Cesrean DeliveryEracNCT06672198
ERAC Protocol in Elective Cesarean Surgery
An observational study of Cesrean Delivery and Enhanced Recovery After Surgery, run by Gonca Karatas Baran at 1 site in Turkey (Türkiye).
Trial summary
This descriptive prospective study was conducted between 01/12/2021-01/09/2022. The sample of the study consisted of 333 women who underwent elective cesarean section (CS). Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesrean Delivery, Enhanced Recovery After Surgery
- What is being tested?
- ERAC protocol
- Type of treatment
- Surgery or procedure
- How many people
- 333 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Sep 2022
- How long will I take part?
- 10 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: women who had elective CS surgery in the XX hospital
Who may be able to join
- Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery
Who cannot join
- Women who did not have elective CS and did not accept participation in the study are exclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital
Ankara, yenimahalle, 06010
About this study
Official title: "Evaluation of Elective Cesarean Surgery Within the Scope of ERAC Protocol: Where Are We in Türkiye"
This descriptive prospective study was conducted between 01/12/2021-01/09/2022. The sample of the study consisted of 333 women who underwent elective cesarean section (CS). Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. Number, percentage, mean and standard deviation were used as descriptive statistics.
Read the detailed description
A descriptive prospective study was conducted in the Gynecology and Obstetrics branch hospital between 01/12/2021-01/09/2022. The universe of the study consisted of pregnant women who underwent elective CS in the relevant hospital. The study sample consisted of 333 patients who underwent elective CS with the sample calculation method when the universe was known (N: Number of individuals in the population (2500), p: Incidence of the investigated event (0.5), q: Incidence of the examined event (0.5), t: Certain theoretical value found in the "t" table at the degree of freedom and the detected error level (1.96), d: Sensitivity to be made according to the incidence of the event (0.05), 0.95 confidence interval, 0.05 margin of error).
The period of the study group was followed from hospitalization to discharge. The data collection form prepared by scanning the literatüre1-6 was used to collect the research data. The data collection form consisted of two parts. In the first part, there were questions about the socio-demographic and obstetric characteristics of the participant, and in the second part, questions about the components of the ERAC protocol. Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. In the research, data related to health practices were taken from the file and recorded. Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery. Women who did not have elective CS and did not accept participation in the study are exclusion criteria.
Ethics committee approval was obtained from the clinical research ethics committee for the study and informed consent was obtained from the participants.
The analysis of the data was done in computer environment with SPSS (Statistical Package for the Social Sciences) 20.0 ready-made statistical program. In the evaluation of the data; number, percentage, mean and standard deviation were used as descriptive statistics.
- Conditions
- Cesrean Delivery, Enhanced Recovery After Surgery
- Being tested
- ERAC protocol
- Keywords
- Cesarean section, Enhanced recovery after surgery, Perioperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAC protocolProcedure or surgery
our study aimed to evaluate pre-peri-post operative practices in women who underwent elective cesarean section (CS) according to the ERAC protocol. In this context, this study aimed to describe the implementation status of the recommendations regarding the ERAC protocol in CS operations, to identify the missing aspects of the ERAC protocol and to raise awareness about its benefits.
| Study group | Role | What they receive |
|---|---|---|
| cesarean delivery | women undergoing elective caesarean section Receives: Procedure: ERAC protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative applications
Sedative premedication Yes No
Measured: from december 2021 to september 2022
Preoperative information
Preoperative IV fluid ......cc
Measured: from december 2021 to september 2022
Preoperative information ,
Preoperative LMWH aplication Yes No
Measured: from december 2021 to september 2022
Preoperative information
Preoperative antibiotic prophylaxis Yes No
Measured: from december 2021 to september 2022
Preoperative information
Bowel preparation Yes No
Measured: from december 2021 to september 2022
Preoperative information
Skin cleansing with chlorhexidine Yes No
Measured: from december 2021 to september 2022
Preoperative information
ASA classification I, II, III
Measured: from december 2021 to september 2022
Preoperative information
Solid food restriction period (hour)....hour
Measured: from december 2021 to september 2022
Preoperative information
Liquid food restriction period (hour)....hour
Measured: from december 2021 to september 2022
Intraoperative applications
Type of anesthesia General, spinal
Measured: from december 2021 to september 2022
Intraoperative applications
NG cathetere application yes No
Measured: from december 2021 to september 2022
Intraoperative applications
Urinary catheterization application Yes No
Measured: from december 2021 to september 2022
Intraoperative applications
Drain application Yes No
Measured: from december 2021 to september 2022
Intraoperative applications
Epidural analgesia administration Yes No
Measured: from december 2021 to september 2022
Intraoperative applications
Antiemetic agent administration Yes No
Measured: from december 2021 to september 2022
Intraoperative applications
Intraoperative IV fluid amount (cc)......cc
Measured: from december 2021 to september 2022
Intraoperative applications
Incision length (cm).......cm
Measured: from december 2021 to september 2022
Postoperative applications
Nausea Yes No
Measured: from december 2021 to september 2022
Postoperative applications
Heating with a heater Yes No
Measured: from december 2021 to september 2022
Postoperative applications
Pain score (VAS)1-10
Measured: from december 2021 to september 2022
Postoperative applications
Analgesic administration Yes No
Measured: from december 2021 to september 2022
Postoperative applications
Type of analgesic ........
