Pain Management in Pregnant WomenNCT07030777
The Experience of Giving Birth With Remifentanil for Pain Relief: A Qualitative Study of Mothers and Midwives
An observational study of Pain Management in Pregnant Women and Remifentanil, run by Nordsjaellands Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management in Pregnant Women, Remifentanil, Midwife
- How many people
- 40 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Mar 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 1)Women in labor who do not speak Danish or English.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
University Hospital of Copenhagen, North Zealand Hospital
Hillerød, Select State, 3400
Department of Anaesthesia and Intensive care, University Hospital of Southern Denmark, Kolding, Denmark
Kolding
Præhospital center
Næstved
About this study
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.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time Frame: Interviews conducted within 4-10 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Mar 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management in Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Duch, Nordsjaellands Hospital
- Investigators
- Patricia Duch, MD, Study chair, Department of Anaesthesia, Copenhagen University Hospital, North Zealand, Hillerød, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030777
- Sponsor's protocol ID
- 103
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD Sharing Statement Individual participant data (IPD) in the form of full interview transcripts will not be shared due to privacy concerns and the qualitative, sensitive nature of the material. However, de-identified quotes and aggregated thematic analysis results may be shared as part of the published findings or upon reasonable request for academic purposes, in accordance with participants' consent and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Giving Birth With Remifentanil for Pain Relief: A Qualitative Study of Mothers and Midwives
- ClinicalTrials.gov ID
- NCT07030777
- Acronym / sponsor ID
- 103
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1)Women in labor who do not speak Danish or English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD Sharing Statement Individual participant data (IPD) in the form of full interview transcripts will not be shared due to privacy concerns and the qualitative, sensitive nature of the material. However, de-identified quotes and aggregated thematic analysis results may be shared as part of the published findings or upon reasonable request for academic purposes, in accordance with participants' consent and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Duch, MD study chair
Department of Anaesthesia, Copenhagen University Hospital, North Zealand, Hillerød, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management in Pregnant Women and Remifentanil, run by Nordsjaellands Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiential understanding of remifentanil-assisted labor from the perspectives of mothers (time frame: Interviews conducted within 4-10 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.