Clinical trial NCT01585740: Ringer's Lactate Versus Normal Saline in Caesarean Section
Official title: Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Anion Gap Metabolic Acidosis
Keywords: Hyperchloraemic metabolic acidosis
Neonatal acidosis
Neonatal hyperchloraemia
Base excess
Metabolic acidosis
Caesarean section
Normal saline
Ringer's Lactate
Postoperative morbidity
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in Maternal pH from preoperative baseline
timeFrame: Intraoperatively
Secondary outcomes:
measure: Neonatal pH
timeFrame: Within 30 seconds of umbilical cord ligature
measure: Change in maternal base excess from preoperative baseline
timeFrame: Intraoperatively
measure: Number of mothers with postoperative morbidity events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital Labour Suite Operating Theatre
Study officials:
affiliation: Makerere University
name: Emmanuel T Ayebale, Anaesthesia
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.