Measured: from december 2021 to september 2022
Postoperative applications
Posoperative LMWH application Yes No
Measured: from december 2021 to september 2022
Postoperative applications
Gum chewing app yes No
Measured: from december 2021 to september 2022
Postoperative applications
Status of providing discharge training Yes No
Measured: from december 2021 to september 2022
Postoperative applications
Information on control Yes No
Measured: from december 2021 to september 2022
Postoperative applications
Principle time breastfeeding (minute).......minute
Measured: from december 2021 to september 2022
Postoperative applications
Time to postoperative gas release (hour)........hour
Measured: from december 2021 to september 2022
Postoperative applications
Time to postoperative stool output (hour).......hour
Measured: from december 2021 to september 2022
Postoperative applications
Time to mobilization (hour)...........hour later
Measured: from december 2021 to september 2022
Postoperative applications
Time to urinary catheter removal (hour)..........hour kater
Measured: from december 2021 to september 2022
Postoperative applications
Time to oral initiation (hour)........hour
Measured: from december 2021 to september 2022
Postoperative applications
Hospitalization time (hour)........hour
Measured: from december 2021 to september 2022
Secondary outcomes (1)
socio-demographic characteristics.
data on socio-demographic characteristics
Measured: from december 2021 to september 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Dec 2021
- Primary completion1 Dec 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesrean DeliveryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Gonca Karatas Baran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gonca Karatas Baran, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- gonca Karataş Baran, phd, Principal investigator, Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672198
- Sponsor's protocol ID
- gkbaran
- Acronym
- Erac
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Elective Cesarean Surgery Within the Scope of ERAC Protocol: Where Are We in Türkiye"
- ClinicalTrials.gov ID
- NCT06672198
- Acronym / sponsor ID
- Erac / gkbaran
- Conditions
- Cesrean Delivery, Enhanced Recovery After Surgery
- Keywords
- Cesarean section, Enhanced recovery after surgery, Perioperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Gonca Karatas BaranUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 4 Nov 2024 (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.
This descriptive prospective study was conducted between 01/12/2021-01/09/2022. The sample of the study consisted of 333 women who underwent elective cesarean section (CS). Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. Number, percentage, mean and standard deviation were used as descriptive statistics.
Detailed description
A descriptive prospective study was conducted in the Gynecology and Obstetrics branch hospital between 01/12/2021-01/09/2022. The universe of the study consisted of pregnant women who underwent elective CS in the relevant hospital. The study sample consisted of 333 patients who underwent elective CS with the sample calculation method when the universe was known (N: Number of individuals in the population (2500), p: Incidence of the investigated event (0.5), q: Incidence of the examined event (0.5), t: Certain theoretical value found in the "t" table at the degree of freedom and the detected error level (1.96), d: Sensitivity to be made according to the incidence of the event (0.05), 0.95 confidence interval, 0.05 margin of error).
The period of the study group was followed from hospitalization to discharge. The data collection form prepared by scanning the literatüre1-6 was used to collect the research data. The data collection form consisted of two parts. In the first part, there were questions about the socio-demographic and obstetric characteristics of the participant, and in the second part, questions about the components of the ERAC protocol. Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. In the research, data related to health practices were taken from the file and recorded. Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery. Women who did not have elective CS and did not accept participation in the study are exclusion criteria.
Ethics committee approval was obtained from the clinical research ethics committee for the study and informed consent was obtained from the participants.
