Ringer's Lactate Versus Normal Saline in Caesarean Section
|ClinicalTrials.gov Identifier: NCT01585740|
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : June 14, 2012
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 or disease||Intervention/treatment|
|Normal Anion Gap Metabolic Acidosis||Drug: 0.9% Normal Saline Drug: Ringer's Lactate|
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 (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial|
|Study Start Date :||September 2011|
|Primary Completion Date :||April 2012|
|Study Completion Date :||May 2012|
Active Comparator: Normal Saline
250 patients in this arm assigned to receive normal saline as the study fluid
Drug: 0.9% Normal Saline
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
- 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.
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585740
|Mulago Hospital Labour Suite Operating Theatre|
|Principal Investigator:||Emmanuel T Ayebale, Anaesthesia||Makerere University|