Normal Anion Gap Metabolic AcidosisNCT01585740
Ringer's Lactate Versus Normal Saline in Caesarean Section
A study testing 0.9% Normal Saline and Ringer's Lactate in people with Normal Anion Gap Metabolic Acidosis, run by Makerere University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Normal Anion Gap Metabolic Acidosis
- What is being tested?
- 0.9% Normal Saline and Ringer's Lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All parturients who consent for the study.
- Up to American Society of Anesthesiology (ASA) class ІІ/E.
Who cannot join
- Failed spinal anaesthesia that has to be converted to general anaesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
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.
Read the 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.
- Conditions
- Normal Anion Gap Metabolic Acidosis
- Being tested
- 0.9% Normal Saline, Ringer's Lactate
- Keywords
- Hyperchloraemic metabolic acidosis, Neonatal acidosis, Neonatal hyperchloraemia, Base excess, Metabolic acidosis, Caesarean section, Normal saline, Ringer's Lactate, Postoperative morbidity
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Normal SalineDrug
Also called Normal saline
Crystalloid fluid
Ringer's LactateDrug
Also called Lactated Ringer's, Hartmann's Solution
Crystalloid fluid
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | 250 patients in this arm assigned to receive normal saline as the study fluid Receives: Drug: 0.9% Normal Saline |
| Ringer's Lactate | Active comparator | 250 patients in this arm assigned to receive Ringer's Lactate as the study fluid Receives: Drug: Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively
Secondary outcomes (3)
Neonatal pH
A sample of umbilical arterial cord blood will be drawn after ligating the cord to measure neonatal pH
Measured: Within 30 seconds of umbilical cord ligature
Change in maternal base excess from preoperative baseline
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.
Measured: 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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Anion Gap Metabolic AcidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faculty of Medicine, Makerere University
- Investigators
- Emmanuel T Ayebale, Anaesthesia, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585740
- Sponsor's protocol ID
- FluidObs-1
- Status last verified
- Jun 2012
- First submitted
- 5 Apr 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28682955
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ringer's Lactate on Maternal and Neonatal pH in Caesarean Section at Mulago Hospital, a Randomized Trial
- ClinicalTrials.gov ID
- NCT01585740
- Acronym / sponsor ID
- FluidObs-1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Drug: 0.9% Normal Saline250 patients in this arm assigned to receive normal saline as the study fluid |
| Ringer's Lactate | Active comparator | Drug: Ringer's Lactate250 patients in this arm assigned to receive Ringer's Lactate as the study fluid |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All parturients who consent for the study.
- Up to American Society of Anesthesiology (ASA) class ІІ/E.
Key exclusion criteria (1 listed)
- Failed spinal anaesthesia that has to be converted to general anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% Normal SalineAlso: Normal salineCrystalloid fluid | Drug | Normal Saline |
| Ringer's LactateAlso: Lactated Ringer's, Hartmann's SolutionCrystalloid fluid | Drug | Ringer's Lactate |
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.
3 secondary outcomes
Neonatal pH
Time frame: Within 30 seconds of umbilical cord ligature
Change in maternal base excess from preoperative baseline
Time frame: Intraoperatively
Number of mothers with postoperative morbidity events
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Derived from this study: PubMed 28682955Ayebale 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel T Ayebale, Anaesthesia principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% Normal Saline and Ringer's Lactate in people with Normal Anion Gap Metabolic Acidosis, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal pH from preoperative baseline (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.