The analysis of the data was done in computer environment with SPSS (Statistical Package for the Social Sciences) 20.0 ready-made statistical program. In the evaluation of the data; number, percentage, mean and standard deviation were used as descriptive statistics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cesarean delivery | – | Procedure: ERAC protocolwomen undergoing elective caesarean section |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women who had elective CS surgery in the XX hospital
Key inclusion criteria (1 listed)
- Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery
Key exclusion criteria (1 listed)
- Women who did not have elective CS and did not accept participation in the study are exclusion criteria
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 |
|---|---|---|
| ERAC protocolour study aimed to evaluate pre-peri-post operative practices in women who underwent elective cesarean section (CS) according to the ERAC protocol. In this context, this study aimed to describe the implementation status of the recommendations regarding the ERAC protocol in CS operations, to identify the missing aspects of the ERAC protocol and to raise awareness about its benefits. | Procedure or surgery | cesarean delivery |
Primary outcome
Preoperative applications
Time frame: from december 2021 to september 2022
Sedative premedication Yes No
Preoperative information
Time frame: from december 2021 to september 2022
Preoperative IV fluid ......cc
Preoperative information ,
Time frame: from december 2021 to september 2022
Preoperative LMWH aplication Yes No
Preoperative information
Time frame: from december 2021 to september 2022
Preoperative antibiotic prophylaxis Yes No
Preoperative information
Time frame: from december 2021 to september 2022
Bowel preparation Yes No
Preoperative information
Time frame: from december 2021 to september 2022
Skin cleansing with chlorhexidine Yes No
Preoperative information
Time frame: from december 2021 to september 2022
ASA classification I, II, III
Preoperative information
Time frame: from december 2021 to september 2022
Solid food restriction period (hour)....hour
Preoperative information
Time frame: from december 2021 to september 2022
Liquid food restriction period (hour)....hour
Intraoperative applications
Time frame: from december 2021 to september 2022
Type of anesthesia General, spinal
Intraoperative applications
Time frame: from december 2021 to september 2022
NG cathetere application yes No
Intraoperative applications
Time frame: from december 2021 to september 2022
Urinary catheterization application Yes No
Intraoperative applications
Time frame: from december 2021 to september 2022
Drain application Yes No
Intraoperative applications
Time frame: from december 2021 to september 2022
Epidural analgesia administration Yes No
Intraoperative applications
Time frame: from december 2021 to september 2022
Antiemetic agent administration Yes No
Intraoperative applications
Time frame: from december 2021 to september 2022
Intraoperative IV fluid amount (cc)......cc
Intraoperative applications
Time frame: from december 2021 to september 2022
Incision length (cm).......cm
Postoperative applications
Time frame: from december 2021 to september 2022
Nausea Yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Heating with a heater Yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Pain score (VAS)1-10
Postoperative applications
Time frame: from december 2021 to september 2022
Analgesic administration Yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Type of analgesic ........
Postoperative applications
Time frame: from december 2021 to september 2022
Posoperative LMWH application Yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Gum chewing app yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Status of providing discharge training Yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Information on control Yes No
Postoperative applications
Time frame: from december 2021 to september 2022
Principle time breastfeeding (minute).......minute
Postoperative applications
Time frame: from december 2021 to september 2022
Time to postoperative gas release (hour)........hour
Postoperative applications
Time frame: from december 2021 to september 2022
Time to postoperative stool output (hour).......hour
Postoperative applications
Time frame: from december 2021 to september 2022
Time to mobilization (hour)...........hour later
Postoperative applications
Time frame: from december 2021 to september 2022
Time to urinary catheter removal (hour)..........hour kater
Postoperative applications
Time frame: from december 2021 to september 2022
Time to oral initiation (hour)........hour
Postoperative applications
Time frame: from december 2021 to september 2022
Hospitalization time (hour)........hour
1 secondary outcome
socio-demographic characteristics.
Time frame: from december 2021 to september 2022
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 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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.
gonca Karataş Baran, phd principal investigator
Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research 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 Cesrean Delivery and Enhanced Recovery After Surgery, run by Gonca Karatas Baran at 1 site in Turkey (Türkiye).
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 1 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 22 Nov 2024. 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 Turkey (Türkiye). 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?
Preoperative applications (time frame: from december 2021 to september 2022). The study lists 33 primary outcomes in all. 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 22 Nov 2024.