HypotensionADIVANCT03620942
Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System
A study testing Phenylephrine, Ephedrine and ADIVA System in people with Hypotension and Anesthesia, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Hypotension, Anesthesia
- What is being tested?
- Phenylephrine, Ephedrine and ADIVA System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Nov 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients;
- With singleton full-term pregnancy;
- The indication for an elective cesarean delivery;
- The use of spinal anaesthesia for cesarean delivery;
- Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm.
Who cannot join
- Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
- Contraindication to spinal anaesthesia and/or allergy to opioids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section
Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.
Read the detailed description
The incidence of maternal hypotension during spinal anaesthesia for Caesarean delivery is reported to be as high as 70-90%. The potential adverse effects resulting from maternal hypotension are nausea, vomiting, cardiac dysfunction, foetal acidosis and hypoxia.
Hypotension during spinal anaesthesia is currently detected using an intermittent blood pressure (BP) monitor cycling and reactive administration of vasopressors upon detection. The use of conventional non-invasive BP monitoring is limited by the time required to inflate and to deflate the cuffs commonly applied to the arm, which subsequently leads to a failure to react in a timely manner to BP changes when they occur.
The DIVA system (double-intravenous vasopressor automated system) previously developed helped tackle the limitations associated with the conventional management of hypotension in Caesarean sections under spinal anaesthesia. In a recent randomized controlled trial the DIVA system achieved less incidence of maternal hypotension compared to conventional management, however the side effects in mother and baby were still not fully eliminated.
In this proposed study a new algorithm for an advanced DIVA (ADIVA) system will be developed to control BP more rigorously by detecting BP with more stable haemodynamic profiles and thereby improve patient outcomes. The clinical trial will be conducted in 2 phases. The first phase included the use of ADIVA in 76 subjects who undergo spinal anaesthesia for Caesarean delivery to test its safety and efficacy. The second phase was a randomised controlled trial to investigate the use of ADIVA in comparison to the existing DIVA system in 97 patients undergoing spinal anaesthesia for Caesarean section.
- Conditions
- Hypotension, Anesthesia
- Being tested
- Phenylephrine, Ephedrine, ADIVA System, DIVA System
- Keywords
- Maternal hypotension, Spinal anaesthesia, Caesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Vasopressor
Phenylephrine will be administered with conditions as below:
- When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min;
- When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min.
EphedrineDrug
Also called Vasopressor
Ephedrine will be administered with conditions as below:
- When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min;
- When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min.
ADIVA SystemDevice
Also called Advanced Double Intravenous Vasopressor Automated System
- When systolic blood pressure (SBP) is 100-110% of baseline, 25mcg phenylephrine (infusion) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion) is given if heart rate < 60 beats/min;
- When SBP is 90-100% of baseline, 25mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min;
- When SBP is 80-90% of baseline, 50mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 4mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min;
- When SBP < 80% of baseline, 75mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 6mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min.
DIVA SystemDevice
Also called Double Intravenous Vasopressor Automated System
DIVA system works as below:
- When systolic blood pressure is between 90 to 100% of baseline, 25mcg phenylephrine (bolus) will be given if heart rate ≥ 60 beats/min, whereas 2mg ephedrine (bolus) will be given if heart rate < 60 beats/min;
- When systolic blood pressure is less than 90% of baseline, 50mcg phenylephrine (infusion or bolus) will be given if heart rate ≥ 60 beats/min, whereas 4mg ephedrine (infusion or bolus) will be given if heart rate < 60 beats/min.
| Study group | Role | What they receive |
|---|---|---|
| ADIVA system | Experimental | Vasopressor delivery automated system administering phenylephrine and ephedrine using a three-step algorithm vasopressor delivery technique Receives: Drug: Phenylephrine; Drug: Ephedrine; Device: ADIVA System |
| DIVA system | Active comparator | Vasopressor delivery automated system administering phenylephrine and ephedrine using a two-step algorithm vasopressor delivery technique Receives: Drug: Phenylephrine; Drug: Ephedrine; Device: DIVA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of events of Hypotension occurrence
Systolic blood pressure less than 80% of baseline systolic blood pressure
Measured: 1 day (during cesarean delivery)
Secondary outcomes (2)
Number of events of Hypertension occurrence
Systolic blood pressure more than 120% of baseline systolic blood pressure
Measured: 1 day (during cesarean delivery)
Number of events of Nausea and vomiting occurrence
Nausea and vomiting during and after cesarean delivery
Measured: 1 day (during and after cesarean delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start7 Nov 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Model description
- The first phase recruited 76 parturients. The second phase recruited 97 parturients. Parturients recruited from this phase will be randomized into either ADIVA group or DIVA group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Singaraselvan Nagarajan, FCARCSI, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620942
- Sponsor's protocol ID
- SHF/CTG061/2017
- Acronym
- ADIVA
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2018
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan HS, Nagarajan S, Chan JJI, Tan CW, Sultana R, Sia ATH, Sng BL. Evaluating an advanced double intravenous vasopressor automated system to treat hypotension during spinal anesthesia for cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 26;23(1):33. doi: 10.1186/s12871-023-01992-7.
PubMed 36703120Nagarajan S, Chan JJI, Tan CW, Al-Hashim ZGA, Sultana R, Sia ATH, Sng BL. An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study. Eur J Anaesthesiol. 2022 Jan 1;39(1):42-49. doi: 10.1097/EJA.0000000000001496.
