Postoperative PeriodNCT02911727
Fast-track Discharge After Elective Cesarean Section
A study testing Fast-track discharge in people with Postoperative Period, run by Herning Hospital at 1 site in Denmark.
Trial summary
Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Period
- What is being tested?
- Fast-track discharge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to 31 May 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned elective CS of multiparous women
- Singleton pregnancy
- Gestational age at least 37+0 weeks
- Prepregnancy BMI <35
Who cannot join
- Lack of consent
- Women with no or little understanding of and ability to speak Danish
- Expected maternal or neonatal complications after delivery
Trial locations and contacts
1 site in 1 country.
About this study
Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.
The aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.
Read more
The study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.
This study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.
- Conditions
- Postoperative Period
- Being tested
- Fast-track discharge
- Keywords
- Cesarean section, Postnatal Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-track dischargeProcedure or surgery
As described above
| Study group | Role | What they receive |
|---|---|---|
| Fast-track discharge | Experimental | Intention to discharge within 28 hours after elective cesarean section including a home visit by a nurse or midwife from the postnatal ward. Receives: Procedure: Fast-track discharge |
| Standard discharge | No intervention | Discharge at least 48 hours after elective cesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' Postnatal Sense of Security
Using the validated PPSS-questionaire
Measured: Measured one week after delivery
Secondary outcomes (8)
Pain scores
Measured by the patient in a questionnaire using numeric rating scale
Measured: During the first week postpartum
Use of analgesia
Daily consumption in mg of paracetamol, NSAID and opioid.
Measured: During the first week postpartum
Mobilization
Step count measured by an activity monitor (Fitbit Flex)
Measured: 5 days postpartum
Breastfeeding
Duration and extent of breastfeeding
Measured: 6 months after delivery
Readmissions
Number of readmissions and length of hospital stay in number of days
Measured: 28 days postpartum
Surgical complications
Number of complications using the Clavien-Dindo Classification (1-5)
Measured: 28 days postpartum
Complications in the postnatal period
Number and type of complications using the ICD-10 classification
Measured: 28 days postpartum
Contacts to the health care system
Number of contacts and site of contacts (primary or secondary care)
Measured: 28 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 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion31 Dec 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PeriodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kruse, Herning Hospital
- Investigators
- Byrjalsen, MD, Study chair, Department chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911727
- Sponsor's protocol ID
- 1
- Status last verified
- May 2020
- First submitted
- 2 Sep 2016
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jones E, Stewart F, Taylor B, Davis PG, Brown SJ. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2021 Jun 8;6(6):CD002958. doi: 10.1002/14651858.CD002958.pub2.
PubMed 34100558
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Discharge After Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT02911727
- Acronym / sponsor ID
- 1
- Conditions
- Postoperative Period
- Keywords
- Cesarean section, Postnatal Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Sep 2016 (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.
Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.
The aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.
The study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.
This study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track discharge | Experimental | Procedure: Fast-track dischargeIntention to discharge within 28 hours after elective cesarean section including a home visit by a nurse or midwife from the postnatal ward. |
| Standard discharge | No intervention | –Discharge at least 48 hours after elective cesarean section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned elective CS of multiparous women
- Singleton pregnancy
- Gestational age at least 37+0 weeks
- Prepregnancy BMI <35
Key exclusion criteria (3 listed)
- Lack of consent
- Women with no or little understanding of and ability to speak Danish
- Expected maternal or neonatal complications after delivery
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 |
|---|---|---|
| Fast-track dischargeAs described above | Procedure or surgery | Fast-track discharge |
Primary outcome
Parents' Postnatal Sense of Security
Time frame: Measured one week after delivery
Using the validated PPSS-questionaire
8 secondary outcomes
Pain scores
Time frame: During the first week postpartum
Use of analgesia
Time frame: During the first week postpartum
Mobilization
Time frame: 5 days postpartum
Breastfeeding
Time frame: 6 months after delivery
Readmissions
Time frame: 28 days postpartum
Surgical complications
Time frame: 28 days postpartum
Complications in the postnatal period
Time frame: 28 days postpartum
Contacts to the health care system
Time frame: 28 days postpartum
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 2 Jun 2020.
- Derived from this study: PubMed 34100558Jones E, Stewart F, Taylor B, Davis PG, Brown SJ. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2021 Jun 8;6(6):CD002958. doi: 10.1002/14651858.CD002958.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Period
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruiting
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
Single-level Lumbar Arthrodesis
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
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.
Byrjalsen, MD study chair
Department chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-track discharge in people with Postoperative Period, 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 3 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 2 Jun 2020. 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?
Parents' Postnatal Sense of Security (time frame: Measured one week after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02911727, which also lists 1 linked publication.
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 2 Jun 2020.