跳至主要内容
临床试验/CTRI/2025/08/093541
CTRI/2025/08/093541尚未招募不适用

PREDICTION OF INTRAABDOMINAL ADHESIONS IN WOMEN UNDERGOING REPEAT CESAREAN DELIVERY USING CLINICAL FEATURES & ULTRASONOGRAPHIC SLIDING SIGN.

Dr BSA Hospital1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
233
试验地点
1
主要终点
The accuracy of predicting intra-abdominal adhesions (Scar tissue) before surgery using clinical signs and ultrasound sliding sign.

研究概览

简要总结

The fibrous bands formed between organs and abdominal walls are called adhesions. The Intra Abdominal adhesions are common complications following abdominal surgeries, including cesarean deliveries. The intra abdominal adhesions are frequently encountered during repeat cesarean delivery and are aggravated in prevalence and severity in multiple cesarean delivery. Adhesiolysis may result in delayed fetal extraction, injury to adjacent viscera, blood loss and prolonged surgery time. These adhesions can lead later to morbidity like bowel obstructions, infertility, ectopic pregnancy, chronic abdominal and pelvic pain along with dificulty insubsequent surgery.The incidence of adhesions correlates with prior number of cesarean sections. In first cesarean sections the chances of adhesions are 25-46% and increased to 43-75% in second cesarean section and upto 83% in subsequent cesarean section. Riskfactors for adhesions are smoking, history of chronic illness (like diabetes, collagen disease), post-op infection, peritoneal trauma and presence of blood clots following surgery. In contrast, peritoneal and rectus muscle closure are open to debate as a preventive measure against the formation of post cesarean adhesions.The rate of cesarean delivery has increased dramatically in recent years. The rising cesarean section rates can be attributed to rising multiple pregnancy rates, maturing mothers andmedico-legal concerns. Based on data obtained from around 150 countries, the rates of cesarean delivery in diferent regions range from 7.3% to 40.5%. In India, the proportion of cesarean deliveries has increased to 21.5% (2019-21) from just 3% in 1992-93 . Inproportion to these, rates of repeat cesarean section have increased as compared to VBAC. Many women do not consent for TOLAC (trial of labour after cesarean section) and want repeat cesarean section as the family size is limited these days and parents are not willing to take the risk involved. Also, obstetricians are bent towards cesarean delivery due to medico-legal issues.The importance of early detection of adhesions cannot be underestimated as a step towards reducing intraoperative complications. One can plan cesarean in a better manner involving experienced surgeons and can also reduce further adhesion formation by using adequate measures.considering these facts various authors have tried to correlate risk factors inhistory, previous cesarean characteristics, severity of striae, features of abdominal scar andsliding sign on ultrasound to predict presence and severity of intra abdominal adhesion. Striae are linear skin changes in the areas of skin stretching that occur because of dermal damage.it is believed that striae gravidarum, abdominal scar and peritoneal adhesions share similar pathway of healing characteristics. Thus, severity of striae and abdominal scar can be used to predict intra abdominal adhesion. The sensitivity for prediction of intra abdominal adhesions using striae varies from 0.45% to 47.7% whereas specificity varies from 0.89% to 67.6%. Predictive value using striae parameters is ranging from 1.518 to 45 . Prediction using scar features has been studied by several authors but results are not very promising. Also there is a lot of heterogeneity in the studies, sensitivity in predicting intraabdominal adhesions prediction using scar characteristics varies from 0.38 % to 77.35% whereas specificity varies from 0.88% to 58.19%. Predictive value using scar characteristics ranging from 2.405 to 42.

Sliding sign has been used to predict adhesions in women undergoing repeat cesarean with good specificity. In this sliding of the uterus against the abdominal wall is observed. When no movement is observed, the sliding sign is negative. The sonographic sliding sign has been shown to have variable predictive value for the detection of pelvic adhesions in diferent studieswith sensitivity ranging from 53.3 % to 76.2% and specificity ranging from 80.4% to 95%. There have been trials for prediction of intra abdominal adhesions. We wish to assess the role of clinical features and sliding sign in prediction of intra abdominal adhesions in women undergoing repeat cesarean section as this is a very frequent problem and till date there is no method to accurately predict adhesions preoperatively. We will try to correlate risk factors in history, severity of striae, features of abdominal scar and sliding sign on ultrasound to predict presence and severity of intra abdominal adhesions.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Women with gestational age at or beyond 37 weeks with previous cesarean section, planned for repeat cesarean section.

排除标准

  • Women with known collagen disorders.
  • Women with h/o radiation therapy.
  • Placenta Accreta spectrum disorder.

结局指标

主要结局

The accuracy of predicting intra-abdominal adhesions (Scar tissue) before surgery using clinical signs and ultrasound sliding sign.

时间窗: Baseline.

次要结局

  • 1. Longer surgical time.(2. Increased blood loss.)

研究者

发起方
Dr BSA Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Reena Kumari

Dr BSA Medical College and Hospital

研究点 (1)

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