NCT06672198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

October 25, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

Cesarean sectionEnhanced recovery after surgeryPerioperative

Outcome Measures

Primary Outcomes (33)

  • Preoperative applications

    Sedative premedication Yes No

    from december 2021 to september 2022

  • Preoperative information

    Preoperative IV fluid ......cc

    from december 2021 to september 2022

  • Preoperative information ,

    Preoperative LMWH aplication Yes No

    from december 2021 to september 2022

  • Preoperative information

    Preoperative antibiotic prophylaxis Yes No

    from december 2021 to september 2022

  • Preoperative information

    Bowel preparation Yes No

    from december 2021 to september 2022

  • Preoperative information

    Skin cleansing with chlorhexidine Yes No

    from december 2021 to september 2022

  • Preoperative information

    ASA classification I, II, III

    from december 2021 to september 2022

  • Preoperative information

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

    from december 2021 to september 2022

  • Preoperative information

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

    from december 2021 to september 2022

  • Intraoperative applications

    Type of anesthesia General, spinal

    from december 2021 to september 2022

  • Intraoperative applications

    NG cathetere application yes No

    from december 2021 to september 2022

  • Intraoperative applications

    Urinary catheterization application Yes No

    from december 2021 to september 2022

  • Intraoperative applications

    Drain application Yes No

    from december 2021 to september 2022

  • Intraoperative applications

    Epidural analgesia administration Yes No

    from december 2021 to september 2022

  • Intraoperative applications

    Antiemetic agent administration Yes No

    from december 2021 to september 2022

  • Intraoperative applications

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

    from december 2021 to september 2022

  • Intraoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

    Nausea Yes No

    from december 2021 to september 2022

  • Postoperative applications

    Heating with a heater Yes No

    from december 2021 to september 2022

  • Postoperative applications

    Pain score (VAS)1-10

    from december 2021 to september 2022

  • Postoperative applications

    Analgesic administration Yes No

    from december 2021 to september 2022

  • Postoperative applications

    Type of analgesic ........

    from december 2021 to september 2022

  • Postoperative applications

    Posoperative LMWH application Yes No

    from december 2021 to september 2022

  • Postoperative applications

    Gum chewing app yes No

    from december 2021 to september 2022

  • Postoperative applications

    Status of providing discharge training Yes No

    from december 2021 to september 2022

  • Postoperative applications

    Information on control Yes No

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

  • Postoperative applications

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

    from december 2021 to september 2022

Secondary Outcomes (1)

  • socio-demographic characteristics.

    from december 2021 to september 2022

Study Arms (1)

cesarean delivery

women undergoing elective caesarean section

Procedure: ERAC protocol

Interventions

ERAC protocolPROCEDURE

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.

cesarean delivery

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who were hospitalized in the CS.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women who had elective CS surgery in the XX hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, yenimahalle, 06010, Turkey (Türkiye)

Location

Study Officials

  • gonca Karataş Baran, phd

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Nurse

Study Record Dates

First Submitted

October 25, 2024

First Posted

November 4, 2024

Study Start

December 1, 2021

Primary Completion

December 1, 2021

Study Completion

September 1, 2022

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations