Active — Not RecruitingNot Applicable

Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

Singapore173 participantsStarted 2018-11-07

Plain-language summary

Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.

Who can participate

Age range21 Years – 50 Years

SexFEMALE

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: * Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients; * With singleton full-term pregnancy; * The indication for an elective cesarean delivery; * The use of spinal anaesthesia for cesarean delivery; * Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm. Exclusion Criteria: * Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications; * Contraindication to spinal anaesthesia and/or allergy to opioids.

What they're measuring

Number of events of Hypotension occurrence

Timeframe: 1 day (during cesarean delivery)

Trial details

NCT IDNCT03620942

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Hypotension trials