Normal Anion Gap Metabolic Acidosis Clinical Trial
Official title:
Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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