Cesarean Section ComplicationsNCT05396417
How Well do the Current Cesarean Deliveries Adhere to the Published ERAS Guidelines?
An observational study of Cesarean Section Complications, run by Women's Hospital HUS at 1 site in Finland.
Trial summary
Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- cesarean delivery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2023to 31 Jul 2023
- How long will I take part?
- 3 Days
- 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 55 years
- Women only
- Adult
Study population: Women undergoing cesarean delivery at the University of Helsinki central hospital/Women's hospital
Who may be able to join
- Eligible for ERAS protocol cesarean delivery
- Cesarean delivery for any indication
- Any anesthesia method
- Any urgency category
Who cannot join
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Recovery After Surgery for Patients Undergoing Cesarean Delivery; Adherence to the Institutional Guideline
Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local check-list for cesarean delivery.
Read the detailed description
The study will produce a snapshot of the current state of treatment in the third largest delivery hospital in Europe. The study will include cesarean deliveries in all urgency categories.
The data will be collected prospectively by enrolling parturients in consecutive order from the study start date. The data will be collected in the form of a paper check list that is to be filled up by the nursing staff and doctors who are taking care of the parturient through her stay at the hospital.
- Conditions
- Cesarean Section Complications
- Being tested
- cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean deliveryProcedure or surgery
Cesarean delivery under any form of anesthesia for any reason and for any indication
| Study group | Role | What they receive |
|---|---|---|
| Cesarean delivery | Any urgency any reason Receives: Procedure: cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of adherence to the ERAS guidelines after elective or emergency cesarean delivery
To which extent does the postoperative treatment of the parturients meet the ERAS criteria
Measured: 3 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jan 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
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
- 500 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Women's Hospital HUS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antti Vaananen, Women's Hospital HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396417
- Sponsor's protocol ID
- Tutkimussuunnitelma25032022_I
- Status last verified
- Apr 2023
- First submitted
- 27 May 2022
- Last updated
- 26 Apr 2023
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recovery After Surgery for Patients Undergoing Cesarean Delivery; Adherence to the Institutional Guideline
- ClinicalTrials.gov ID
- NCT05396417
- Acronym / sponsor ID
- Tutkimussuunnitelma25032022_I
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Women's Hospital HUSUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 31 May 2022 (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.
Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local check-list for cesarean delivery.
Detailed description
The study will produce a snapshot of the current state of treatment in the third largest delivery hospital in Europe. The study will include cesarean deliveries in all urgency categories.
The data will be collected prospectively by enrolling parturients in consecutive order from the study start date. The data will be collected in the form of a paper check list that is to be filled up by the nursing staff and doctors who are taking care of the parturient through her stay at the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean delivery | – | Procedure: cesarean deliveryAny urgency any reason |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women undergoing cesarean delivery at the University of Helsinki central hospital/Women's hospital
Key inclusion criteria (4 listed)
- Eligible for ERAS protocol cesarean delivery
- Cesarean delivery for any indication
- Any anesthesia method
- Any urgency category
Key exclusion criteria (1 listed)
- Age under 18 years
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 |
|---|---|---|
| cesarean deliveryCesarean delivery under any form of anesthesia for any reason and for any indication | Procedure or surgery | Cesarean delivery |
Primary outcome
Level of adherence to the ERAS guidelines after elective or emergency cesarean delivery
Time frame: 3 days post surgery
To which extent does the postoperative treatment of the parturients meet the ERAS criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cesarean Section Complications, run by Women's Hospital HUS at 1 site in Finland.
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 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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 Finland. 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?
Results are not available in the source record.
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?
Level of adherence to the ERAS guidelines after elective or emergency cesarean delivery (time frame: 3 days post surgery). 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 2023.