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临床试验/CTRI/2024/07/071389
CTRI/2024/07/071389尚未招募4 期

Comparison of efficacy of Carbetocin versus Oxytocin in the prevention of Postpartum hemorrhage An open label randomized controlled trial

Department of Obstetrics and Gynaecology AIIMS Bathinda1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
114
试验地点
1
主要终点
•To compare incidence of Postpartum hemorrhage by the use of Carbetocin versus oxytocin

研究概览

简要总结

According to American College of Obstetrician and Gynecology, Postpartum hemorrhage is defined as a cumulative blood loss of more than 1000ml with signs and symptoms of hypovolemia within 24 hours of birth process, regardless of route of delivery. Primary PPH is defined as blood loss of more than 500ml after vaginal delivery and more than 1000ml after cesarean section which occurs in first 24 hours after delivery. It constitutes a major cause of maternal morbidity and mortality and complicates approximately 6% of all deliveries. It is the leading cause of maternal mortality and account for 1,25,000 deaths per year worldwide. PPH incidence in India is 2-2.5% of vaginal deliveries, 6% of cesarean section. About 1 woman dies in every 2 minutes, most of these deaths are preventable.

Causes of PPH-

  1. Tone (uterine atony)- 70% cases

  2. Trauma (laceration,rupture)

  3. Tissue (Retained tissue)- causes secondary PPH due to improper uterine retraction

$. Thrombin deficiency (Coagulopathy)

Treatment modalities available for management of PPH-

First line- Medical management- Uterotonics- Inj Oxytocin, Inj Carbetocin, Inj methergine, Tab misoprostol

Uterine tamponade (foley catheter, condom catheter, bakri balloon)

Second line- Surgical management- B lynch sutures, uterine artery ligation, anterior division of internal iliac artery ligation

Arterial embolization

hysterectomy

Oxytocin is frequently used as first choice in cesarean section. Due to its short half life (4-10 minutes), it requires continuous or repeated ad inistration whereas

Carbetocin is a long acting analogue of oxytocin having half life of 40 minutes

Oxytocin is susceptible to heat whereas, Carbetocin is heat stable

There is a paucity of literature regarding comparison of oxytocin and carbetocin, thereforre we plan to conduct a study comp[aring incidence of PPH in postpartum period.

The literature review does not clearly depict the superiority of one study method over other.

Hence, we hypothesize that Carbetocin is equivalent to Oxytocin in prevention of PPH after delivery.

The present hypothesis will be tested using an open label randomized controlled trial (RCT) study design.

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
15.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women at 34 to 40 weeks of gestation undergoing vaginal delivery or cesarean section giving consent to participate.

排除标准

  • 1.Known case of hypersensitivity to oxytocin and carbetocin13 2.Women with coagulation defects 3.Women with medical conditions (pulmonary, hepatic, renal or cardiovascular disease).

结局指标

主要结局

•To compare incidence of Postpartum hemorrhage by the use of Carbetocin versus oxytocin

时间窗: 1.Less than 24 hours of delivery | 2.24 hours to 6 weeks postpartum

次要结局

  • To compare the intrapartum blood loss in carbetocin versus oxytocin group(To compare proportion of women requiring additional uterotonic drugs after administration of carbetocin versus oxytocin)

研究者

发起方
Department of Obstetrics and Gynaecology AIIMS Bathinda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Yukta Dhingra

AIIMS Bathinda

研究点 (1)

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