OXYTOCIN VERSUS SYNTOMETRINE VERSUS CARBETOCIN IN CONTROL OF POST PARTUM HEMORRHAGE : AN OPEN LABEL RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- To compare incidence of Postpartum hemorrhage by the use of oxytocin versus
研究概览
简要总结
After a detailed history and physical examination of a pregnant female more than 28 weeks period of gestation and considering inclusion and exclusion critertia, patients will be recruited for the study. A participant information sheet will be given to the patients and after a verbal explanation about the study , written informed consent in patient’s vernacular language will be taken. A case record form will be used for collecting the data. The demographic history, menstrual history, contraceptive history, obstetric history, personal and family history of the participant will be taken A detailed examination of the patient will be done which will include general physical examination, respiratory, cardiovascular, abdominal examination and pelvic examination which will include per speculuim, per vaginum examination, if required. All routine investigations like complete blood count (CBC), Random blood sugar (RBS), urine routine and microscopy (URINE R/M), serum electrolytes (SE), liver function test (LFT), blood group (ABORH), prothrombin tine/international normalized ratio (PT/INR), viral markers, and obstetric ultrasonography if required will be done. 10 Randomisation will be done by using computer generated random number tables. All eligible participants who will give consent for the study will be randomly allocated to group A (receiving oxytocin) or group B (receiving syntometrine) or Group C (receiving carbetocin). Women in group A will receive 10 IU IM injection of oxytocin , women in group B will receive 5 IU of oxytocin +0.5mg of ergometrine (i.e. 1ml of syntometrine) and women in group C will receive 100 micrograms of carbetocin after delivery of baby .The hemoglobin levels of the participant will be compared from the day of admission in labour room to 24 hours after delivery. The following will be taken into account amongst three groups.
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The use of additional uterotonic agents
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Weighed blood loss (by comparing dry weight and weight of pad soaked with blood)
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Duration of third stage of labour
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Transfusion of blood products
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Use of other non-medical measures to treat PPH (like intrauterine balloon tamponade, uterine compression suture) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women with singleton pregnancy of more than 28 weeks of gestation undergoing vaginal delivery or cesarean section and giving consent to participate.
排除标准
- •Women with hypersensitivity or allergy to oxytocin , syntometrine or carbetocin.
- •Women with chronic hypertension, gestational hypertention, pre-eclampsia or ante-partum blood loss of more than 50ml.
- •Women with medical conditions like severe anemia and severe heart disease.
结局指标
主要结局
To compare incidence of Postpartum hemorrhage by the use of oxytocin versus
时间窗: To compare incidence of Postpartum hemorrhage by the use of oxytocin versus | syntometrine versus carbetocin on day of operation and post op day 2 hemoglobin
syntometrine versus carbetocin
时间窗: To compare incidence of Postpartum hemorrhage by the use of oxytocin versus | syntometrine versus carbetocin on day of operation and post op day 2 hemoglobin
次要结局
- • To compare the intrapartum blood loss in oxytocin versus syntometrine versus(carbetocin group.)
研究者
Dr Gagandeep Kaur
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA