General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes

NCT ID: NCT06160583

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-12
• Study Completion Date: 2024-01-31

Brief Summary

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.

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.

Conditions

Anesthesia; Perinatal Morbidity; Maternal-Fetal Relations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Obstetric patients who enter the hospital intubated.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Civil de Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Diego Francisco Gonzalez Pena

Anestesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diego Francisco Gonzalez Peña, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Civil de Guadalajara

María de los Angeles Campechano Ascencio, MSc

Role: STUDY_DIRECTOR

Hospital Civil de Guadalajara

Jorge Bravo Rubio, PhD

Role: STUDY_CHAIR

Hospital Civil de Guadalajara

Ofelia Margarita Ascencio Aceves, MD

Role: STUDY_CHAIR

Hospital Civil de Guadalajara

Locations

Maria de Los Angeles Campechano Ascencio

Guadalajara, Jalisco, Mexico

Countries

Mexico

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Other Identifiers

257/23

Identifier Type: -

Identifier Source: org_study_id