Cesarean Section ComplicationsNCT06023381
Sliding Sign in Late Trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat CS
An observational study of Cesarean Section Complications, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Predicting the presence of severe adhesions may also assist clinically in several ways: first, it allows allocation of more complicated surgeries to experienced surgeons; second, the surgeons can plan and prepare better for the surgery if they know in advance whether they are going to operate a complicated surgery… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Sliding sign
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Jul 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All third trimester pregnant women with a history of previous cesarean section who were admitted for elective caesarian section had Transabdominal Ultra-sound during the preoperative examination, using the real-time Transabdominal ultrasound pelvic features
Who may be able to join
- History of previous cesarean section.
- Gestational age: Full-Term.
- Scheduled to undergo elective cesarean section.
Who cannot join
- Body mass index more than 40 on admission.
- Abnormal placental invasion.
- Having known collagen disease.
- Unplanned or emergency repeated cesarean delivery.
- History of abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sliding Sign in Third-trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat Cesarean Section
Predicting the presence of severe adhesions may also assist clinically in several ways: first, it allows allocation of more complicated surgeries to experienced surgeons; second, the surgeons can plan and prepare better for the surgery if they know in advance whether they are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be performed in an experienced center, preparing cross match blood units, and alerting the general surgeon and urologist of the potential risk for surgical complications, saving time if intervention is required.
This information can permit preoperative planning by a multidisciplinary team of surgeons and allow the patient to be informed of the potentially high risk of complications.
Read the detailed description
The incidence of repeat cesarean delivery is on the rise worldwide, approximately 90% of women with a prior cesarean delivery undergo a planned repeat cesarean delivery in their next pregnancy.
Post-cesarean adhesions are a major complication in subsequent surgeries, causing an increased risk for bladder and bowel injury (0.1-0.3%), hemorrhage (0.1-1.4%), infection (0.4-1.6%), and even hysterectomy (0.1-1.4%).
In addition to the risk associated with the pelviabdominal surgical procedure itself, adhesiolysis may result in injury to adjacent viscera, blood loss, and in case of emergency cesarean delivery, to the perinatal adverse outcome associated with delayed delivery of the neonate. This represents a considerable healthcare issue, as it has a significant impact both on the patient, increasing morbidity and mortality, and on healthcare costs. It is therefore important for surgeons to detect patients at high risk of having adhesions.
Women suspected to have severe intra-abdominal adhesions may benefit from appropriate preparation of blood products, better assignment of surgeons, request for preoperative surgical assistance of other medical specialties, and possibly performance of a midline skin incision to enter the peritoneal cavity. It is therefore important for surgeons to detect patients at high risk of having adhesions.
Various means have been proposed to predict adhesions prior to surgery, including analysis of patient characteristics and appearance of the scar, as well as the intraoperative peritoneal adhesion index.
- Conditions
- Cesarean Section Complications
- Being tested
- Sliding sign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sliding signOther
All women had Transabdominal Ultra-sonography using SAMSUNG WS80 "elite" ultrasound machine during the preoperative examination, using the real-time Transabdominal pelvic features (the relative motion between the maternal abdominal and uterine wall).
The patient was asked to breathe deeply, accentuating her respiratory movements and the sonographer recorded a video clip in a mid-sagittal plane lateral to umbilicus focus on the infra-umbilical space, to determine whether the structure glided freely in relation to adjacent structures. To be considered as sliding, the structures had to glide easily, one against the other (positive sliding sign); no motion of the structure in question signaled a negative sliding sign.
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between a negative sliding sign and severe adhesions
through transabdominal ultrasound
Measured: 24 hours
Secondary outcomes (4)
The association between a negative sliding sign and operative time
time from skin incision to delivery of the baby
Measured: 24 hours
hemoglobin drop greater than 3 g/dL
calculated between preoperative and postoperative hemoglobin levels
Measured: 24 hours
Urinary Bladder injury
intraoperative diagnosis or postoperatively
Measured: 24 hours
Intestinal injury
intraoperative diagnosis or postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Oct 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Al Shirbiny Hamed Esmail, Ain Shams Maternity Hospital
- Investigators
- Rania Gamal, MD, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023381
- Sponsor's protocol ID
- Sliding Sign
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sliding Sign in Third-trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat Cesarean Section
- ClinicalTrials.gov ID
- NCT06023381
- Acronym / sponsor ID
- Sliding Sign
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 5 Sep 2023 (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.
