TO STUDY THE EFFECT OF MATERNAL BLOOD PRESSURE CHANGES DURING SPINAL ANAESTHESIA IN PATIENTS UNDERGOING ELECTIVE CESAREAN SECTION, ON SHORT TERM NEONATAL OUTCOMES.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The effect of maternal blood pressure change no hypotension less than 20 per cent from baseline ,mild 20 to 30 percent from baseline and moderate 30 to 40 percent fall from baseline , Severe more than 40 percent from baseline, during Spinal Anaesthesia on the neonate is assessed by the umbilical artery cord blood pH and base deficit , Apgar score of the neonate at 1min, 5 mins and 10mins & the need for nursery admission . The Fetal acidosis is considered as umbilical arterial cord blood pH of less than 7.2.The ABG has to be analysed within 30 minutes . With these datas we can conclude the primary objective of whether this affects the neonatal outcomes or not.
研究概览
简要总结
Hypotension is the commonest complication of spinal anaesthesia . This hypotension in parturients undergoing elective cesarean section under spinal anaesthesia is associated with reduced uteroplacental perfusion , if not treated immediately can lead to neonatal acidemia .But the term neonates tolerated this acidosis . The incidence of hypotension under spinal anaesthesia was more than 50% . It was found that those parturients who hypotensed (58.2%) had 9.2% babies with acidosis and those who were normotensive (41.8%) had 0.5% babies with acidosis. Since there were very few prospective studies and few indian studies on this topic , i would like to observe the change in the hypotension (<20% - normotensive , 20-30%-mild hypotensive, 30-40%-moderate hypotensive, >40% severe hypotension) ,and their efffect on the neonate which is measured using three parameters- umbilical cord blood ABG, Apgar scores at 1 minute, 5 minutes, 10 minutes, the rate of nursery admission decided by neonatalogist. Other factors causing neonatal acidosis like Anaesthesia -incision-delivery time and boluses of ephedrine will be observed as secondary objective. Hence , the main purpose of my study is to observe ,whether the changes in the maternal blood pressure under spinal anaesthesia in parturients undergoing elective cesarean section has any effect on short term neonatal outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- •All parturients at term gestational age with no antenatal risk factors undergoing elective caesarean section planned under Spinal anaesthesia and their neonates .
排除标准
- •1.Not willing to participate in the study. 2.Emergency LSCS 3.Antenatal risk factors –PIH, preeclampsia, eclampsia, GDM ,APH . Multiple pregnancy. 4.Fetal risk factors like.
- •Any history of IUGR, Congenital Anomalies, Short for gestational age for this baby.
结局指标
主要结局
The effect of maternal blood pressure change no hypotension less than 20 per cent from baseline ,mild 20 to 30 percent from baseline and moderate 30 to 40 percent fall from baseline , Severe more than 40 percent from baseline, during Spinal Anaesthesia on the neonate is assessed by the umbilical artery cord blood pH and base deficit , Apgar score of the neonate at 1min, 5 mins and 10mins & the need for nursery admission . The Fetal acidosis is considered as umbilical arterial cord blood pH of less than 7.2.The ABG has to be analysed within 30 minutes . With these datas we can conclude the primary objective of whether this affects the neonatal outcomes or not.
时间窗: Blood pressure is measured every 1 minute till the delivery of the baby and then every 3 mins . | 2 The ABG is done within 30 minutes. | 3 The Apgar is measured in 1 minute, 3 minutes and 5 minutes.
次要结局
- 1 Incidence of hypotension more than 20 percent drop in Systolic Blood Pressure from the baseline among parturients undergoing elective LSCS under spinal anaesthesia.(2 To correlate the severity of hypotension ,mild , moderate, severe, with the neonatal outcomes)
