Postpartum ComplicationNCT05024370
Multiparas Attitude to Outpatient Cesarean Section
An observational study of Postpartum Complication, run by Herning Hospital at 1 site in Denmark.
Trial summary
The main purpose of this study is to explore multiparas attitude to outpatient care after a planned cesarean section. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Complication
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Jun 2014
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mulitparas having a planned cesarean section at the department of Obstetrics and Gynecology at Herning Hospital
Who may be able to join
- Planned elective cesarean section of multiparous women
- Singleton pregnancy
- Age of at least 18
- Gestational age between 37 and 42 weeks
Who cannot join
- Lack of consent
- Women with no or little understanding of Danish and ability to speak Danish.
- Allergies to medicine included in the pain management regimes
- Expected maternal or neonatal complications after delivery
- Birth weight of less than 2500 grams
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiparas Attitude to Outpatient Care After Cesarean Section - A Qualitative Study
The main purpose of this study is to explore multiparas attitude to outpatient care after a planned cesarean section.
Read the detailed description
This qualitative study should provide information about:
- Multiparas reflections in relation to prefer inpatient care after a planned cesarean section
- Womens anticipation of having inpatient care after cesarean section
- The womens experiences in relation to a planned cesarean birth and the first postnatal weeks
- Conditions
- Postpartum Complication
- Keywords
- qualitative, planned cesarean section, outpatient care, Multiparas attitude
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 |
|---|---|---|
| Multiparas, planned cesarean section | Multiparas having a planned cesarean section at the departement of Obstetrics and Gynecology in Herning Hospital. Uncomplicated pregnancy that makes early discharge possible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
womens attitude an reflections about based on interviews
Measured: october 2013- june 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study startNov 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ComplicationStudies 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
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iben Lorentzen, Herning Hospital
- Investigators
- Iben P Lorentzen, Midwife, Principal investigator, Department of Obstetrics and Gynecology, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024370
- Sponsor's protocol ID
- outpatientcesareanQual
- Status last verified
- Aug 2021
- First submitted
- 24 Feb 2014
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparas Attitude to Outpatient Care After Cesarean Section - A Qualitative Study
- ClinicalTrials.gov ID
- NCT05024370
- Acronym / sponsor ID
- outpatientcesareanQual
- Conditions
- Postpartum Complication
- Keywords
- qualitative, planned cesarean section, outpatient care, Multiparas attitude
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Aug 2021 (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.
The main purpose of this study is to explore multiparas attitude to outpatient care after a planned cesarean section.
Detailed description
This qualitative study should provide information about:
- Multiparas reflections in relation to prefer inpatient care after a planned cesarean section
- Womens anticipation of having inpatient care after cesarean section
- The womens experiences in relation to a planned cesarean birth and the first postnatal weeks
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiparas, planned cesarean section | – | –Multiparas having a planned cesarean section at the departement of Obstetrics and Gynecology in Herning Hospital. Uncomplicated pregnancy that makes early discharge possible. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mulitparas having a planned cesarean section at the department of Obstetrics and Gynecology at Herning Hospital
Key inclusion criteria (4 listed)
- Planned elective cesarean section of multiparous women
- Singleton pregnancy
- Age of at least 18
- Gestational age between 37 and 42 weeks
Key exclusion criteria (5 listed)
- Lack of consent
- Women with no or little understanding of Danish and ability to speak Danish.
- Allergies to medicine included in the pain management regimes
- Expected maternal or neonatal complications after delivery
- Birth weight of less than 2500 grams
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
womens attitude an reflections about based on interviews
Time frame: october 2013- june 2014
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 27 Aug 2021.
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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.
Iben P Lorentzen, Midwife principal investigator
Department of Obstetrics and Gynecology, Herning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Complication, run by Herning Hospital at 1 site 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 4 inclusion and 5 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
womens attitude an reflections about based on interviews (time frame: october 2013- june 2014). 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 27 Aug 2021.