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Ringer's Lactate Versus Normal Saline in Caesarean Section

Primary Purpose

Normal Anion Gap Metabolic Acidosis

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
0.9% Normal Saline
Ringer's Lactate
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Anion Gap Metabolic Acidosis focused on measuring Hyperchloraemic metabolic acidosis, Neonatal acidosis, Neonatal hyperchloraemia, Base excess, Metabolic acidosis, Caesarean section, Normal saline, Ringer's Lactate, Postoperative morbidity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Mulago Hospital Labour Suite Operating Theatre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normal Saline

Ringer's Lactate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neonatal pH
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
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
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.

Full Information

First Posted
April 5, 2012
Last Updated
June 13, 2012
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT01585740
Brief Title
Ringer's Lactate Versus Normal Saline in Caesarean Section
Official Title
Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makerere University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Anion Gap Metabolic Acidosis
Keywords
Hyperchloraemic metabolic acidosis, Neonatal acidosis, Neonatal hyperchloraemia, Base excess, Metabolic acidosis, Caesarean section, Normal saline, Ringer's Lactate, Postoperative morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Active Comparator
Arm Description
250 patients in this arm assigned to receive normal saline as the study fluid
Arm Title
Ringer's Lactate
Arm Type
Active Comparator
Arm Description
250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
Intervention Type
Drug
Intervention Name(s)
0.9% Normal Saline
Other Intervention Name(s)
Normal saline
Intervention Description
Crystalloid fluid
Intervention Type
Drug
Intervention Name(s)
Ringer's Lactate
Other Intervention Name(s)
Lactated Ringer's, Hartmann's Solution
Intervention Description
Crystalloid fluid
Primary Outcome Measure Information:
Title
Change in Maternal pH from preoperative baseline
Description
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.
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Neonatal pH
Description
A sample of umbilical arterial cord blood will be drawn after ligating the cord to measure neonatal pH
Time Frame
Within 30 seconds of umbilical cord ligature
Title
Change in maternal base excess from preoperative baseline
Description
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.
Time Frame
Intraoperatively
Title
Number of mothers with postoperative morbidity events
Description
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.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel T Ayebale, Anaesthesia
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital Labour Suite Operating Theatre
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
28682955
Citation
Ayebale ET, Kwizera A, Mijumbi C, Kizito S, Roche AM. Ringer's Lactate Versus Normal Saline in Urgent Cesarean Delivery in a Resource-Limited Setting: A Pragmatic Clinical Trial. Anesth Analg. 2017 Aug;125(2):533-539. doi: 10.1213/ANE.0000000000002229.
Results Reference
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Ringer's Lactate Versus Normal Saline in Caesarean Section

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