General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes

Completed

• Conditions: Anesthesia; Perinatal Morbidity; Maternal-Fetal Relations

• Registration Number: NCT06160583
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Study Start: 2023-11-12
• Primary Completion: 2023-11-12
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Study Completion: 2024-01-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5000

Inclusion Criteria

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

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Exclusion Criteria

• Obstetric patients who enter the hospital intubated.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prenatal classification by weight and gestational age	5 years	Document prenatal classification of the fetus by weight and gestational age assigned by ultrasound
Apgar Score	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
Size at birth	5 years	Document birth size classification assigned by neonatology
Condition of the newborn	5 years	List the condition of the newborn after his or her initial evaluation (rooming-in/neonatal therapy)
Anesthetic induction	5 years	Describe the medications used for anesthetic induction
Frequency general anesthesia	5 years	Obtain the frequency of obstetric patients undergoing cesarean section surgery under general anesthesia
Maternal and fetal diagnosis	5 years	Specify the diagnoses for which general anesthesia is carried out
Classification physical status	5 years	Know the physical status of patients undergoing cesarean surgery
General anesthesia complications	5 years	Identify complications of the anesthetic technique
Maternal condition at the end of surgery	5 years	List the maternal discharge condition at the end of surgery (intubated/extubated)

Trial Locations

Locations (1)

Maria de Los Angeles Campechano Ascencio; 🇲🇽 Guadalajara, Jalisco, Mexico