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Completed

NCT Number: NCT06672198

ERAC Protocol in Elective Cesarean Surgery

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital

Ankara, yenimahalle, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery

Exclusion criteria

  • Women who did not have elective CS and did not accept participation in the study are exclusion criteria

Treatment and study plan

ERAC protocol

Procedure

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.

Primary outcomes

  1. Preoperative applications

    Time frame: from december 2021 to september 2022

    Sedative premedication Yes No

  2. Preoperative information

    Time frame: from december 2021 to september 2022

    Preoperative IV fluid ......cc

  3. Preoperative information ,

    Time frame: from december 2021 to september 2022

    Preoperative LMWH aplication Yes No

  4. Preoperative information

    Time frame: from december 2021 to september 2022

    Preoperative antibiotic prophylaxis Yes No

  5. Preoperative information

    Time frame: from december 2021 to september 2022

    Bowel preparation Yes No

  6. Preoperative information

    Time frame: from december 2021 to september 2022

    Skin cleansing with chlorhexidine Yes No

  7. Preoperative information

    Time frame: from december 2021 to september 2022

    ASA classification I, II, III

  8. Preoperative information

    Time frame: from december 2021 to september 2022

    Solid food restriction period (hour)....hour

  9. Preoperative information

    Time frame: from december 2021 to september 2022

    Liquid food restriction period (hour)....hour

  10. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Type of anesthesia General, spinal

  11. Intraoperative applications

    Time frame: from december 2021 to september 2022

    NG cathetere application yes No

  12. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Urinary catheterization application Yes No

  13. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Drain application Yes No

  14. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Epidural analgesia administration Yes No

  15. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Antiemetic agent administration Yes No

  16. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Intraoperative IV fluid amount (cc)......cc

  17. Intraoperative applications

    Time frame: from december 2021 to september 2022

    Incision length (cm).......cm

  18. Postoperative applications

    Time frame: from december 2021 to september 2022

    Nausea Yes No

  19. Postoperative applications

    Time frame: from december 2021 to september 2022

    Heating with a heater Yes No

  20. Postoperative applications

    Time frame: from december 2021 to september 2022

    Pain score (VAS)1-10

  21. Postoperative applications

    Time frame: from december 2021 to september 2022

    Analgesic administration Yes No

  22. Postoperative applications

    Time frame: from december 2021 to september 2022

    Type of analgesic ........

  23. Postoperative applications

    Time frame: from december 2021 to september 2022

    Posoperative LMWH application Yes No

  24. Postoperative applications

    Time frame: from december 2021 to september 2022

    Gum chewing app yes No

  25. Postoperative applications

    Time frame: from december 2021 to september 2022

    Status of providing discharge training Yes No

  26. Postoperative applications

    Time frame: from december 2021 to september 2022

    Information on control Yes No

  27. Postoperative applications

    Time frame: from december 2021 to september 2022

    Principle time breastfeeding (minute).......minute

  28. Postoperative applications

    Time frame: from december 2021 to september 2022

    Time to postoperative gas release (hour)........hour

  29. Postoperative applications

    Time frame: from december 2021 to september 2022

    Time to postoperative stool output (hour).......hour

  30. Postoperative applications

    Time frame: from december 2021 to september 2022

    Time to mobilization (hour)...........hour later

  31. Postoperative applications

    Time frame: from december 2021 to september 2022

    Time to urinary catheter removal (hour)..........hour kater

  32. Postoperative applications

    Time frame: from december 2021 to september 2022

    Time to oral initiation (hour)........hour

  33. Postoperative applications

    Time frame: from december 2021 to september 2022

    Hospitalization time (hour)........hour

Secondary outcomes

  1. socio-demographic characteristics.

    Time frame: from december 2021 to september 2022

    data on socio-demographic characteristics

Sponsors and collaborators

Lead sponsor

Gonca Karatas Baran

Other

Registry information

Official study title

"Evaluation of Elective Cesarean Surgery Within the Scope of ERAC Protocol: Where Are We in Türkiye"

Acronym: Erac

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 4, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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