Ringer's Lactate Versus Normal Saline in Caesarean Section

Not Applicable

Completed

• Conditions: Normal Anion Gap Metabolic Acidosis
• Interventions: Drug: 0.9% Normal Saline; Drug: Ringer's Lactate

• Registration Number: NCT01585740
• Lead Sponsor: Makerere University

Brief 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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-26
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	0.9% Normal Saline	250 patients in this arm assigned to receive normal saline as the study fluid
Ringer's Lactate	Ringer's Lactate	250 patients in this arm assigned to receive Ringer's Lactate as the study fluid

Primary Outcome Measures

Name	Time	Method
Change in Maternal pH from preoperative baseline	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.

Secondary Outcome Measures

Name	Time	Method
Neonatal pH	Within 30 seconds of umbilical cord ligature	A sample of umbilical arterial cord blood will be drawn after ligating the cord to measure neonatal pH
Change in maternal base excess from preoperative baseline	Intraoperatively	The aim is to study the effect of the study fluid on maternal base excess. Base excess will be measured preoperatively and immediately postoperatively before the patient leaves the recovery room.
Number of mothers with postoperative morbidity events	24 hours postoperatively	Using a Post-Operative Morbidity Survey (POMS) mothers will be followed up postoperatively for 24 hours assessing incidence of morbidity in the following systems: Pulmonary, Renal, Gastrointestinal, Cardiovascular, Neurological, and Hematological.

Trial Locations

Locations (1)

Mulago Hospital Labour Suite Operating Theatre; 🇺🇬 Kampala, Uganda