Cesarean Section ComplicationsNCT05933993
Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
An observational study of Cesarean Section Complications, run by Sygehus Lillebaelt at 2 sites in Denmark.
Trial summary
Background and aim: In Denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. Half of these cesarean sections are elective. Previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Elective cesarean section
- How many people
- 27 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Sep 2023to 20 Nov 2023
- 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: All adult women undergoing an elective cesarean section in one of the three participating hospitals are eligible for inclusion.
Who may be able to join
- women undergoing an elective cesarean section under spinal anesthesia
- speaking/writing Danish
Who cannot join
- cesarean section performed under general anesthesia
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
North Zealand Hospital, Hillerød
Hillerød, 3400
About this study
Background and aim:
In Denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. Half of these cesarean sections are elective. Previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to care for their baby and recover.
Read more
The Danish national anesthesiological research network, CEPRA (Collaboration for Evidence based Practice and Research in Anesthesia) is planning a national study on pain following elective cesarean sections. In order to assure that the investigators will be using actual patient-relevant outcomes in this large national study, the aim with this qualitative study is to obtain knowledge on how Danish women experience pain, recovery and function following an elective cesarean section.
Methods:
This is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section.
The study will take place in three Danish hospitals (Kolding, Copenhagen and Hillerød).
Women aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion.
Women will be informed about the study, orally and in writing, at the pre-anesthesiological consultation, which is held a few days before the cesarean section. Participation is completely voluntary. If they to participate, participants will sign a consent form. The investigators will include and interview participants until data saturation occurs. It is expected that 20-30 women should be included in total, evenly distributed at the three participating hospitals.
Interviews will be held by telephone, recorded digitally and transscribed verbatim. Transscribed interviews will be coded for categories and themes using the NVivo software. Data will be analysed using manifest content analysis.
Baseline characteristics will be handled with descriptive statistics.
The primary outcome of the study is a thematic analysis of Danish womens experience of pain, recovery and function following an elective cesarean section.
- Conditions
- Cesarean Section Complications
- Being tested
- Elective cesarean section
- Keywords
- postoperative pain, postoperative function, patient-relevant outcomes
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective cesarean sectionOther
The study does not contain an intervention in itself, but women are included if they undergo an elective cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Mothers, following an elective cesarean sections | The cohort in this study consists of Danish mothers, undergoing an elective cesarean section in one og the three participating hospitals. Receives: Other: Elective cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The primary outcome of the study is a thematic analysis of Danish womens experience of pain following an elective cesarean section. As the study is qualitative, no scale will be used to measure pain, but instead the experience of pain as described by the participants.
Measured: 4 to 7 days after the elective cesarean section
Secondary outcomes (2)
Recovery
A secondary outcome of the study is a thematic analysis of Danish womens experience of recovery following an elective cesarean section. As the study is qualitative, no scale will be used, but instead the experience of recovery following cesarean section, as described by the participants
Measured: 4 to 7 days after the elective cesarean section
Physical function
A secondary outcome of the study is a thematic analysis of Danish womens experience of physical function following an elective cesarean section. As the study is qualitative, no scale will be used, but instead the experience of physical function following cesarean section, as described by the participants
Measured: 4 to 7 days after the elective cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start20 Sep 2023
- Primary completion10 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark, Nordsjaellands Hospital
- Responsible party
- Principal investigator, Helene Korvenius Nedergaard, Sygehus Lillebaelt
- Investigators
- Helene K Nedergaard, Principal investigator, Lillebaelt Hospital Kolding, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933993
- Sponsor's protocol ID
- 979809337
- Status last verified
- Apr 2024
- First submitted
- 21 Jun 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
- ClinicalTrials.gov ID
- NCT05933993
- Acronym / sponsor ID
- 979809337
- Conditions
- Cesarean Section Complications
- Keywords
- postoperative pain, postoperative function, patient-relevant outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark, Nordsjaellands Hospital
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 6 Jul 2023 (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 and aim:
In Denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. Half of these cesarean sections are elective. Previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to care for their baby and recover.
The Danish national anesthesiological research network, CEPRA (Collaboration for Evidence based Practice and Research in Anesthesia) is planning a national study on pain following elective cesarean sections. In order to assure that the investigators will be using actual patient-relevant outcomes in this large national study, the aim with this qualitative study is to obtain knowledge on how Danish women experience pain, recovery and function following an elective cesarean section.
Methods:
This is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section.
The study will take place in three Danish hospitals (Kolding, Copenhagen and Hillerød).
Women aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion.
Women will be informed about the study, orally and in writing, at the pre-anesthesiological consultation, which is held a few days before the cesarean section. Participation is completely voluntary. If they to participate, participants will sign a consent form. The investigators will include and interview participants until data saturation occurs. It is expected that 20-30 women should be included in total, evenly distributed at the three participating hospitals.
Interviews will be held by telephone, recorded digitally and transscribed verbatim. Transscribed interviews will be coded for categories and themes using the NVivo software. Data will be analysed using manifest content analysis.
Baseline characteristics will be handled with descriptive statistics.
The primary outcome of the study is a thematic analysis of Danish womens experience of pain, recovery and function following an elective cesarean section.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers, following an elective cesarean sections | – | Other: Elective cesarean sectionThe cohort in this study consists of Danish mothers, undergoing an elective cesarean section in one og the three participating hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult women undergoing an elective cesarean section in one of the three participating hospitals are eligible for inclusion.
Key inclusion criteria (2 listed)
- women undergoing an elective cesarean section under spinal anesthesia
- speaking/writing Danish
Key exclusion criteria (1 listed)
- cesarean section performed under general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective cesarean sectionThe study does not contain an intervention in itself, but women are included if they undergo an elective cesarean section | Other | Mothers, following an elective cesarean sections |
Primary outcome
Pain
Time frame: 4 to 7 days after the elective cesarean section
The primary outcome of the study is a thematic analysis of Danish womens experience of pain following an elective cesarean section. As the study is qualitative, no scale will be used to measure pain, but instead the experience of pain as described by the participants.
2 secondary outcomes
Recovery
Time frame: 4 to 7 days after the elective cesarean section
Physical function
Time frame: 4 to 7 days after the elective cesarean section
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 26 Apr 2024.
- CEPRA, Collaboration for Evidence-based Practice and Research in AnesthesiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Helene K Nedergaard principal investigator
Lillebaelt Hospital Kolding, Department of Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Sygehus Lillebaelt at 2 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Pain (time frame: 4 to 7 days after the elective cesarean section). 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 26 Apr 2024.