General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes

October 18, 2024 updated by: Diego Francisco Gonzalez Pena, Hospital Civil de Guadalajara

General Anesthesia in Obstetric Patients for Cesarean Section, Maternal and Perinatal Outcomes

To evaluate the maternal and perinatal outcomes that occur in obstetric patients undergoing cesarean section surgery under general anesthesia at the Fray Antonio Alcalde Civil Hospital of Guadalajara.

Study Overview

Status

Completed

Conditions

Detailed Description

Pregnant patients who required surgical management to resolve the pregnancy via the abdominal route will be identified from the anesthesiology logs and evaluation sheets of the obstetric patient. During the period from January 2019 to December 2023.

The data will be collected in a database made up of Excel software. Maternal data collected:Of the total cesarean surgery procedures, the following are collected: hospital record, the anesthetic technique administered and the date of the surgical intervention.

Patients who underwent surgery under general anesthesia technique will be identified and their demographic data will be recorded (name, age, hospital record, weight, height, BMI, obstetric data, number of pregnancies, births, cesarean sections, abortions, weeks of gestation) diagnosis. , type of intervention, procedure performed The characteristics of the anesthetic technique, the drugs used for anesthetic induction, will also be recorded.

Complications associated with the anesthetic technique will be recorded, such as: intraoperative awakening, failed tracheal intubation and pulmonary aspiration.

The status of the patient's discharge from the operating room, extubated or intubated, will be recorded.

Fetal data collected: Prenatal fetal diagnosis will be obtained, as well as its classification by ultrasound measurement of estimated weight and weeks of gestation assigned to weight appropriate for gestational age, small for gestational age or large for gestational age.

From the results of the newborn, the condition at birth, weight, height, gestational age, as well as the size at birth assigned in: adequate weight, low or high, are recorded.

The Apgar score will be obtained at one minute and at 5 minutes. The condition of the newborn after immediate care will be recorded if he or she remains in rooming-in or is discharged to surveillance, intermediate or intensive therapy.

Data that is not found in the obstetric patient's evaluation sheets will be corroborated in anesthesiology, nursing, neonatology logs and electronic records. Once the database is obtained, the statistical analysis will be carried out.

Study Type

Observational

Enrollment (Actual)

5000

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

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Maria de Los Angeles Campechano Ascencio

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obstetric patients who require cesarean section surgery at the Fray Antonio Alcalde Civil Hospital of Guadalajara

Description

Inclusion Criteria:

  • Obstetric patients who require surgical intervention to resolve the pregnancy, under general anesthesia

Exclusion Criteria:

  • Obstetric patients who enter the hospital intubated.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency general anesthesia
Time Frame: 5 years
Obtain the frequency of obstetric patients undergoing cesarean section surgery under general anesthesia
5 years
Maternal and fetal diagnosis
Time Frame: 5 years
Specify the diagnoses for which general anesthesia is carried out
5 years
Classification physical status
Time Frame: 5 years
Know the physical status of patients undergoing cesarean surgery
5 years
General anesthesia complications
Time Frame: 5 years
Identify complications of the anesthetic technique
5 years
Maternal condition at the end of surgery
Time Frame: 5 years
List the maternal discharge condition at the end of surgery (intubated/extubated)
5 years
Anesthetic induction
Time Frame: 5 years
Describe the medications used for anesthetic induction
5 years
Prenatal classification by weight and gestational age
Time Frame: 5 years
Document prenatal classification of the fetus by weight and gestational age assigned by ultrasound
5 years
Size at birth
Time Frame: 5 years
Document birth size classification assigned by neonatology
5 years
Condition of the newborn
Time Frame: 5 years
List the condition of the newborn after his or her initial evaluation (rooming-in/neonatal therapy)
5 years
Apgar Score
Time Frame: 5 years
Record the newborn's Apgar score Apgar scale It evaluates a score from 0 to 10, the higher the score, the better the baby's progress. a score greater than 7 is considered normal
5 years

Collaborators and Investigators

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

Sponsor

Hospital Civil de Guadalajara

Investigators

  • Principal Investigator: Diego Francisco Gonzalez Peña, MD, Hospital Civil de Guadalajara
  • Study Director: María de los Angeles Campechano Ascencio, MSc, Hospital Civil de Guadalajara
  • Study Chair: Jorge Bravo Rubio, PhD, Hospital Civil de Guadalajara
  • Study Chair: Ofelia Margarita Ascencio Aceves, MD, Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 12, 2023

Primary Completion (Actual)

November 12, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 257/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The records collected will be used exclusively for the results of this protocol

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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