Clinical trial NCT06023381: Sliding Sign in Late Trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat CS
Official title: Sliding Sign in Third-trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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; 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.

Eligibility criteria: Inclusion Criteria:

1. History of previous cesarean section.
2. Gestational age: Full-Term.
3. Scheduled to undergo elective cesarean section.

Exclusion Criteria:

1. Body mass index more than 40 on admission.
2. Abnormal placental invasion.
3. Having known collagen disease.
4. Unplanned or emergency repeated cesarean delivery.
5. History of abdominal surgery.

Primary outcomes:
measure: The association between a negative sliding sign and severe adhesions
timeFrame: 24 hours
Secondary outcomes:
measure: The association between a negative sliding sign and operative time
timeFrame: 24 hours
measure: hemoglobin drop greater than 3 g/dL
timeFrame: 24 hours
measure: Urinary Bladder injury
timeFrame: 24 hours
measure: Intestinal injury
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain shams University
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Rania Gamal, MD
role: PRINCIPAL_INVESTIGATOR
References: