跳至主要内容
临床试验/CTRI/2026/02/103044
CTRI/2026/02/103044尚未招募不适用

Prevalence and clinical profile of Caesarean Scar Defect after Caesarean Delivery

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2026年2月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
323
试验地点
1
主要终点
Presence or absence of CSD

研究概览

简要总结

Cesarean section rates have been rising significantly over recent years, more so in western world; increasing from 14.5% to 27.2% between the years 2000 and 2017. As per a report by the World Health Organization, roughly 18.5 million women undergo CS annually.The rise in caesarean section deliveries in India also has become a notable public health concern. Rise in the number of deliveries by CS has inevitably resulted in prevalence of its complications, both in short and long term. While C-sections can be lifesaving when medically indicated, their overuse can lead to significant health risks for both mothers and infants, including infections, prolonged recovery times, and increased healthcare costs. One important long term complication is Caesarean Scar defect (CSD) also known as Isthmocoele or Niche.The paucity of Indian research on caesarean scar disorder (CSD) highlights a critical gap in understanding the long-term implications of rising caesarean delivery rates in the country. Despite the increasing incidence of CSD and its associated complications, such as chronic pelvic pain, abnormal bleeding, and infertility, there is a notable lack of focused studies addressing its etiology, diagnosis, and management within the Indian context. This gap is concerning as it limits the ability to formulate effective preventive strategies and treatment protocols tailored to local needs. Furthermore, as caesarean sections become more common, the potential long-term sequelae of CSD—such as uterine rupture or placenta accreta—assume greater significance.  Therefore, there is an urgent need for comprehensive research initiatives in India to investigate the multifactorial aspects of CSD, including surgical techniques, patient demographics, and cultural factors influencing healthcare decisions. Addressing this research deficit will not only improve clinical outcomes but also enhance overall maternal health care in India.The aims of this study is to evaluate the incidence of CSD and CSDi by using standard definitions of both.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Patients delivered by caesarean delivery from Jan 2021 to June 2025 at AIIMS, New Delhi, more than 6 months before the date of recruitment CD done for any indication Patients who have one or more CD.

排除标准

  • Patients with underlying pre-existing uterine pathologies: endometriosis, adenomyosis, fibroid uterus, Mullerian Anomalies Age less than 18 years Patients who have undergone CS less than 6 months ago Women with classical caesarean section History of uterine surgeries Postpartum insertion of an intrauterine contraceptive device (IUCD) Pregnancy at follow up Active genital tract infection at follow-up Refusal to participate in the study.

结局指标

主要结局

Presence or absence of CSD

时间窗: After mor than or equal to 6 months have passed the caesarean section

次要结局

  • Presence or absence of symptoms in CSD(Presence of CSDi)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mehak Aroa

All India Institute of Medical Sciences

研究点 (1)

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