Ringer's Lactate Versus Normal Saline in Caesarean Section

NCT ID: NCT01585740

Last Updated: 2012-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Normal Anion Gap Metabolic Acidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Saline

250 patients in this arm assigned to receive normal saline as the study fluid

Group Type ACTIVE_COMPARATOR

0.9% Normal Saline

Intervention Type DRUG

Crystalloid fluid

Ringer's Lactate

250 patients in this arm assigned to receive Ringer's Lactate as the study fluid

Group Type ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type DRUG

Crystalloid fluid

Interventions

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0.9% Normal Saline

Crystalloid fluid

Intervention Type DRUG

Ringer's Lactate

Crystalloid fluid

Intervention Type DRUG

Other Intervention Names

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Normal saline Lactated Ringer's Hartmann's Solution

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine

Dr. Emmanuel Timarwa Ayebale

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanuel T Ayebale, Anaesthesia

Role: PRINCIPAL_INVESTIGATOR

Makerere University

Locations

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Mulago Hospital Labour Suite Operating Theatre

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 28682955 (View on PubMed)

Other Identifiers

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FluidObs-1

Identifier Type: -

Identifier Source: org_study_id

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