CTRI/2011/091/000045招募中3 期
A Multicentric, Double-blind, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Injection Carbetocin versus Injection Oxytocin in prevention of uterine atony after cesarean section
Precise Chemipharma Pvt Ltd8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- The primary outcome is defined by the need for additional Oxytocic intervention in the 48 hours after delivery to maintain the uterus well contracted, as judged by the investigator, as would be done under usual clinical practice
研究概览
简要总结
This study is A Multicentric, Double-blind, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Injection Carbetocin versus Injection Oxytocin in prevention of uterine atony after cesarean section that will be conducted in three centres in India
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 0.00 Day(s)（—）
- 性别
- Female
入选标准
- •â€¢All subjects with duly filled and signed in ICFs [Informed Consent Forms] •Female patients >18 years of age with confirmed pregnancy reports and planned for cesarean section through a lower-segment transverse incision under regional anesthesia •In generally good health •Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
排除标准
- •â€¢Patients unwilling to sign on ICF •Known hypersensitivity to study drugs •Diagnosed placenta previa or abruptio placentae •Use of general anesthesia •Classic uterine incision for cesarean section •Previous history of uterine atony and postpartum bleeding •Twin gestation •Number of previous cesarean sections •Grand multiparity (>5 previous deliveries).
- •â€¢A current or previous history of significant disease including heart disease •Chronic hypertension requiring treatment •Liver, renal, or endocrine disorders (other than gestational diabetes) •History or currently consuming abusing drugs or alcohol •History of coagulopathy .
- •â€¢Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
- •â€¢Patient’s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-
- •â€¢Patients being treated with any of the excluded medications mentioned in the protocol.
- •â€¢Participation in other trials or Previous participation in this or any other carbetocin clinical trial.
结局指标
主要结局
The primary outcome is defined by the need for additional Oxytocic intervention in the 48 hours after delivery to maintain the uterus well contracted, as judged by the investigator, as would be done under usual clinical practice
时间窗: 48 hours
次要结局
- Position of the fundus and tone of the uterus(48 hours)
研究者
研究点 (8)
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