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临床试验/CTRI/2024/05/067623
CTRI/2024/05/067623尚未招募2 期

The efficacy of Intravenous Carbetocin versus Intravenous Oxytocin in active management of Third stage of labour in women delivering vaginally - A randomised controlled trial

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
184
试验地点
1
主要终点
1. Quantitative measure of blood loss during the third stage of labor.

研究概览

简要总结

Introduction: Active management of the third stage of labor (AMTSL) is a critical intervention for Postpartum hemorrhage (PPH) prevention which is commonly caused by uterine atony. The current standard therapy for the prevention of PPH is oxytocin but it presents unsatisfactory real-world efficacy because of its sensitivity to heat and insufficient active ingredients or impurities, however, an oxytocin analog heat-stable carbetocin  does not require cold-chain transport and storage. Therefore, this study aims to determine the efficacy of Intravenous (IV) carbetocin in the AMTSL in vaginal deliveries.

Methodology: A total of 184 antenatal women will be randomized by computer-generated randomization and a sequentially numbered, sealed opaque envelope method will be used for allocation in this single-blinded parallel-group randomized controlled trial. Group A (study group) will receive an injection of carbetocin 100 mcg IV slow bolus as a single dose and Group B (control group) will receive 10 IU IV infusion of oxytocin after the delivery of the baby within 1 minute and before the delivery of the placenta.

Result: The blood loss in each group will be calculated using a quantitative method of measuring blood loss. The use of other uterotonics to prevent PPH will be taken into account. The patient’s hemoglobin and need for blood transfusion will be noted on day 3 following the vaginal delivery. The statistical analysis will include descriptive and inferential analysis to determine the significant difference.

Conclusion: The present study will be comparing and concluding the efficacy of IV carbetocin with IV oxytocin in the AMTSL and PPH in vaginal deliveries. This will explore the implication of a much more effective drug that will assist in the prevention of PPH and reduce mortality and morbidity during vaginal deliveries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

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 a singleton-term pregnancy undergoing vaginal delivery.

排除标准

  • Hypertensive disorders in pregnancy
  • Moderate anemia (Hemoglobin less than 9gm per dl)
  • Placental abruption (determined by history and ultrasound report)
  • Placenta previa
  • Polyhydramnios
  • Grand Multipara
  • Known case of cardiac disease.

结局指标

主要结局

1. Quantitative measure of blood loss during the third stage of labor.

时间窗: Immediately post delivery and on day 3 post delivery.

2. Hemoglobin level

时间窗: Immediately post delivery and on day 3 post delivery.

次要结局

  • Not applicable(Not applicable)

研究者

发起方
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Nidhi Kaushal Shah

Department of Obstetrics and Gynaecology

研究点 (1)

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