CTRI/2023/09/057173尚未招募2 期
A COMPARATIVE STUDY OF SAFETY AND EFFICACY OF PROPHYLACTIC INSERTION OF DR.BURKES EVERY SECOND MATTERS UTERINE BALLOON TAMPONADE(ESM-UBT) WITH I.M OXYTOCIN VS ONLY I.M OXYTOCIN FOR PREVENTION OF ATONIC PPH IN WOMEN
Dr D SANTHOSHI1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2023年8月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- To compare the blood loss in women in which Dr Burkes UBTwith I.M oxytocin was used to those in whom only I.M oxytocin is used.
研究概览
简要总结
- The following Study includes Consenting women admitted for delivery in the Department of OBSTETRICS &GYNAECOLOGY in B.L.D.E. (DU) Shri B.M. Patil’s Medical College, Hospital and Research Centre, Vijayapura with the diagnosis of high-risk pregnancy prone for atonic PPH, who fulfill the inclusion criteria
- Group 1-The prophylactic BURKE’S ESM-UBT is applied with 10 units of Oxytocin IM injection for high-risk women prone to atonic PPH.
- Group 2-10 units of Oxytocin IM injection will be given to high-risk women prone to atonic PPH without application of BURKE’S ESM-UBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •Delivering viable babies with high-risk pregnancies who are prone to atonic PPH Grand multipara Hydramnios Pregnancy-induced hypertension Eclampsia Gestational Diabetes mellitus Prolonged labour Abruption Deranged coagulation profile Fibroids Anemia Twin pregnancy.
排除标准
- •Patient with traumatic PPH Adherent or retained placenta Uterine rupture Anomalous uterus Suspected chorioamnionitis Purulent infections in cervix, vagina or uterus.
- •Known advanced cervical cancer.
结局指标
主要结局
To compare the blood loss in women in which Dr Burkes UBTwith I.M oxytocin was used to those in whom only I.M oxytocin is used.
时间窗: Measuring Blood loss immediately after inserting UBT post delivery & 48hrs after delivery
次要结局
- To assess the safety & efficacy of UBT(To study the adverse effects of using UBT)
研究者
研究点 (1)
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