominal wall or intestine on bladder
2 secondary outcomes
skin to uterine incision time
Time frame: intra-operative period
need to insert intra-peritoneal drain
Time frame: intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.discussion with the other authors after completion of recruitment of patients
Related trials for Intra-Abdominal; Adhesion
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Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
Adhesive Peritoneal Band
RecruitingObservational study
Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions
Tissue Adhesions
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.
Taiseer Maarouf, MD study chair
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal; Adhesion, run by Nahed allam.
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 14 Jan 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 nahed allam, MD (+0201121116136, nahedallam16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-abdominal adhesion (time frame: intra-operative period). 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 Jan 2019.