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

September 1, 2023 updated by: Mahmoud Al Shirbiny Hamed Esmail, Ain Shams Maternity Hospital

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between a negative sliding sign and severe adhesions
Time Frame: 24 hours
through transabdominal ultrasound
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between a negative sliding sign and operative time
Time Frame: 24 hours
time from skin incision to delivery of the baby
24 hours
hemoglobin drop greater than 3 g/dL
Time Frame: 24 hours
calculated between preoperative and postoperative hemoglobin levels
24 hours
Urinary Bladder injury
Time Frame: 24 hours
intraoperative diagnosis or postoperatively
24 hours
Intestinal injury
Time Frame: 24 hours
intraoperative diagnosis or postoperatively
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rania Gamal, MD, Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sliding Sign

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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