Pregnancy RelatedNCT06892665
The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections
A study testing Hypotension prediction index and Non invasive Blood Pressure Monitoring in people with Pregnancy Related and Hypotension, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
During caesarean section, blood pressure variations especially a reduction in blood pressure (or hypotension) can bring harmful effects to mother and baby. This usually occurs after spinal anaesthesia is administered. Usually, the anaesthetist will treat hypotension as it occurs. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Related, Hypotension, Maternal-Fetal Relations
- What is being tested?
- Hypotension prediction index and Non invasive Blood Pressure Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2024to 31 Dec 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≥ 37 weeks of gestation
- Elective CS
- Age between 18 - 40 years old
- Singleton pregnancy
- Planned for spinal anaesthesia
Who cannot join
- American Society of Anesthesiologists (ASA) III and above
- Body mass index (BMI) ≥ 40 kg/m2
- Increased risk of developing peripartum haemorrhage
- History of peripartum haemorrhage
- Placenta previa major, accrete, increta, percreta
- Gravida ≥ 5
Show all 12Show fewer
- Presence of large uterine fibroids
- Congenital bleeding disorders such as Haemophilia A, Haemophilia B and Von Willebrand disease
- Acquired bleeding disorders such as thrombocytopenia and coagulopathy
- Contraindications to finger cuff orNIBP application, such as finger ischaemia, upper limb neurological deficit, discoloured nail
- Cardiac arrhythmias and aortic regurgitation
- Patient's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Using Hypotension Prediction Index To Reduce Intraoperative Hypotension In Caesarean Sections: A Randomised Controlled Trial
During caesarean section, blood pressure variations especially a reduction in blood pressure (or hypotension) can bring harmful effects to mother and baby. This usually occurs after spinal anaesthesia is administered. Usually, the anaesthetist will treat hypotension as it occurs. However, a new medical device is now available to predict hypotension. It is called the Hypotension Prediction Index (HPI). This device allows the prediction of hypotension; hence, treatment can be given before it occurs. It has been widely utilised in major surgeries like abdominal tumour surgery and cardiac surgery worldwide and has shown a substantial reduction in hypotension. This study aims to determine whether the duration and severity of hypotension can be reduced when HPI is used in lower segment caesarean sections. The secondary objective of the study is to determine if the complication rate can be reduced in both mother and baby.
Read the detailed description
Hypotension Prediction Index (HPI) has been shown to reduce IOH significantly in non-cardiac and major abdominal surgeries.The role of HPI beyond reducing IOH has also been a subject of research. Andrzejeska et al. demonstrated that the use of HPI in adolescent idiopathic scoliosis surgery leads to lower reductions in post-surgery haemoglobin levels, shorter duration of hypotension and shorter hospital admissions. Additionally, the intervention group had shorter timeframes from the end of surgery to extubation.
The development of a non-invasive finger blood pressure device compatible with HPI called the Acumen IQ cuff, made it possible to use HPI without inserting an arterial catheter. The arterial pressure waveform generated by a non-invasive finger cuff was reliable and in agreement with the radial artery blood pressure. A retrospective analysis was conducted by Frassanito et al. to determine the performance of HPI using arterial waveform recorded by a non-invasive finger probe to predict hypotension in patients undergoing CS under spinal anaesthesia. They have found that HPI, using this non-invasive probe, was able to predict hypotension with a sensitivity and specificity of 83% and 83% at 3 minutes, 97% and 97% at 2 minutes, and 100% and 100% at 1 minute, before it occurs.
This study aims to determine if the solution to reduce IOH lies in predicting intraoperative hypotension during lower segment ceaserean section (CS). The benefits of HPI may extend beyond reducing the incidence and severity of IOH, to bringing positive outcomes to the foetus. This study will determine whether integrating an early warning system produces benefits significant enough to justify changing our anaesthetic practice.
