Clinical trial NCT06672198: ERAC Protocol in Elective Cesarean Surgery
Official title: "Evaluation of Elective Cesarean Surgery Within the Scope of ERAC Protocol: Where Are We in Türkiye"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesrean Delivery
Enhanced Recovery After Surgery
Keywords: Cesarean section
Enhanced recovery after surgery
Perioperative
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 333
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who had elective CS surgery in the XX hospital

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Preoperative applications
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Preoperative information ,
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Preoperative information
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Intraoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
measure: Postoperative applications
timeFrame: from december 2021 to september 2022
Secondary outcomes:
measure: socio-demographic characteristics.
timeFrame: from december 2021 to september 2022
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital
state: Yenimahalle
Study officials:
affiliation: Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital
name: gonca Karataş Baran, phd
role: PRINCIPAL_INVESTIGATOR
References: