Ringer's Lactate Versus Normal Saline in Caesarean Section

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585740
• Other study ID #: FluidObs-1
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: June 13, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics CommitteeUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All parturients who consent for the study.

• Up to American Society of Anesthesiology (ASA) class ??/E.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acidosis
• Normal Anion Gap Metabolic Acidosis

Intervention

Drug:
• 0.9% Normal Saline
Crystalloid fluid
• Ringer's Lactate
Crystalloid fluid

Locations

Country	Name	City	State
Uganda	Mulago Hospital Labour Suite Operating Theatre	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes