Continuous Remote Vital Sign Monitoring During Labour Analgesia With Remifentanil

ConditionLabor Pain

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-50

SponsorNordsjaellands Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Minimum 18 years of age

Able to provide written informed consent

Giving birth to a singleton, cephalic presenting, expected healthy child, gestational age > 37 weeks.

In active labour

Disqualifiers

Respiratory or cardiac disease

BMI ≥ 40 Other opioids within the last 4 hours.

Trial population

The study will be conducted at the labour ward of North Zealand Hospital. All parturients who meet the eligibility criteria may be included, provided that qualified staff are available at the time of admission.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Intermittent midwife absence during remote monitoring of remifentanil PCA in labour
Behavioral
Midwife absence during remifentanil PCA for labour analgesia. We aim to include a total of 80 participants. All will receive remifentanil PCA for labour analgesia and be monitored with remote monitoring equipment. First a group of 40 parturients will be included, and the attending midwife will not be allowed to leave the parturient (Group 1). A following group of 40 parturients will then be included and the attending midwife can leave the room in intervals up to 10 minutes (Group 2).

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Group 1: The midwife stays in the labour room during remifentanil PCA for labour analgesia1 intervention

Group B: Group 2: The midwife can leave the labour room during remifentanil PCA for labour analgesia1 intervention