Ringer's Lactate Versus Normal Saline in Caesarean Section
Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 14, 2012
June 1, 2012
7 months
April 5, 2012
June 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Neonatal pH
Within 30 seconds of umbilical cord ligature
Change in maternal base excess from preoperative baseline
Intraoperatively
Number of mothers with postoperative morbidity events
24 hours postoperatively
Study Arms (2)
Normal Saline
ACTIVE COMPARATOR250 patients in this arm assigned to receive normal saline as the study fluid
Ringer's Lactate
ACTIVE COMPARATOR250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
Interventions
Crystalloid fluid
Eligibility Criteria
You may qualify if:
- All parturients who consent for the study.
- Up to American Society of Anesthesiology (ASA) class ІІ/E.
You may not qualify if:
- Failed spinal anaesthesia that has to be converted to general anaesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mulago Hospital Labour Suite Operating Theatre
Kampala, Uganda
Related Publications (1)
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.
PMID: 28682955DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel T Ayebale, Anaesthesia
Makerere University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Emmanuel Timarwa Ayebale
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 26, 2012
Study Start
September 1, 2011
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
June 14, 2012
Record last verified: 2012-06