Continuous Remote Vital Sign Monitoring During Labour Analgesia With Remifentanil

NCT07167498 | Not Yet Recruiting DMC

• 1 other identifier: 104
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

remifentanil; labour analgesia; remote monitoring; safety

Outcome Measures

Primary Outcomes (1)

• Incidence of SpO₂ 90-93% lasting more than 2 minutes

  During the use of remifentanil for labour analgesia.

  During labour

Secondary Outcomes (4)

• Incidence of SpO2 89-85% lasting more than one minute

  During labour

• Any incidence of SpO2 < 85%

  During labour

• Incidence of RR < 9 for ≥5 minutes

  During labour

• Incidence of neonates with Apgar score < 7

  measured 5 minutes after birth

Other Outcomes (7)

• Incidence of parturient being unconscious assessed by AVPU assessment scale (Alert, Voice, Pain, Unresponsive) during the use of remifentanil for labour analgesia.

  During the use of remifentanil for labour analgesia.

• Incidence of HR < 50

  During the use of remifentanil for labour analgesia.

• Incidence of RR ≤5

  During the use of remifentanil for labour analgesia.

Study Arms (2)

Group 1: The midwife stays in the labour room during remifentanil PCA for labour analgesia

Group 1: The midwife stays in the labour room while the parturient are having remifentanil for labour analgesia.

Behavioral: Intermittent midwife absence during remote monitoring of remifentanil PCA in labour

Group 2: The midwife can leave the labour room during remifentanil PCA for labour analgesia

Group 2: the midwife is permitted to leave the labour room for intervals of up to 10 minutes while carrying a personal handheld device that displays continuous SpO₂, respiratory rate, and heart rate for remote monitoring.

Behavioral: Intermittent midwife absence during remote monitoring of remifentanil PCA in labour

Interventions

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).

Group 1: The midwife stays in the labour room during remifentanil PCA for labour analgesia; Group 2: The midwife can leave the labour room during remifentanil PCA for labour analgesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Respiratory or cardiac disease
• BMI ≥ 40 Other opioids within the last 4 hours.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

University Hospital of Copenhagen, Northern Zealand

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Duch, MD

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Duch, MD

CONTACT

+45 48292504; Patricia.duch@regionh.dk

Laura Fugmann, Cand. Soc

CONTACT

Laura.Fugmann@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 11, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)