Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

赞助:

合作者:

信息的提供 (责任方):

Ahmed Samy aly ashour，Cairo University

追踪信息

首次提交日期 ^ICMJE

September 27, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

November 30, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

incidence of postpartum hemorrhage after CS[ Time Frame: 24 hours ]

Number of participants experienced massive postpartum hemorrhage

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

side effects of drugs used[ Time Frame: 24 hours ]
GIT side effects as nausea , vomiting

描述性信息

简略标题 ^ICMJE

Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

正式标题 ^ICMJE

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery

简要概况

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

详细说明

A double blind randomized study conducted on 400 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (200 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (200 women) after fetal extraction and before placental removal. Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Prevention

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: carbetocin
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Drug: Syntometrine
received combination of 5 IU oxytocin (Syntocinon®, Novartis, Basel, Switzerland) and 0.2 mg ergometrine (Methergin®,Novartis).

研究工具

Experimental: carbetocin
200 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Active Comparator: Syntometrine
200 women received combination of 5 IU oxytocin (Syntocinon®, Novartis, Basel, Switzerland) and 0.2 mg ergometrine (Methergin®,Novartis).

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

400

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 1, 2018

预计主要完成日期

November 30, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - All participants are at 37 - 40 weeks of gestational age - Noncomplicated pregnancy. - obese women with BMI > 30. Exclusion Criteria: - Participants with placenta previa, - coagulopathy, - preeclamptic - known sensitivity to carbetocin,oxytocin or methergine were excluded

性别

参与研究的性别:

Female

年龄

最小年龄：N/A ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Ahmed Samy aly ashour，Cairo University

研究赞助商 ^ICMJE

Cairo University

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: AHMED SAMY, MD Cairo University

PRS 账户

Cairo University

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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