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 Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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).
- •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 .
- •Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
- •Patientâ??s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.
- •Patients being treated with any of the excluded medications mentioned in the protocol.
- •Participation in other trials or Previous participation in this or any other carbetocin clinical trial
研究者
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