A double blinded randomized controlled study to assess safety and effectiveness of carbetocin vs oxytocin during active management of third stage, for prevention of PPH in patients undergoing cesarean section
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- TO compare the safety and efficacy of carbetocin with oxytocin to prevent PPH during active management of third stage of labour.
研究概览
简要总结
“ The American College of Obstetricians and Gynecologists (ACOG) defines PPH as blood loss of more than or equal to 1000 ml, or blood loss that was accompanied by signs or symptoms of hypovolemia occurring within 24 h after birth, regardless of the mode of deliveryâ€1
PPH is the leading cause of maternal mortalityÙ°,currently accounting for approximately 25% of pregnancy-associated deaths worldwide.80% of PPH is due to uterine atonicity which is preventable.Active management of the third stage of labor(AMTSL) is done to prevent atonic PPH.This involves the use of interventions (including the use of uterotonics, early clamping of the umbilical cord and controlled cord traction).Uterotonics are oxytocin, methyl ergometrine, carbetocin, carboprost and misoprostol.2
Carbetocin is a heat stable analogue of oxytocin with a longer half life.WHO and FIGO recommends the use of oxytocin (10 IU, IM/IV) for the prevention of PPH for all births.The use of carbetocin (100 μg, IM/IV) is recommended for the prevention of PPH for all births in contexts where its cost is comparable to other effective uterotonics, and also in settings where oxytocin is unavailable (or its quality cannot be guaranteed).1,3
Our study aims to compare the effectiveness of oxytocin vs carbetocin in the active management of the third stage of labor among patients undergoing LSCS in a tertiary care centre by a randomized controlled double blinded study.
240 Antenatal women who are admitted for safe confinement and fulfilling the inclusion and exclusion criteria and giving informed written will be enrolled for the study.
Routine obstetric examination and investigations will be done.
Randomisation will be done by the sealed opaque envelope method.240 randomly generated treatment allocations within sealed opaque envelopes into either group A (OXYTOCIN 10 IU IV) or Group B(Carbetocin 100 mcg IV) will be placed in the OT in a box. In the Operation theater,the Anesthetist will take one of the envelopes and open it and the drug as per the group alloted will be loaded in the syringe.If general anesthesia is required, she will be excluded from the study.Under regional anesthesia, under aseptic precautions , LSCS will be done.
Immediately after the delivery of the baby,AMTSL will be done.Either 100mcg of IV carbetocin slowly over a minute or 10 units of oxytocin slow IV as per the group allotted will be administered.
Once the uterus is well contracted, Uterus will be closed in a single layer with non interlocking sutures using no 1 vicryl.
If uterine atonicity is noted at any point during the intraoperative or postpartum period, additional oxytocics will be given as per need. The doses of these required will be recorded.Surgical methods of control of PPH will be resorted to if required.Any instances of traumatic PPH will be excluded from the study.
Blood loss will be assessed by: A+B-C11
A. The difference in the dry and wet weight of the steripads,mops, packs used.1gm of difference will be considered as 1 ml of blood loss.
B.The volume of the suction bottle.(ml)
C.Amniotic fluid volume in ml.(AFI X 30)
The vitals will be assessed immediately following delivery of the baby and then hourly for 2 hours.
The subject will be assessed for adverse effects of metallic taste, fever, nausea, vomiting, headache, raise/fall in Blood Pressure, shivering, diarrhoea.Any other adverse reactions will be noted.Monitoring will be continued 6 th hourly for the first 24 hrs.
Hb will be reassessed on post operative day 3 and recorded. The difference in the pre op and postoperative Hb will be noted.
Patient will be discharged on post operative day 4 if stable.
The details filled in the proforma will be statistically analyzed to reach a conclusion at the end of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •willing to participate gestational age 36 weeks-41 weeks patients undergoing cesarean section.
排除标准
- •hypertensive pre eclampsia eclampsia ante partum hemorrhage bleeding disorders thrombocytopenia blood coagulation abnormalities cardiovascular disorders epilepsy asthma migraine renal disease liver disease general anesthesia retained placenta placenta accreta placenta previa previous pph grand multipara fibroid with pregnancy prolonged labour hypersensitivity to oxytocin or carbetocin traumatic pph.
结局指标
主要结局
TO compare the safety and efficacy of carbetocin with oxytocin to prevent PPH during active management of third stage of labour.
时间窗: blood loss assesment intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour.
次要结局
- To compare the requirement for additional uterotonics in both groups(need for additional uterotonics assesed intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour.)
- To compare adverse effects among both groups.(adverse effects noted intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour.)
研究者
RAJANI SOMANATHAN
siddaganga medical college and research institute