PROBLEM STATEMENT
Varying methods have been utilised to reduce IOH in CS. A novel software, HPI, was developed to predict hypotension, enabling clinicians to institute guided treatment before maternal hypotension occurs. The investigator need to determine if HPI has benefits in CS, thus leading to better maternal and neonatal outcomes.
RESEARCH QUESTION
Can HPI using the non-invasive continuous arterial pressure waveforms reduce the duration and severity of hypotension in patients undergoing CS under spinal anaesthesia?
OBJECTIVES
Study objective:
To determine if HPI has benefits in CS, thus leading to better maternal and neonatal outcomes compared to oNIBP.
Primary outcome:
The duration and severity of hypotensive events reported as a time-weighted average (TWA) - MAP < 65 mmHg in HPI group (intervention) versus standard oNIBP.
Secondary outcomes:
- To determine whether the use of HPI leads to better maternal outcomes (incidence of nausea and vomiting, blood loss, length of hospital stay, maternal satisfaction, incidence of surgical site infection)
- To determine whether the use of HPI leads to better foetal outcomes (Apgar scores, umbilical cord pH, length of hospital stay)
- To determine the amount of vasopressors and inotropes administered throughout CS if HPI is used versus conventional oNIBP monitoring
RESEARCH HYPOTHESIS
Additional parameters from HPI in the CS under spinal anaesthesia will reduce the duration and severity of intraoperative hypotension and provide better maternal and neonatal outcomes.
- Being tested
- Hypotension prediction index, Non invasive Blood Pressure Monitoring
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension prediction indexDevice
Also called HPI
HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon
Non invasive Blood Pressure MonitoringDevice
Also called NIBP
Anaesthetist will respond to hemodynamic variables using NIBP
| Study group | Role | What they receive |
|---|---|---|
| Group 1: HPI Group | Experimental | There were 2 arm group, in Group 1the Acumen IQ cuff, with HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon. Receives: Device: Hypotension prediction index |
| Group 2: NIBP Group | Placebo comparator | the attending anaesthetist will be blinded from the HPI parameters. Receives: Device: Non invasive Blood Pressure Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average of Mean arterial pressure <65mmHg
Calculated using a formula. TWA-MAP < 65 mmHg = (the depth of hypotension< MAP of 65 mmHg x time spent below a MAP of 65 mmHg (minutes))/(total duration of operation (minutes))
Measured: From spinal anaesthesia to completion of surgery
Secondary outcomes (7)
Incidence of nausea and vomiting,
Maternal incidence of nausea and vomiting
Measured: Perioperative up to 2 days
length of hospital stay
maternal length of hospital stay
Measured: Perioperative up to 2 weeks
maternal satisfaction
Likert scale from 1 (very unsatisfied) to 5 (very satisfied)
Measured: Perioperative up to 2 weeks
incidence of surgical site infection
maternal surgical site infection
Measured: Perioperative up to 2 weeks
Apgar score of feotal
Apgar scores of 0-10 ( Apgar score of 7 and more is considered normal)
Measured: 1 minute and 5 minutes after delivery
Umbilical cord PH
Umbilical cord PH taken after after delivery of baby
Measured: Immediately upon delivery of baby
Neonatal length of stay
Neonatal length of stay
Measured: Perioperative up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, double-blinded, randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azlina Masdar, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892665
- Sponsor's protocol ID
- JEP-2024-463
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of the study will be available in public data repository
Publications
Murabito P, Astuto M, Sanfilippo F, La Via L, Vasile F, Basile F, Cappellani A, Longhitano L, Distefano A, Li Volti G. Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial. J Clin Med. 2022 Jan 13;11(2):392. doi: 10.3390/jcm11020392.
PubMed 35054083Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
PubMed 26181335Frassanito L, Sonnino C, Piersanti A, Zanfini BA, Catarci S, Giuri PP, Scorzoni M, Gonnella GL, Antonelli M, Draisci G. Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia. Anesth Analg. 2022 Mar 1;134(3):633-643. doi: 10.1213/ANE.0000000000005754.
