The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections (NCT06892665) | Clinical Trial Compass
CompletedNot Applicable
The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections
Malaysia100 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time-weighted average of Mean arterial pressure <65mmHg
Timeframe: From spinal anaesthesia to completion of surgery