General or Spinal Anesthesia for Cesarean Delivery

• Sponsor: Istanbul Medeniyet University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05727449
• Collaborator: (none)
• Enrollment: 862
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 35.9

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Anesthesia for Cesarean Delivery	Procedure: General Anesthesia; Procedure: Spinal Anesthesia

Study Design

• Study Type: Observational
• Actual Enrollment: 862 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Jan 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Apgar 1st minute score [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

2. Apgar 5th minute score [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

3. Umbilical Cord Blood pH [at the time of birth]

   pH values from umblical cord blood sampling

4. Umbilical Cord Blood PCO2 [at the time of birth]

   mmHg

5. Umbilical Cord Blood HCO3 [at the time of birth]

   mEq/L

6. Umbilical Cord Blood Lactate [at the time of birth]

   mmol/L

7. Umbilical Cord Blood Base Excess [at the time of birth]

   mEq/L

8. need for neonatal intensive care [up to 24 hours]

   need for neonatal intensive care

9. need for maternal intensive care [up to 24 hours]

   need for maternal intensive care

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

The pregnant women who delivered with cesarean section

Exclusion Criteria:

• The pregnant women who delivered with spontan vaginal delivery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medeniyet University	İ̇stanbul		Turkey	34730

Sponsors and Collaborators

• Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mesure gul nihan ozden, Medical Doctor, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT05727449
• Other Study ID Numbers: IstanbulMU Cesarean Delivery
• First Posted: Feb 14, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Feb 22, 2023