PubMed 34591796Andrzejewska A, Miegon J, Zacha S, Skonieczna-Zydecka K, Jarosz K, Zacha W, Biernawska J. The Impact of Intraoperative Haemodynamic Monitoring, Prediction of Hypotension and Goal-Directed Therapy on the Outcomes of Patients Treated with Posterior Fusion Due to Adolescent Idiopathic Scoliosis. J Clin Med. 2023 Jul 9;12(14):4571. doi: 10.3390/jcm12144571.
PubMed 37510686
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Using Hypotension Prediction Index To Reduce Intraoperative Hypotension In Caesarean Sections: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06892665
- Acronym / sponsor ID
- JEP-2024-463
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Mar 2025 (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.
During caesarean section, blood pressure variations especially a reduction in blood pressure (or hypotension) can bring harmful effects to mother and baby. This usually occurs after spinal anaesthesia is administered. Usually, the anaesthetist will treat hypotension as it occurs. However, a new medical device is now available to predict hypotension. It is called the Hypotension Prediction Index (HPI). This device allows the prediction of hypotension; hence, treatment can be given before it occurs. It has been widely utilised in major surgeries like abdominal tumour surgery and cardiac surgery worldwide and has shown a substantial reduction in hypotension. This study aims to determine whether the duration and severity of hypotension can be reduced when HPI is used in lower segment caesarean sections. The secondary objective of the study is to determine if the complication rate can be reduced in both mother and baby.
Detailed description
Hypotension Prediction Index (HPI) has been shown to reduce IOH significantly in non-cardiac and major abdominal surgeries.The role of HPI beyond reducing IOH has also been a subject of research. Andrzejeska et al. demonstrated that the use of HPI in adolescent idiopathic scoliosis surgery leads to lower reductions in post-surgery haemoglobin levels, shorter duration of hypotension and shorter hospital admissions. Additionally, the intervention group had shorter timeframes from the end of surgery to extubation.
The development of a non-invasive finger blood pressure device compatible with HPI called the Acumen IQ cuff, made it possible to use HPI without inserting an arterial catheter. The arterial pressure waveform generated by a non-invasive finger cuff was reliable and in agreement with the radial artery blood pressure. A retrospective analysis was conducted by Frassanito et al. to determine the performance of HPI using arterial waveform recorded by a non-invasive finger probe to predict hypotension in patients undergoing CS under spinal anaesthesia. They have found that HPI, using this non-invasive probe, was able to predict hypotension with a sensitivity and specificity of 83% and 83% at 3 minutes, 97% and 97% at 2 minutes, and 100% and 100% at 1 minute, before it occurs.
This study aims to determine if the solution to reduce IOH lies in predicting intraoperative hypotension during lower segment ceaserean section (CS). The benefits of HPI may extend beyond reducing the incidence and severity of IOH, to bringing positive outcomes to the foetus. This study will determine whether integrating an early warning system produces benefits significant enough to justify changing our anaesthetic practice.
PROBLEM STATEMENT
Varying methods have been utilised to reduce IOH in CS. A novel software, HPI, was developed to predict hypotension, enabling clinicians to institute guided treatment before maternal hypotension occurs. The investigator need to determine if HPI has benefits in CS, thus leading to better maternal and neonatal outcomes.
RESEARCH QUESTION
Can HPI using the non-invasive continuous arterial pressure waveforms reduce the duration and severity of hypotension in patients undergoing CS under spinal anaesthesia?
OBJECTIVES
Study objective:
To determine if HPI has benefits in CS, thus leading to better maternal and neonatal outcomes compared to oNIBP.
Primary outcome:
The duration and severity of hypotensive events reported as a time-weighted average (TWA) - MAP < 65 mmHg in HPI group (intervention) versus standard oNIBP.
