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临床试验/CTRI/2025/09/094824
CTRI/2025/09/094824尚未招募不适用

A longitudinal study to compare the amount of blood loss in caesarean section using QBL ( Quantitative Blood Loss ) v/s Modified Gross Formula

Priyansha Raj1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2025年9月26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
298
试验地点
1
主要终点
To compare the amount of blood loss in caesarean section by QBL (Quantitative Blood Loss) v/s Modified gross formula

研究概览

简要总结

Globally, delivery by caesarean section ranks among the most common obstetric surgical procedures. Obstetric haemorrhage contributes significantly to maternal mortality and morbidity. An essential component of lowering morbidity during C- section is prevention and early recognition of blood loss through an effective means of measurement. The conventional methods of blood loss estimation often results in undiagnosed PPH. Despite, widespread use of haemoglobin and haematoicrit measurements, even in resource limiting settings, their application in estimating blood loss in obstetric care remains underutilize  In order to realize obstetric haemorrhage at an early stage, it is crucial that ongoing blood  loss should be accurately assessed. However, researchers have reported that obstetricians may underestimate blood loss and these underestimations may result in errors in making decisions about giving the patient blood or blood products.The underestimation of blood loss may result in inadequate fluid resuscitation, hypovolemia, shock, organ damage and impaired tissue oxygenation .Several studies conducted have shown a significant correlation between QBL and Modified gross formula in estimation of blood loss in vaginal deliveries. However, not sufficient evidence has been noted for the same in caesarean section, where the amount of blood loss estimated is often considered as a matter of debate due to traditional methods used for assessing the blood loss which lack accuracy.

Data collection procedure

 After approval from the Ethics Committee,patients will be screened for eligibility considering the inclusion and exclusion criteria and those patients who fit according to inclusion criteria will be recruited in the study.

 Complete history will be collected from the medical record files including patient’s obstetric history at the time of admission and patients will be followed up to the date of discharge.

 Pre- and post operative haemoglobin and haematocrit will be recorded

Pre-operative haematocrit being most recent within 1 week of C- section

Post – operative haematocrit will be measured 48 hours after section.

 Blood loss will be calculated using 2 methods –

 1. Conventional methods – This will include the following -

 - Gravimetric method- a Brasss V drape will be placed under buttocks of patient before starting the caesarean section and the amount of blood collected in the drape at the end of C- section will be recorded

 - Suction canister – the process of quantification of blood loss will begin after the amniotic membrane is ruptured and baby is born. First suctioning of all the amniotic fluid will be done in one suction canister till the delivery of placenta.

After delivery of placenta blood will be suctioned in a different suction canister

  • Soaked pads and gauze – weight of dry gauze and pads will be recorded. After section the weight of soaked pads and gauzes will be recorded where 1 gm weight will be taken as 1 ml of blood loss and the difference between the two weights would give an estimate of amount of blood loss

All these will be added to get the amount of blood loss by conventional method

2.     Modified gross formula –

 - Haemoglobin and haematocrit values will be recorded prior to section and then repeated again after 48 hours of surgery

  • Amount of blood loss will be calculated using this formula –

  • Blood loss - Estimated BV X ( Hct pre-op – Hct post-op ) / Hct average

 Where estimated blood volume will be taken as 70ml/kg

 Blood loss estimation by both the methods will be compared

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Women with term gestation undergoing caesarean section at KLEs Prabhakar Kore Charitable Hospital and MRC Belagavi.

排除标准

  • Women undergoing preterm caesarean section
  • Women with severe anaemia
  • History of anticoagulant usage
  • History of aspirin usage
  • Patients receiving blood transfusion within 48hours of section
  • Patients with severe pre-eclampsia and eclampsia
  • History of bleeding disorders.

结局指标

主要结局

To compare the amount of blood loss in caesarean section by QBL (Quantitative Blood Loss) v/s Modified gross formula

时间窗: Term gestation ( 37 weeks - 40weeks period of gestation )

次要结局

未报告次要终点

研究者

发起方
Priyansha Raj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Priyansha Raj

Jawaharlal Nehru medical College , KLE university Belagavi

研究点 (1)

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