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

NCT ID: NCT07030777

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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 semi-structured interviews with women who gave birth using remifentanil and the midwives involved in their care. The analysis will be a thematic content analysis. All Danish or English speaking labouring women and midwifes at North Zealand hospital giving birth/attending birth with remifentanil for labour pain are eligible to be included during the study period. After written consent the interview will be conducted 4-10 days after the birth.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1)Women in labor who do not speak Danish or English.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patricia Duch

M.D. Consultant, obstetric anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Duch, MD

Role: STUDY_CHAIR

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

Locations

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University Hospital of Copenhagen, North Zealand Hospital

Hillerød, Select State, Denmark

Site Status RECRUITING

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

Kolding, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Præhospital center

Næstved, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Countries

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Denmark

Central Contacts

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Patricia Duch, MD

Role: CONTACT

+45 48292504

Laura Fugmann, Midwife

Role: CONTACT

Facility Contacts

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Patricia Duch, MD

Role: primary

0045 49282504

Laura Fugmann, Midwife

Role: backup

Other Identifiers

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103

Identifier Type: -

Identifier Source: org_study_id

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