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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Active Comparator | 250 patients in this arm assigned to receive normal saline as the study fluid |
|
| Ringer's Lactate | Active Comparator | 250 patients in this arm assigned to receive Ringer's Lactate as the study fluid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% Normal Saline | Drug | Crystalloid fluid |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Maternal pH from preoperative baseline | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal pH | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel T Ayebale, Anaesthesia | Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago Hospital Labour Suite Operating Theatre | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28682955 | Derived | 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. |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Ringer's Lactate | Drug | Crystalloid fluid |
|
|
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 | 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 |