Ringer's Lactate Versus Normal Saline in Caesarean Section

Makerere University

Status: Completed

Conditions: Normal Anion Gap Metabolic Acidosis

Treatments: Drug: 0.9% Normal Saline; Drug: Ringer's Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT01585740

FluidObs-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• All parturients who consent for the study.
• Up to American Society of Anesthesiology (ASA) class ІІ/E.

Exclusion criteria

• Failed spinal anaesthesia that has to be converted to general anaesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Normal Saline

Active Comparator group

Description:

250 patients in this arm assigned to receive normal saline as the study fluid

Treatment:

Drug: 0.9% Normal Saline

Ringer's Lactate

Active Comparator group

Description:

250 patients in this arm assigned to receive Ringer's Lactate as the study fluid

Treatment:

Drug: Ringer's Lactate