NCT01585740

Ringer's Lactate Versus Normal Saline in Caesarean Section

Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Normal Anion Gap Metabolic Acidosis

Interventions

Type	Name	Description
DRUG	0.9% Normal Saline	Crystalloid fluid
DRUG	Ringer's Lactate	Crystalloid fluid

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2012-04-26
• Last updated: 2012-06-14

Locations

1 site across 1 country: Uganda