- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585740
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
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kampala, Uganda
- Mulago Hospital Labour Suite Operating Theatre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
ACTIVE_COMPARATOR: Ringer's Lactate
250 patients in this arm assigned to receive Ringer's Lactate as the study fluid
|
Crystalloid fluid
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Emmanuel T Ayebale, Anaesthesia, Makerere University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FluidObs-1
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.
Clinical Trials on Normal Anion Gap Metabolic Acidosis
-
Istanbul UniversityRecruitingAnesthesia | Transurethral Resection of Prostate | Normal Anion Gap Metabolic Acidosis | Hyperchloremic AcidosisTurkey
-
Changi General HospitalCompletedCritical Illness | Metabolic Acidosis | Anion Gap Acidosis | Lactic Acidosis | Keto Acidosis | Acid Base DisorderSingapore
-
Mervat Mokhles Fathi SayedAssiut UniversityNot yet recruitingCorrelation Between Serum Chloride and Anion Gap in DKA PatientsEgypt
-
DLR German Aerospace CenterCharite University, Berlin, Germany; University of Erlangen-NürnbergCompleted
-
University of FloridaCompleted
-
Hvidovre University HospitalElsassFondenTerminatedMetabolic Acidosis of NewbornDenmark
-
Central Hospital, Nancy, FranceRecruiting
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...CompletedLactic Acidosis | MetforminItaly
-
National Institute of Environmental Health Sciences...Completed
-
Tri-Service General HospitalCompleted
Clinical Trials on 0.9% Normal Saline
-
Ann & Robert H Lurie Children's Hospital of ChicagoWithdrawn
-
University of HaifaWestern Galilee Hospital-NahariyaRecruiting
-
Virginia Commonwealth UniversityUnited States Department of DefenseWithdrawn
-
Vanderbilt University Medical CenterActive, not recruitingPostural Tachycardia SyndromeUnited States
-
Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Center for Research...Active, not recruitingOrthostatic Intolerance | Postural Tachycardia Syndrome | Orthostatic TachycardiaUnited States
-
Taipei Veterans General Hospital, TaiwanUnknown
-
Lawson Health Research InstituteCompleted
-
Tehran University of Medical SciencesTehran Heart CenterCompletedContrast Induced NephropathyIran, Islamic Republic of
-
University Hospital Inselspital, BerneCompletedCardiovascular Diseases | Valvular Heart DiseaseSwitzerland
-
Yasser S Mostafa, MDFayoum University HospitalRecruiting