Sliding Sign in Late Trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat CS

Cesarean Section Complications Clinical Trial

Official title:

Sliding Sign in Third-trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06023381
• Other study ID #: Sliding Sign
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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; 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Tissue Adhesions

Intervention

Other:
• Sliding sign
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between a negative sliding sign and severe adhesions	through transabdominal ultrasound	24 hours
Secondary	The association between a negative sliding sign and operative time	time from skin incision to delivery of the baby	24 hours
Secondary	hemoglobin drop greater than 3 g/dL	calculated between preoperative and postoperative hemoglobin levels	24 hours
Secondary	Urinary Bladder injury	intraoperative diagnosis or postoperatively	24 hours
Secondary	Intestinal injury	intraoperative diagnosis or postoperatively	24 hours