NCT06892665 The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections
| NCT ID | NCT06892665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Malaysia |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-01-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion criteria: * ≥ 37 weeks of gestation * Elective CS * Age between 18 - 40 years old * Singleton pregnancy * Planned for spinal anaesthesia Exclusion criteria: * 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 * 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
Contact & Investigator
Azlina Masdar
PRINCIPAL INVESTIGATOR
National University of Malaysia
Frequently Asked Questions
Who can join the NCT06892665 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06892665 currently recruiting?
Yes, NCT06892665 is actively recruiting participants. Contact the research team at syarifahnazihah@yahoo.com.my for enrollment information.
Where is the NCT06892665 trial being conducted?
This trial is being conducted at Cheras, Malaysia.
Who is sponsoring the NCT06892665 clinical trial?
NCT06892665 is sponsored by National University of Malaysia. The principal investigator is Azlina Masdar at National University of Malaysia. The trial plans to enroll 100 participants.