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

NCT06023381 | Completed DMC

• 1 other identifier: Sliding Sign
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• The association between a negative sliding sign and severe adhesions

  through transabdominal ultrasound

  24 hours

Secondary Outcomes (4)

• The association between a negative sliding sign and operative time

  24 hours

• hemoglobin drop greater than 3 g/dL

  24 hours

• Urinary Bladder injury

  24 hours

• Intestinal injury

  24 hours

Interventions

Sliding sign OTHER

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Faculty of Medicine, Ain shams University

Cairo, Egypt

Location

Study Officials

• Rania Gamal, MD

  Ain Shams Maternity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)