Ringer's Lactate Versus Normal Saline in Caesarean Section
NCT ID: NCT01585740
Last Updated: 2012-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2011-09-30
2012-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Normal Saline
250 patients in this arm assigned to receive normal saline as the study fluid
0.9% Normal Saline
Crystalloid fluid
Ringer's Lactate
250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
Ringer's Lactate
Crystalloid fluid
Interventions
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0.9% Normal Saline
Crystalloid fluid
Ringer's Lactate
Crystalloid fluid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Up to American Society of Anesthesiology (ASA) class ІІ/E.
Exclusion Criteria
FEMALE
No
Sponsors
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Makerere University
OTHER
Responsible Party
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Faculty of Medicine
Dr. Emmanuel Timarwa Ayebale
Principal Investigators
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Emmanuel T Ayebale, Anaesthesia
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Locations
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Mulago Hospital Labour Suite Operating Theatre
Kampala, , Uganda
Countries
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References
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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.
Other Identifiers
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FluidObs-1
Identifier Type: -
Identifier Source: org_study_id
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