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NCT Number: NCT06160583

General Anesthesia 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.

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Key information

Conditions

Anesthesia Maternal-Fetal Relations Perinatal Morbidity

Age range

14 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Maria de Los Angeles Campechano Ascencio

Guadalajara, Jalisco, 44100, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Obstetric patients who enter the hospital intubated.

Treatment and study plan

Primary outcomes

  1. Frequency general anesthesia

    Time frame: 5 years

    Obtain the frequency of obstetric patients undergoing cesarean section surgery under general anesthesia

  2. Maternal and fetal diagnosis

    Time frame: 5 years

    Specify the diagnoses for which general anesthesia is carried out

  3. Classification physical status

    Time frame: 5 years

    Know the physical status of patients undergoing cesarean surgery

  4. General anesthesia complications

    Time frame: 5 years

    Identify complications of the anesthetic technique

  5. Maternal condition at the end of surgery

    Time frame: 5 years

    List the maternal discharge condition at the end of surgery (intubated/extubated)

  6. Anesthetic induction

    Time frame: 5 years

    Describe the medications used for anesthetic induction

  7. 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

  8. 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

  9. Size at birth

    Time frame: 5 years

    Document birth size classification assigned by neonatology

  10. Condition of the newborn

    Time frame: 5 years

    List the condition of the newborn after his or her initial evaluation (rooming-in/neonatal therapy)

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 7, 2023
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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