Ringer's Lactate Versus Normal Saline in Caesarean Section

June 13, 2012 updated by: Faculty of Medicine, Makerere University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kampala, Uganda
        • Mulago Hospital Labour Suite Operating Theatre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Normal Saline
250 patients in this arm assigned to receive normal saline as the study fluid
Crystalloid fluid
Other Names:
  • Normal saline
ACTIVE_COMPARATOR: Ringer's Lactate
250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
Crystalloid fluid
Other Names:
  • Hartmann's Solution
  • Lactated Ringer's

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal pH
Time Frame: 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
Within 30 seconds of umbilical cord ligature
Change in maternal base excess from preoperative baseline
Time Frame: 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.
Intraoperatively
Number of mothers with postoperative morbidity events
Time Frame: 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.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emmanuel T Ayebale, Anaesthesia, Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (ESTIMATE)

April 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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