NCT05727449

Brief Summary

During the cesarean deliveries, one of the anesthesia techniques, regional anesthesia or general anesthesia (GA) is prefered. Spinal anesthesia (SA) is preferred among the regional anesthesia methods because the onset of anesthesia is faster and muscle relaxation is more suitable for cesarean section anesthesia. Although both methods have advantages and disadvantages, the anesthesia method to be chosen may vary depending on the condition of the mother and fetus. The goal of this retrospective clinical trial is to compare general and spinal anesthesia in cesarean deliveries. The main questions it aims to answer are:

  • Are the anesthesia techniques effect maternal outcome?
  • Are the anesthesia techniques effect fetal outcome?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
862

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

January 22, 2023

Last Update Submit

February 19, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • Apgar 1st minute score

    The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health

    1st minute after birth

  • Apgar 5th minute score

    The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health

    5th minute after birth

  • Umbilical Cord Blood pH

    pH values from umblical cord blood sampling

    at the time of birth

  • Umbilical Cord Blood PCO2

    mmHg

    at the time of birth

  • Umbilical Cord Blood HCO3

    mEq/L

    at the time of birth

  • Umbilical Cord Blood Lactate

    mmol/L

    at the time of birth

  • Umbilical Cord Blood Base Excess

    mEq/L

    at the time of birth

  • need for neonatal intensive care

    need for neonatal intensive care

    up to 24 hours

  • need for maternal intensive care

    need for maternal intensive care

    up to 24 hours

Study Arms (2)

General Anesthesia for Cesarean Delivery

Procedure: General Anesthesia

Spinal Anesthesia for Cesarean Delivery

Procedure: Spinal Anesthesia

Interventions

General Anesthesia was intruduced for Cesarean Delivery

General Anesthesia for Cesarean Delivery

Spinal Anesthesia was intraduced for Cesarean Delivery

Spinal Anesthesia for Cesarean Delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The pregnant women and their babies in 01.01.2019 - 31.12.2019.

You may qualify if:

  • The pregnant women who delivered with cesarean section

You may not qualify if:

  • The pregnant women who delivered with spontan vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34730, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, GeneralAnesthesia, Spinal

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Design

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

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 14, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

January 1, 2021

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations