跳至主要内容
临床试验/CTRI/2023/09/057333
CTRI/2023/09/057333招募中4 期

Comparative study of Carbetocin vs Oxytocin in the prevention of post partum haemorrhage following vaginal delivery

Ramaiah medical college1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2023年10月9日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
116
试验地点
1
主要终点
The aim of the study is to compare the effects of carbetocin with those of oxytocin in several dosing regimens for the prevention of uterine atony in patients undergoing full term vaginal delivery. The outcome is assessed in terms of blood loss, need for additional uterotonic agents, fall in blood pressure, side effects of the drug Carbetocin if any

研究概览

简要总结

The study includes all women who have delivered vaginally . Quantification of blood loss is done by making a list of  dry weights for delivery items that may become blood soaked with directions on how to calculate blood loss.  Quantification of blood loss is begun immediately after the infant’s birth (before delivery of the placenta) and  the amount of fluid collected in a calibrated under-buttocks drape is assessed and recorded. Most of the fluid collected before delivery of the placenta is amniotic fluid, urine, and feces. If irrigation is used, the amount of irrigation from the total fluid that was collected is subtracted. The total volume of fluid collected in the under-buttocks drape is recorded. The preplacental fluid volume is subtracted from the post placental fluid volume to more accurately determine the actual blood loss. Most of the fluid collected after the delivery of the placenta is blood. The fluid volume collected in the drapes is added to the blood volume measured by weighing soaked items to determine the cumulative volume of blood loss or quantification of blood loss. All blood-soaked materials and clots are weighed to determine cumulative volume. 1 gram weight=1 milliliter blood loss volume. The equation* used when calculating blood loss of a blood-soaked item is WET Item Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item.. [10, 11, 12]

Randomized controlled trials with outcome measure of blood loss ≥500ml are eligible if they compared carbetocin with oxytocin to prevent postpartum hemorrhage during prophylaxis of PPH in women following vaginal delivery. The primary outcome is blood loss of at least 500ml after vaginal delivery. The secondary outcomes will be blood loss of at least 1000ml; use of additional uterotonic agents; blood transfusion; uterine massage; flushing; vomiting; abdominal pain; nausea; dizziness; headache; palpitation; itching; shivering.

Side-effects are also an important concern when choosing uterotonic agents. Although carbetocin seems to be an ideal agent compared to other uterotonic agents, some side-effects, such as vomiting, nausea, and dysarteriotony, are still concerning. Side-effects are also considered as secondary outcomes in these trials. Clinicians do not fully understand the side-effects of carbetocin to PPH, particularly the unanticipated ones. There seems to be a gap in the detailed presentation of the side-effects of carbetocin. Therefore, this study also aims to assess the side-effects of  carbetocin compared to oxytocin in the prevention of PPH

Carbetocin 100mcg IV will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered oxytocin 10IU with additional uterotonic agents.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • (1) at or beyond 28 gestational weeks; (2) 18–45 years old; (2) at least one risk factor for developing atony.

排除标准

  • Participants with cardiovascular disorders, hepatic or renal disease, epilepsy, known allergies to oxytocin or carbetocin.

结局指标

主要结局

The aim of the study is to compare the effects of carbetocin with those of oxytocin in several dosing regimens for the prevention of uterine atony in patients undergoing full term vaginal delivery. The outcome is assessed in terms of blood loss, need for additional uterotonic agents, fall in blood pressure, side effects of the drug Carbetocin if any

时间窗: Outcome is assessed immediately after delivery and 12 hours, 24 hours after delivery.

次要结局

  • This study is aimed at comparing the effects of carbetocin vs oxytocin in prevention of postpartum hemorrhage following vaginal delivery in terms of:(Secondary outcomes -)

研究者

申办方类型
Private medical college

研究点 (1)

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