A Comparative Study Of Chitosan Covered Gauze With Intramuscular Oxytocin Versus Intramuscular Oxytocin For Prevention Of Atonic Postpartum Hemorrhage In Women With Risk Of Uterine Atony.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the blood loss during vaginal delivery when Chitosan coated gauze for prevention of of postpartum haemorrhage is used along with IM oxytocin in comparision to IM oxytocin alone
研究概览
简要总结
Uterine packing with a chitosan-covered tamponade is an emerging tool in the armamentarium of the obstetrical team, especially when resources for advance surgical and other invasive options may be limited and in pregnant women with risk of uterine atony.
Patients will be selected for the study based on inclusion and exclusion criteria and randomised into two groups.
• Group 1-The Chitosan coated gauze is packed within uterus after vaginal dlivery along with administration of 10 units of oxytocin Intramuscular injection given within one minute of delivery for high-risk women prone to PPH.
• Group 2- 10 units of oxytocin Intramuscular injection will be given to high-risk women prone to PPH .
The amount of blood loss in PPH with and without application of uterine chitosan gauze in high-risk women is measured using brass vaginal drapes, weighing wet gauzes and clots. (1gm=1mL)
Any other additional intervention or information, pharmacological or surgical are noted. Pre delivery and post delivery(after 72 hours ) Hemoglobin shall be recorded and difference noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 Postpartum haemorrhage.
- •Maternal age of more than 18 years Grand multipara Hydramnios Hypertensive disorders of pregnancy Eclampsia Gestational Diabetes Mellitus Abruption Anemia Multiple gestation Prolonged labour.
排除标准
- •The use of Chitosan gauze only for vaginal lacerations.
- •Patients undergoing caesarean section.
- •Patients with Traumatic PPH.
- •Adherant or retained placenta.
- •Anamolous uterus.
- •Suspected chorioamniotis.
结局指标
主要结局
To evaluate the blood loss during vaginal delivery when Chitosan coated gauze for prevention of of postpartum haemorrhage is used along with IM oxytocin in comparision to IM oxytocin alone
时间窗: The amount of blood loss in PPH with and without application of uterine chitosan gauze in high-risk women is measured using brass vaginal drapes, weighing wet gauzes and clots. (1gm=1mL) | Any other additional intervention or information, pharmacological or surgical are noted. Pre delivery and post delivery(after 72 hours ) Hemoglobin shall be recorded and difference noted.
次要结局
- To assess the need for additional uterotonic drugs.(To assess the need for surgical intervention)
- To asses the need for additional uterotonic drugs.(To assess the need for surgical intervention.)
研究者
Dr Nikita Arali
Shri B M Patil Deemed To Be University.