Outpatient CareNCT01921465
Outpatient Care for Multiparas After Elective Cesarean Section: an Observational Study
An observational study of Outpatient Care, run by Herning Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to evaluate whether outpatient cesarean section can be performed in multiparous women without significant decrease in the parents' sense of security . Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Outpatient Care
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Jun 2014
- How long will I take part?
- 4 Months
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: multiparas having a elective cesarean section 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
- Internet access at home
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.
Denmark1 site
Department of gynaecology and obstetrics, Herning Hospital
Herning, Herning, 7400
About this study
The purpose of the study is to evaluate whether outpatient cesarean section can be performed in multiparous women without significant decrease in the parents' sense of security .
- Conditions
- Outpatient Care
- Keywords
- outpatient care, videoconferencing, elective cesarean section
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 having a planned cesarean section | elective cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
the parents' postnatal sense of security (PPSS)
measured by a questionnaire sent to the parents' in the second week after delivery.
Measured: the PPSS is measured the second week after delivery
Secondary outcomes (1)
ambulation time
ambulation time measured during the first three days after delivery by an accelerometer
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJun 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 Outpatient CareStudies 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
- 20 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Iben Lorentzen, Herning Hospital
- Investigators
- Iben P Lorentzen, Midwife, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921465
- Sponsor's protocol ID
- 1ILorentzen
- Other IDs
- outpatientcesareanlorentzen
- Status last verified
- Feb 2014
- First submitted
- 9 Aug 2013
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Care for Multiparas After Elective Cesarean Section: an Observational Study
- ClinicalTrials.gov ID
- NCT01921465
- Acronym / sponsor ID
- 1ILorentzen
- Conditions
- Outpatient Care
- Keywords
- outpatient care, videoconferencing, elective cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- 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 purpose of the study is to evaluate whether outpatient cesarean section can be performed in multiparous women without significant decrease in the parents' sense of security .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multiparas having a planned cesarean section | – | –elective cesarean section |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- multiparas having a elective cesarean section at Herning hospital
Key inclusion criteria (5 listed)
- Planned elective cesarean section of multiparous women
- Singleton pregnancy
- Age of at least 18
- Gestational age between 37 and 42 weeks
- Internet access at home
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
the parents' postnatal sense of security (PPSS)
Time frame: the PPSS is measured the second week after delivery
measured by a questionnaire sent to the parents' in the second week after delivery.
1 secondary outcome
ambulation time
Time frame: three days
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 18 Aug 2016.
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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
University of Aarhus
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 Outpatient Care, 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 5 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 18 Aug 2016. 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?
the parents' postnatal sense of security (PPSS) (time frame: the PPSS is measured the second week after delivery). 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 18 Aug 2016.