PubMed 33831901
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section
- ClinicalTrials.gov ID
- NCT03620942
- Acronym / sponsor ID
- ADIVA / SHF/CTG061/2017
- Conditions
- Hypotension, Anesthesia
- Keywords
- Maternal hypotension, Spinal anaesthesia, Caesarean section
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 2018 (actual)
- 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.
Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.
Detailed description
The incidence of maternal hypotension during spinal anaesthesia for Caesarean delivery is reported to be as high as 70-90%. The potential adverse effects resulting from maternal hypotension are nausea, vomiting, cardiac dysfunction, foetal acidosis and hypoxia.
Hypotension during spinal anaesthesia is currently detected using an intermittent blood pressure (BP) monitor cycling and reactive administration of vasopressors upon detection. The use of conventional non-invasive BP monitoring is limited by the time required to inflate and to deflate the cuffs commonly applied to the arm, which subsequently leads to a failure to react in a timely manner to BP changes when they occur.
The DIVA system (double-intravenous vasopressor automated system) previously developed helped tackle the limitations associated with the conventional management of hypotension in Caesarean sections under spinal anaesthesia. In a recent randomized controlled trial the DIVA system achieved less incidence of maternal hypotension compared to conventional management, however the side effects in mother and baby were still not fully eliminated.
In this proposed study a new algorithm for an advanced DIVA (ADIVA) system will be developed to control BP more rigorously by detecting BP with more stable haemodynamic profiles and thereby improve patient outcomes. The clinical trial will be conducted in 2 phases. The first phase included the use of ADIVA in 76 subjects who undergo spinal anaesthesia for Caesarean delivery to test its safety and efficacy. The second phase was a randomised controlled trial to investigate the use of ADIVA in comparison to the existing DIVA system in 97 patients undergoing spinal anaesthesia for Caesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The first phase recruited 76 parturients. The second phase recruited 97 parturients. Parturients recruited from this phase will be randomized into either ADIVA group or DIVA group.
| Arm | Type | Receives |
|---|---|---|
| ADIVA system | Experimental | Drug: Phenylephrine, Drug: Ephedrine, Device: ADIVA SystemVasopressor delivery automated system administering phenylephrine and ephedrine using a three-step algorithm vasopressor delivery technique |
| DIVA system | Active comparator | Drug: Phenylephrine, Drug: Ephedrine, Device: DIVA SystemVasopressor delivery automated system administering phenylephrine and ephedrine using a two-step algorithm vasopressor delivery technique |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients;
- With singleton full-term pregnancy;
- The indication for an elective cesarean delivery;
- The use of spinal anaesthesia for cesarean delivery;
- Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm.
Key exclusion criteria (2 listed)
- Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
- Contraindication to spinal anaesthesia and/or allergy to opioids.
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 |
|---|---|---|
| PhenylephrineAlso: VasopressorPhenylephrine will be administered with conditions as below: 1. When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min; 2. When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min. | Drug | ADIVA system, DIVA system |
| EphedrineAlso: VasopressorEphedrine will be administered with conditions as below: 1. When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min; 2. When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min. | Drug | ADIVA system, DIVA system |
| ADIVA SystemAlso: Advanced Double Intravenous Vasopressor Automated System1. When systolic blood pressure (SBP) is 100-110% of baseline, 25mcg phenylephrine (infusion) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion) is given if heart rate < 60 beats/min; 2. When SBP is 90-100% of baseline, 25mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min; 3. When SBP is 80-90% of baseline, 50mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 4mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min; 4. When SBP < 80% of baseline, 75mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 6mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min. | Device | ADIVA system |
| DIVA SystemAlso: Double Intravenous Vasopressor Automated SystemDIVA system works as below: 1. When systolic blood pressure is between 90 to 100% of baseline, 25mcg phenylephrine (bolus) will be given if heart rate ≥ 60 beats/min, whereas 2mg ephedrine (bolus) will be given if heart rate < 60 beats/min; 2. When systolic blood pressure is less than 90% of baseline, 50mcg phenylephrine (infusion or bolus) will be given if heart rate ≥ 60 beats/min, whereas 4mg ephedrine (infusion or bolus) will be given if heart rate < 60 beats/min. | Device | DIVA system |
Primary outcome
Number of events of Hypotension occurrence
Time frame: 1 day (during cesarean delivery)
Systolic blood pressure less than 80% of baseline systolic blood pressure
2 secondary outcomes
Number of events of Hypertension occurrence
Time frame: 1 day (during cesarean delivery)
Number of events of Nausea and vomiting occurrence
Time frame: 1 day (during and after cesarean delivery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 36703120Tan HS, Nagarajan S, Chan JJI, Tan CW, Sultana R, Sia ATH, Sng BL. Evaluating an advanced double intravenous vasopressor automated system to treat hypotension during spinal anesthesia for cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 26;23(1):33. doi: 10.1186/s12871-023-01992-7.
- Derived from this study: PubMed 33831901Nagarajan S, Chan JJI, Tan CW, Al-Hashim ZGA, Sultana R, Sia ATH, Sng BL. An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study. Eur J Anaesthesiol. 2022 Jan 1;39(1):42-49. doi: 10.1097/EJA.0000000000001496.
- Individual participant dataSharing planned: No
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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.
Singaraselvan Nagarajan, FCARCSI principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine, Ephedrine and ADIVA System in people with Hypotension and Anesthesia, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of events of Hypotension occurrence (time frame: 1 day (during cesarean delivery)). 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 NCT03620942, which also lists 2 linked publications.
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 Aug 2026.