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Smart monitor could stop dangerous drops in blood pressure during C-Sections

NCT ID NCT06729827

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new monitoring system that predicts when a mother's blood pressure might drop dangerously during a planned C-section. The device uses a finger cuff to continuously measure blood pressure and an algorithm to warn doctors before a drop occurs. Researchers compared this approach to standard care in 102 women to see if it could reduce the severity and duration of low blood pressure and improve outcomes for both mothers and babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hypotension Prediction Index (HPI) software and norepinephrine bolus
What this could lead to
If successful, this approach could help doctors prevent blood pressure drops during C-sections, reducing side effects like nausea and improving outcomes for mothers and babies.
What could go wrong
This is a small, completed study, so results may not apply to all patients. The device may not work perfectly in every case, and the treatment (norepinephrine) can cause side effects like high blood pressure or slow heart rate.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

102 people

The number who actually took part.

Started

Mar 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: * Full term pregnancy * Elective cesarean section under spinal anesthesia * Age \> 18 years Exclusion Criteria: * refusal to participate to the study * preeclampsia * cardiovascular diseases * neuromuscular disease; * emergent or urgent cesarean delivery; * coagulopathies; * contraindications to spinal anesthesia.

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Conditions

The condition(s) this trial relates to.

pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia complication Cesarean section complications Hypotension on induction Pregnancy related

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, Lazio, 00168, Italy

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