Can a smart pump outperform manual care for blood pressure in C-Sections?
NCT ID NCT04025918
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests an automated system that monitors blood pressure continuously and automatically delivers two medications to prevent low blood pressure during cesarean sections under spinal anesthesia. The system is compared to the standard manual approach of giving bolus doses. The study includes women aged 21-45 undergoing C-sections, and measures how often blood pressure drops below a safe threshold, as well as the occurrence of high blood pressure and nausea.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- An automated closed-loop system that monitors blood pressure and delivers phenylephrine and ephedrine via syringe pumps to prevent hypotension during C-sections.
- What this could lead to
- If effective, this automated system could offer a more precise and timely way to manage blood pressure during C-sections, potentially reducing risks for mothers and babies.
- What could go wrong
- This is a mid-stage trial, so the system may not prove more effective than manual methods. There are also risks of over- or under-treatment, which could lead to hypertension or persistent hypotension.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
216 people
The number who actually took part.
- Started
-
Oct 2011
- Finished
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Jul 2012
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 45 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * age 21-45 years old, * weight 40-90 kg, * height 145-170 cm Exclusion Criteria: * contraindications to spinal anaesthesia, * allergy to drugs used in the study, and * those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smart pump prevent dangerous drops in blood pressure during C-Sections?