Secondary outcomes:
- To determine whether the use of HPI leads to better maternal outcomes (incidence of nausea and vomiting, blood loss, length of hospital stay, maternal satisfaction, incidence of surgical site infection)
- To determine whether the use of HPI leads to better foetal outcomes (Apgar scores, umbilical cord pH, length of hospital stay)
- To determine the amount of vasopressors and inotropes administered throughout CS if HPI is used versus conventional oNIBP monitoring
RESEARCH HYPOTHESIS
Additional parameters from HPI in the CS under spinal anaesthesia will reduce the duration and severity of intraoperative hypotension and provide better maternal and neonatal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, double-blinded, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: HPI Group | Experimental | Device: Hypotension prediction indexThere were 2 arm group, in Group 1the Acumen IQ cuff, with HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon. |
| Group 2: NIBP Group | Placebo comparator | Device: Non invasive Blood Pressure Monitoringthe attending anaesthetist will be blinded from the HPI parameters. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ≥ 37 weeks of gestation
- Elective CS
- Age between 18 - 40 years old
- Singleton pregnancy
- Planned for spinal anaesthesia
Key exclusion criteria (12 listed)
- American Society of Anesthesiologists (ASA) III and above
- Body mass index (BMI) ≥ 40 kg/m2
- Increased risk of developing peripartum haemorrhage
- History of peripartum haemorrhage
- Placenta previa major, accrete, increta, percreta
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 |
|---|---|---|
| Hypotension prediction indexAlso: HPIHPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon | Device | Group 1: HPI Group |
| Non invasive Blood Pressure MonitoringAlso: NIBPAnaesthetist will respond to hemodynamic variables using NIBP | Device | Group 2: NIBP Group |
Primary outcome
Time-weighted average of Mean arterial pressure <65mmHg
Time frame: From spinal anaesthesia to completion of surgery
Calculated using a formula. TWA-MAP < 65 mmHg = (the depth of hypotension< MAP of 65 mmHg x time spent below a MAP of 65 mmHg (minutes))/(total duration of operation (minutes))
7 secondary outcomes
Incidence of nausea and vomiting,
Time frame: Perioperative up to 2 days
length of hospital stay
Time frame: Perioperative up to 2 weeks
maternal satisfaction
Time frame: Perioperative up to 2 weeks
incidence of surgical site infection
Time frame: Perioperative up to 2 weeks
Apgar score of feotal
Time frame: 1 minute and 5 minutes after delivery
Umbilical cord PH
Time frame: Immediately upon delivery of baby
Neonatal length of stay
Time frame: Perioperative up to 2 weeks
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 17 Jun 2026.
- Background: PubMed 35054083Murabito P, Astuto M, Sanfilippo F, La Via L, Vasile F, Basile F, Cappellani A, Longhitano L, Distefano A, Li Volti G. Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial. J Clin Med. 2022 Jan 13;11(2):392. doi: 10.3390/jcm11020392.
- Background: PubMed 26181335Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
- Background: PubMed 34591796Frassanito L, Sonnino C, Piersanti A, Zanfini BA, Catarci S, Giuri PP, Scorzoni M, Gonnella GL, Antonelli M, Draisci G. Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia. Anesth Analg. 2022 Mar 1;134(3):633-643. doi: 10.1213/ANE.0000000000005754.
- Background: PubMed 37510686Andrzejewska A, Miegon J, Zacha S, Skonieczna-Zydecka K, Jarosz K, Zacha W, Biernawska J. The Impact of Intraoperative Haemodynamic Monitoring, Prediction of Hypotension and Goal-Directed Therapy on the Outcomes of Patients Treated with Posterior Fusion Due to Adolescent Idiopathic Scoliosis. J Clin Med. 2023 Jul 9;12(14):4571. doi: 10.3390/jcm12144571.
- Individual participant dataSharing planned: Yes. The data of the study will be available in public data repository
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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.
Azlina Masdar principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotension prediction index and Non invasive Blood Pressure Monitoring in people with Pregnancy Related and Hypotension, run by National University of Malaysia at 1 site in Malaysia.
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 12 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 17 Jun 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Time-weighted average of Mean arterial pressure <65mmHg (time frame: From spinal anaesthesia to completion of surgery). 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 NCT06892665, which also lists 4 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 17 Jun 2026.