Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Maternal pH from preoperative baseline
研究概览
简要总结
The objective of this study is to compare the effect on mean maternal and neonatal pH, and 24-hour postoperative morbidity, following intraoperative infusion of Ringer's Lactated versus normal saline in caesarean section at Mulago Hospital.
The null hypothesis is that intraoperative infusion of Ringer's Lactate in caesarean section at Mulago Hospital will not result in 30% less mean maternal and neonatal pH change than intraoperative infusion of normal saline.
详细描述
Fluid therapy in caesarean section surgery in Mulago Hospital is done mostly with 0.9% normal saline (NS). Several studies have highlighted the complications associated with large infusion of normal saline. Few studies have compared the effects of an alternative crystalloid, Ringer's Lactate (RL), on perinatal pH and postoperative morbidity in caesarean section surgery.
This trial will be performed in Mulago Hospital Labour Ward theatre on parturients who consent and are scheduled for either elective or emergency caesarean section under spinal anaesthesia from September 2011 to May 2012. Study fluid will be administered intraoperatively only. Preoperative and postoperative venous blood samples will be drawn for venous blood gases, serum urea and creatinine. Placental umbilical arterial cord blood will also be drawn for neonatal arterial blood gases. Mothers will be followed up for 24 hours for incidence of postoperative morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All parturients who consent for the study.
- •Up to American Society of Anesthesiology (ASA) class ІІ/E.
排除标准
- •Failed spinal anaesthesia that has to be converted to general anaesthesia.
研究组 & 干预措施
Normal Saline
250 patients in this arm assigned to receive normal saline as the study fluid
干预措施: 0.9% Normal Saline (Drug)
Ringer's Lactate
250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
干预措施: Ringer's Lactate (Drug)
结局指标
主要结局
Change in Maternal pH from preoperative baseline
时间窗: Intraoperatively
The aim is to study the effect of the study fluid on maternal pH. pH will be measured preoperatively and immediately postoperatively before the patient leaves the recovery room.
次要结局
- Neonatal pH(Within 30 seconds of umbilical cord ligature)
- Change in maternal base excess from preoperative baseline(Intraoperatively)
- Number of mothers with postoperative morbidity events(24 hours postoperatively)
研究者
Faculty of Medicine
Dr. Emmanuel Timarwa Ayebale
Makerere University