Ringer's Lactate Versus Normal Saline in Caesarean Section

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Normal Anion Gap Metabolic Acidosis

Intervention / Treatment
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* Drug: 0.9% Normal Saline
* Drug: Ringer's Lactate


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Saline<br>250 patients in this arm assigned to receive normal saline as the study fluid | Drug: 0.9% Normal Saline<br>* Crystalloid fluid<br>* Other names: Normal saline;|
| Active Comparator: Ringer's Lactate<br>250 patients in this arm assigned to receive Ringer's Lactate as the study fluid | Drug: Ringer's Lactate<br>* Crystalloid fluid<br>* Other names: Hartmann's Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maternal pH from preoperative baseline | 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. | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal pH | A sample of umbilical arterial cord blood will be drawn after ligating the cord to measure neonatal pH | Within 30 seconds of umbilical cord ligature | 
| Change in maternal base excess from preoperative baseline | 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. | Intraoperatively | 
| Number of mothers with postoperative morbidity events | 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. | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperchloraemic metabolic acidosis, Neonatal acidosis, Neonatal hyperchloraemia, Base excess, Metabolic acidosis, Caesarean section, Normal saline, Ringer's Lactate, Postoperative morbidity