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Continuous Remote Vital Sign Monitoring During Labour Analgesia With Remifentanil

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Dec 30, 2026 to Dec 30, 2027
    • Start date: Nov 1, 2025 to Nov 1, 2026
    • Study completion date: Jun 30, 2027 to Jun 30, 2028
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Continuous remote vital sign monitoring during labour analgesia with remifentanil - a prospective observational study Remifentanil PCA represents a well-tolerated, effective and valuable option for labour analgesia, yet its wider implementation is still limited by concerns of opioid side-effects particularly the risk of respiratory depression leading to desaturation, potentially affecting the foetus. Thus, continuous one-to-one observation and monitoring in the delivery room, with the midwife unable to leave the patient unattended, is recommended. Such constant one-to-one monitoring may be challenging in present health-care settings where staffing constraints may limit the implementation of remifentanil as routine obstetric care. Continuous remote vital sign monitoring to display oxygen saturation (SpO₂), respiratory rate, and heart rate on a handheld device (smartphone), has the potential to address this barrier by allowing the midwife to leave the labour room for short, predefined intervals while maintaining continuous surveillance of maternal vital signs. Such an approach could free staff resources without compromising patient safety. While centralised foetal monitoring (CTG) is standard practice in many units, the application of continuous remote vital sign monitoring for women receiving remifentanil during labour has, to our knowledge, never been formally studied. Objectives The aim is to study whether remote monitoring during remifentanil patient-controlled analgesia (PCA) for labour affects the incidence of maternal desaturation and other safety outcomes (bradypnoea, bradycardia, and neonatal outcomes, assessed via Apgar scores and umbilical cord pH.) The study will be conducted in a setting where remifentanil PCA is administered for labour analgesia and the midwife is permitted to leave the labour room for intervals of up to 10 minutes while the woman is remotely monitored using a handheld device carried by the midwife. Predefined criteria for when the woman must be accompanied (e.g., if SpO₂ \< 94%, supplemental oxygen \>2L/min., or decreased consciousness). Outcomes in this group will be compared with a control group where the midwife remains continuously present in the labour room.
Trial Details
NCT Number NCT07167498
Lead Sponsor Nordsjaellands Hospital
Conditions
(from sponsor)
Labor Pain
Related terms Labor Pain
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov