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Completed

NCT Number: NCT06023381

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

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.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine, Ain shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The association between a negative sliding sign and severe adhesions

    Time frame: 24 hours

    through transabdominal ultrasound

Secondary outcomes

  1. The association between a negative sliding sign and operative time

    Time frame: 24 hours

    time from skin incision to delivery of the baby

  2. hemoglobin drop greater than 3 g/dL

    Time frame: 24 hours

    calculated between preoperative and postoperative hemoglobin levels

  3. Urinary Bladder injury

    Time frame: 24 hours

    intraoperative diagnosis or postoperatively

  4. Intestinal injury

    Time frame: 24 hours

    intraoperative diagnosis or postoperatively

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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