General or Spinal Anesthesia for Cesarean Delivery

February 19, 2023 updated by: mesure gul nihan ozden, Istanbul Medeniyet University

Comparison of The Effects of General and Spinal Anesthesia for Cesarean Delivery on Maternal and Fetal Outcomes: A Retrospective Analysis of Data in a Third Level Hospital

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

862

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İ̇stanbul, Turkey, 34730
        • Istanbul Medeniyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The pregnant women and their babies in 01.01.2019 - 31.12.2019.

Description

Inclusion Criteria:

The pregnant women who delivered with cesarean section

Exclusion Criteria:

  • The pregnant women who delivered with spontan vaginal delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General Anesthesia for Cesarean Delivery
Procedure: General Anesthesia
General Anesthesia was intruduced for Cesarean Delivery
Spinal Anesthesia for Cesarean Delivery
Procedure: Spinal Anesthesia
Spinal Anesthesia was intraduced for Cesarean Delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical Cord Blood pH
Time Frame: at the time of birth
pH values from umblical cord blood sampling
at the time of birth
Umbilical Cord Blood PCO2
Time Frame: at the time of birth
mmHg
at the time of birth
Umbilical Cord Blood HCO3
Time Frame: at the time of birth
mEq/L
at the time of birth
Umbilical Cord Blood Lactate
Time Frame: at the time of birth
mmol/L
at the time of birth
Umbilical Cord Blood Base Excess
Time Frame: at the time of birth
mEq/L
at the time of birth
need for neonatal intensive care
Time Frame: up to 24 hours
need for neonatal intensive care
up to 24 hours
need for maternal intensive care
Time Frame: up to 24 hours
need for maternal intensive care
up to 24 hours
Apgar 1st minute score
Time Frame: 1st minute after birth
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
Time Frame: 5th minute after birth
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

February 4, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMU Cesarean Delivery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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