The Experience of Giving Birth With Remifentanil for Pain Relief: A Qualitative Study of Mothers and Midwives

NCT07030777 | Recruiting

• 1 other identifier: 103
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Remifentanil is an ultra-short-acting opioid used for labor pain relief in several countries, offering stronger analgesia than nitrous oxide but less than epidural anesthesia. While internationally established, remifentanil has not yet been implemented in Denmark. Objective: This study aims to explore and deepen our understanding of the childbirth experience with remifentanil for pain relief, from both the birthing woman's and the midwife's perspectives. Methods: A qualitative study based on interviews with women who gave birth using remifentanil and the midwives involved in their care.

Conditions

Pain Management in Pregnant Women; Remifentanil; Midwife; Qualitative Research; Birth; Labour Analgesia

Keywords

Labour analgesia; remifentanil for labour analgesia; qualitative research; midwifes experiences with remifentanil; giving birth with remifentanil

Outcome Measures

Primary Outcomes (2)

• Experiential understanding of remifentanil-assisted labor from the perspectives of mothers

  The co-primary outcome is the in-depth qualitative description of how women experience the use of remifentanil for labor pain relief. The outcome will be derived through thematic analysis of semi-structured interview data, aiming to identify key themes related to pain relief, side-effects, safety, communication, autonomy, and overall birth experience. No quantitative scale will be used.

  Interviews conducted within 4-10 days postpartum

• Experiential understanding of remifentanil-assisted labor from the perspectives of midwives

  Description: The co-primary outcome is the in-depth qualitative description of how midwifes experience the use of remifentanil for labor pain relief. The outcome will be derived through thematic analysis of semi-structured interview data, aiming to identify key themes related to pain relief, side-effects, safety, communication, autonomy, and overall birth experience. No quantitative scale will be used.

  Time Frame: Interviews conducted within 4-10 days postpartum

Study Arms (2)

Midwifes

Group 1: Midwives This group includes licensed midwives who have administered remifentanil for pain relief during labor. Participants will be interviewed about their experiences with providing care during remifentanil-supported childbirth, including perceptions of efficacy, safety, and clinical workflow.

Laboring Women

Group 2: Laboring Women This group consists of women who gave birth using remifentanil patient-controlled analgesia (PCA) for pain relief during labor. Participants will be interviewed about their lived experience of pain management, decision-making, and overall birth experience using remifentanil.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People experiencing labor pain
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population and Recruitment Setting Participants will be initially approached during their hospital admission after giving birth using remifentanil for labor analgesia at the labor ward in Hillerød. At this point, they will receive verbal and written information about the study and may be included if they provide informed consent. Midwives will be contacted after the relevant birth has taken place. They will be informed about the study and included if they agree to participate. If the mother and/or midwife consents to participate, they will be contacted by phone to schedule a semi-structured interview 4-10 days postpartum

You may qualify if:

• Women in labor aged 18 years or older who receive remifentanil for pain relief during childbirth at the labor ward in Hillerød.
• Midwives who participate in childbirths where remifentanil is used as pain relief.

You may not qualify if:

• )Women in labor who do not speak Danish or English.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (3)

University Hospital of Copenhagen, North Zealand Hospital

Hillerød, Select State, 3400, Denmark

RECRUITING

Department of Anaesthesia and Intensive care, University Hospital of Southern Denmark, Kolding, Denmark

Kolding, Denmark

ACTIVE NOT RECRUITING

Præhospital center

Næstved, Denmark

ACTIVE NOT RECRUITING

Study Officials

• Patricia Duch, MD

  Department of Anaesthesia, Copenhagen University Hospital, North Zealand, Hillerød, Denmark

  STUDY CHAIR

Central Study Contacts

Patricia Duch, MD

CONTACT

+45 48292504; Patricia.duch@regionh.dk

Laura Fugmann, Midwife

CONTACT

laura.fugmann@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Consultant, obstetric anaesthetist

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: March 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (3)