Clinical Trial: Ringer's Lactate Versus Normal Saline in Caesarean Section

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial

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 Summary:

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.


Sponsor: Makerere University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Neonatal pH [ Time Frame: Within 30 seconds of cord clumping and cutting ]
    A sample of umbilical arterial cord blood will be drawn after clumping and cutting 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.


Information By: Makerere University

Dates:
Date Received: April 5, 2012
Date Started: September 2011
Date Completion:
Last Updated: June 13, 2012
Last Verified: June 2012