Predicting the presence of severe adhesions may also assist clinically in several ways: first, it allows allocation of more complicated surgeries to experienced surgeons; second, the surgeons can plan and prepare better for the surgery if they know in advance whether they are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be performed in an experienced center, preparing cross match blood units, and alerting the general surgeon and urologist of the potential risk for surgical complications, saving time if intervention is required.
This information can permit preoperative planning by a multidisciplinary team of surgeons and allow the patient to be informed of the potentially high risk of complications.
Detailed description
The incidence of repeat cesarean delivery is on the rise worldwide, approximately 90% of women with a prior cesarean delivery undergo a planned repeat cesarean delivery in their next pregnancy.
Post-cesarean adhesions are a major complication in subsequent surgeries, causing an increased risk for bladder and bowel injury (0.1-0.3%), hemorrhage (0.1-1.4%), infection (0.4-1.6%), and even hysterectomy (0.1-1.4%).
In addition to the risk associated with the pelviabdominal surgical procedure itself, adhesiolysis may result in injury to adjacent viscera, blood loss, and in case of emergency cesarean delivery, to the perinatal adverse outcome associated with delayed delivery of the neonate. This represents a considerable healthcare issue, as it has a significant impact both on the patient, increasing morbidity and mortality, and on healthcare costs. It is therefore important for surgeons to detect patients at high risk of having adhesions.
Women suspected to have severe intra-abdominal adhesions may benefit from appropriate preparation of blood products, better assignment of surgeons, request for preoperative surgical assistance of other medical specialties, and possibly performance of a midline skin incision to enter the peritoneal cavity. It is therefore important for surgeons to detect patients at high risk of having adhesions.
Various means have been proposed to predict adhesions prior to surgery, including analysis of patient characteristics and appearance of the scar, as well as the intraoperative peritoneal adhesion index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All third trimester pregnant women with a history of previous cesarean section who were admitted for elective caesarian section had Transabdominal Ultra-sound during the preoperative examination, using the real-time Transabdominal ultrasound pelvic features
Key inclusion criteria (3 listed)
- History of previous cesarean section.
- Gestational age: Full-Term.
- Scheduled to undergo elective cesarean section.
Key exclusion criteria (5 listed)
- Body mass index more than 40 on admission.
- Abnormal placental invasion.
- Having known collagen disease.
- Unplanned or emergency repeated cesarean delivery.
- History of abdominal surgery.
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 signAll women had Transabdominal Ultra-sonography using SAMSUNG WS80 "elite" ultrasound machine during the preoperative examination, using the real-time Transabdominal pelvic features (the relative motion between the maternal abdominal and uterine wall). The patient was asked to breathe deeply, accentuating her respiratory movements and the sonographer recorded a video clip in a mid-sagittal plane lateral to umbilicus focus on the infra-umbilical space, to determine whether the structure glided freely in relation to adjacent structures. To be considered as sliding, the structures had to glide easily, one against the other (positive sliding sign); no motion of the structure in question signaled a negative sliding sign. | Other | – |
Primary outcome
The association between a negative sliding sign and severe adhesions
Time frame: 24 hours
through transabdominal ultrasound
4 secondary outcomes
The association between a negative sliding sign and operative time
Time frame: 24 hours
hemoglobin drop greater than 3 g/dL
Time frame: 24 hours
Urinary Bladder injury
Time frame: 24 hours
Intestinal injury
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Rania Gamal, MD principal investigator
Ain Shams Maternity Hospital
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 Section Complications, run by Ain Shams Maternity Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between a negative sliding sign and severe adhesions (time frame: 24 hours). 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 5 Sep 2023.