Novel technique to control PPH and conserve the uterus is cases of Placenta Accreta Spectrum (PAS) disorder - A prospective interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of PPH after surgical intervention
研究概览
简要总结
Protocol Summary – PAS001
Title
A Multicentric Open Label Prospective Interventional Study to Evaluate the Efficacy of a Novel Surgical Technique to Control PPH and Conserve the Uterus in Cases of Placenta Accreta Spectrum PAS Disorder
Protocol ID PAS001
Study Design Prospective multicenter open label interventional study
Study Sites
Pushpam Hospital Sabarmati Ahmedabad
Pushpam Upvan Prasutigurh Tragad Ahmedabad
Matis Multispeciality Hospital Motera Ahmedabad
Investigators
Dr Mahesh Gupta Dr Rutul Kapadia Dr Usha Gupta
Background and Rationale
Placenta Accreta Spectrum PAS disorders are rising due to increasing cesarean deliveries. Conventional management often involves peripartum hysterectomy resulting in high maternal morbidity and loss of fertility. To address this the study proposes a novel conservative surgical technique aimed at controlling postpartum hemorrhage PPH and preserving the uterus in PAS cases.
Aim
To evaluate the efficacy of a novel surgical technique in reducing maternal morbidity and mortality by preventing PPH and avoiding hysterectomy in PAS disorders.
Objectives
Primary Objectives
Prevent PPH in PAS cases
Conserve the uterus during surgical management
Secondary Objectives
Quantify intraoperative blood loss
Assess maternal and fetal outcomes
Study Population
20 pregnant women aged 18 to 45 years with antenatal or intraoperative diagnosis of PAS meeting inclusion criteria will be enrolled from the three study sites over one year.
Methodology Overview
Participants undergoing cesarean delivery will be assessed using a structured surgical approach that includes uterine exteriorization with placenta in situ application of a uterine tourniquet Foleys catheter stepwise arterial ligation and tailored myometrial suturing to achieve hemostasis. Intraoperative blood loss will be measured and postoperative recovery will be monitored.
Key Outcomes
Primary Outcomes
Rate of uterine preservation
Incidence of PPH requiring hysterectomy
Secondary Outcomes
Volume of intraoperative blood loss
Maternal complications
Fetal outcomes Apgar score NICU admission
Significance
This study introduces a potentially safer uterus sparing surgical technique for PAS cases. If effective it may serve as a practical alternative to radical hysterectomy preserving fertility and reducing maternal risk.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age Criteria: Female of Child bearing age group from 18 years to 45 years
- •Patients with antenatal diagnosis of Placenta Previa
- •Patients with antenatal diagnosis or suspected case of PAS disorder
- •Patients with intra operative diagnosis of PAS disorder.
排除标准
- •Patient with Blood coagulopathy.
结局指标
主要结局
Incidence of PPH after surgical intervention
时间窗: 1 day
次要结局
- Feto-Maternal outcome(7 days)
- Rate of Cesarean Hysterectomy
- Estimation of blood loss during intervention(1 day)
研究者
Dr Mahesh Gupta
Pushpam Upvan Prasutigurh