Using a device to predict and reduce low blood pressure during cesarean sections
The Effect Of Using Hypotension Prediction Index To Reduce Intraoperative Hypotension In Caesarean Sections: A Randomised Controlled Trial
This study tests whether a new device can help predict and prevent low blood pressure during cesarean sections to keep both mothers and babies safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT06892665 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the Hypotension Prediction Index (HPI) in reducing intraoperative hypotension during elective lower segment cesarean sections. By utilizing a non-invasive blood pressure monitoring device, the HPI aims to predict hypotension before it occurs, allowing for timely intervention. The study will assess both the duration and severity of hypotension, as well as potential complications for both mother and baby. Previous research has shown promising results for HPI in other surgical contexts, suggesting its applicability in obstetric procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 40, at least 37 weeks gestation, undergoing elective cesarean sections with planned spinal anesthesia.
Not a fit: Patients with significant comorbidities, high BMI, or contraindications to the use of the monitoring device may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve maternal and fetal outcomes during cesarean sections by preventing hypotension.
How similar studies have performed: Previous studies have demonstrated the effectiveness of HPI in reducing hypotension in various surgical settings, indicating a strong potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cheras, Kuala Lumpur
- Hospital Canselor Tuanku Muhriz — Cheras, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Azlina Masdar — National University of Malaysia
- Study coordinator: Syarifah Noor Nazihah Sayed Masri
- Email: syarifahnazihah@yahoo.com.my
- Phone: 0133452456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.