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Clinical Trials/NCT07030777
NCT07030777RecruitingNot Applicable

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

Nordsjaellands Hospital3 sites in 1 country40 target enrollmentStarted: March 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
3
Primary Endpoint
Experiential understanding of remifentanil-assisted labor from the perspectives of mothers

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Interviews conducted within 4-10 days postpartum

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.

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

Time Frame: Time Frame: Interviews conducted within 4-10 days postpartum

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nordsjaellands Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Patricia Duch

M.D. Consultant, obstetric anaesthetist

Nordsjaellands Hospital

Study Sites (3)

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