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临床试验/CTRI/2025/12/098824
CTRI/2025/12/098824尚未招募不适用

Effect of preoperative warming of parturients on blood loss during Cesarean section under spinal anesthesia: A Randomized Controlled Trial {HeAT-PS Hemorrhage Assessment after Thermoregulation in Parturient under Spinal anesthesia.}

NOT APPLICABLE1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年12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
132
试验地点
1
主要终点
To compare the amount of intraoperative blood loss between the two groups.

研究概览

简要总结

Summary This randomized controlled trial investigates the impact of preoperative warming on blood loss during cesarean section under spinal anesthesia. Cesarean sections are increasingly common, with maternal hemorrhage a leading cause of morbidity and mortality in India, particularly among anemic parturients. Spinal anesthesia often causes vasodilation and hypothermia, exacerbating bleeding risks. Preoperative warming has shown promise in minimizing these effects by maintaining normothermia and improving coagulation.

The study hypothesizes that active prewarming can reduce intraoperative blood loss, enhance thermal comfort, reduce shivering, and improve maternal and neonatal outcomes. A total of 132 participants scheduled for elective cesarean sections under spinal anesthesia will be enrolled at AIIMS Nagpur. They will be randomly assigned to two groups: the Control Group (C), which will receive standard care without active warming, and the Prewarming Group (P), which will receive 20 minutes of forced-air warming and warm IV fluids.

The primary objective is to compare intraoperative blood loss between the groups. Secondary objectives include evaluating the incidence of hypothermia and shivering, assessing maternal thermal comfort, and measuring neonatal outcomes (umbilical blood gas values and Apgar scores at 1 and 5 minutes). Blood loss will be quantified using suction volumes, blood-soaked materials, and postoperative hemoglobin changes. Core temperature will be monitored at multiple time points, and thermal comfort and shivering will be graded using established scales.

The study duration is 16 months, with ethical and CTRI approvals obtained prior to initiation. Data will be analyzed using SPSS software, applying appropriate statistical tests. This research aims to demonstrate that preoperative warming is a simple, feasible intervention that can significantly improve safety and outcomes for parturients undergoing cesarean sections under spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • All patients scheduled for elective cesarean section under spinal anesthesia.

排除标准

  • 1.Contradiction to spinal anesthesia 2.Twin pregnancy 3.Placenta previa 4.Placenta accreta 5.Gestational hypertension/ pre-eclampsia 6.History of previous cesarean section 7.Conversion to general anesthesia 8.Coagulation disorders 9.Abruptio placenta 10.Polyhydramnios 11.Patients not giving consent.

结局指标

主要结局

To compare the amount of intraoperative blood loss between the two groups.

时间窗: intraoperative period

次要结局

  • To compare incidence of hypothermia core temperature less than 36 degree celsius and shivering between two groups.(T0 = baseline, T1 = pre-spinal, T2 = post-spinal, T3 = after 15 min in the OR, T4 =after 30min in the OR, T5 =surgery end, T6 = PACU arrival, T7 = after 30 min in the PACU, T8 = at discharge from the OR)
  • To compare patient comfort using verbal numerical scale.
  • To compare the neonatal outcomes (umbilical blood gas analysis and Apgar score at 1 and 5 min)(1 minute and 5 minutes of life)
  • 4. uterine tone(intraoperative period)

研究者

申办方类型
Other [No monetary support will be needed]
责任方
Principal Investigator
主要研究者

Rapaka Lasyapriya Sivprasad

AIIMS Nagpur

研究点 (1)

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