Ringer's Lactate Versus Normal Saline in Caesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University
ClinicalTrials.gov Identifier:
NCT01585740
First received: April 5, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Normal Anion Gap Metabolic Acidosis
Drug: 0.9% Normal Saline
Drug: Ringer's Lactate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Change in Maternal pH from preoperative baseline [ Time Frame: Intraoperatively ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Within 30 seconds of umbilical cord ligature ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Intraoperatively ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 500
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal Saline
250 patients in this arm assigned to receive normal saline as the study fluid
Drug: 0.9% Normal Saline
Crystalloid fluid
Other Name: Normal saline
Active Comparator: Ringer's Lactate
250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
Drug: Ringer's Lactate
Crystalloid fluid
Other Names:
  • Lactated Ringer's
  • Hartmann's Solution

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585740

Locations
Uganda
Mulago Hospital Labour Suite Operating Theatre
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Investigators
Principal Investigator: Emmanuel T Ayebale, Anaesthesia Makerere University
  More Information

No publications provided

Responsible Party: Faculty of Medicine, Dr. Emmanuel Timarwa Ayebale, Makerere University
ClinicalTrials.gov Identifier: NCT01585740     History of Changes
Other Study ID Numbers: FluidObs-1
Study First Received: April 5, 2012
Last Updated: June 13, 2012
Health Authority: Uganda: Research Ethics Committee
Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Hyperchloraemic metabolic acidosis
Neonatal acidosis
Neonatal hyperchloraemia
Base excess
Metabolic acidosis
Caesarean section
Normal saline
Ringer's Lactate
Postoperative morbidity

Additional relevant MeSH terms:
Acidosis
Acid-Base Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014