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Completed

NCT Number: NCT01585740

Ringer's Lactate Versus Normal Saline in Caesarean Section

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.

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Key information

Conditions

Normal Anion Gap Metabolic Acidosis Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mulago Hospital Labour Suite Operating Theatre

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.9% normal saline

Drug

Crystalloid fluid

Other names: Normal saline

Ringer's Lactate

Drug

Crystalloid fluid

Other names: Lactated Ringer's, Hartmann's Solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 26, 2012
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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