NCT06524713

Brief Summary

Despite global efforts to reduce the rate of cesarean section births worldwide, increase recommendations for elective induction of labor, and promote trials of vaginal birth after previous cesarean deliveries, cesarean rates are steadily rising, varying from country to country. The management of obstetric patients requires the effective and safe application of anesthesia to anticipate and prevent emergencies, ensuring a positive experience for the mother, baby, and their family. Neuraxial anesthesia is considered the gold standard for cesarean section births. In case of an emergency cesarean, the likelihood of general anesthesia increases, making the safe provision of anesthesia more challenging. The choice of anesthesia technique for cesarean section is determined by considering maternal and fetal conditions, accompanying diseases, the urgency of surgery, and the difficulty of procedures. In this study, the investigators will retrospectively examine the anesthesia records of all cesarean section cases treated in the clinic between 2018 and 2022. the investigators aim to analyze demographic data, the anesthesia methods applied, complications, the relationship between surgery time and anesthetic method, the association between anesthesia method and neonatal Apgar scores, and the type of postoperative analgesia administered in the clinic (including regional anesthesia, opioids, non-steroidal anti-inflammatory drugs if performed). The study will be descriptive in nature, aiming to provide insights into commonly applied methods and management in the researcher's clinic.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

January 20, 2024

Last Update Submit

July 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluating the anesthetic management of cesarean section cases in researcher's clinic.

    Researchers will retrospectively review patients' anesthesia records to examine anesthesia management in emergency and elective cases in the clinic.

    2018-2022

  • Evaluating the anesthetic complications of cesarean section cases in researcher's clinic.

    Researchers will retrospectively review patients' anesthesia records to examine common anesthesia related complications in emergency and elective cases in the clinic.

    2018-2022

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women Undergoing Cesarean Section
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Pregnant Women Undergoing Cesarean Section at Kocaeli University Hospital between January 1, 2018, and December 31, 2022

You may qualify if:

  • All Pregnant Women Undergoing Cesarean Section at Kocaeli University Hospital between January 1, 2018, and December 31, 2022

You may not qualify if:

  • Ectopic Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (3)

  • Robson MS. Use of indications to identify appropriate caesarean section rates. Lancet Glob Health. 2018 Aug;6(8):e820-e821. doi: 10.1016/S2214-109X(18)30319-X. No abstract available.

    PMID: 30012256BACKGROUND
  • Society of Maternal-Fetal (SMFM) Publications Committee. Electronic address: pubs@smfm.org. SMFM Statement on Elective Induction of Labor in Low-Risk Nulliparous Women at Term: the ARRIVE Trial. Am J Obstet Gynecol. 2019 Jul;221(1):B2-B4. doi: 10.1016/j.ajog.2018.08.009. Epub 2018 Aug 9.

    PMID: 30098985BACKGROUND
  • Van de Velde M. Anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2001 Jun;14(3):307-10. doi: 10.1097/00001503-200106000-00004.

    PMID: 17019107BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 20, 2024

First Posted

July 29, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations