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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06160583
Other study ID # 257/23
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 12, 2023
Est. completion date January 31, 2024

Study information

Verified date November 2023
Source Hospital Civil de Guadalajara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5000
Est. completion date January 31, 2024
Est. primary completion date November 12, 2023
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Mexico Maria de Los Angeles Campechano Ascencio Guadalajara Jalisco

Sponsors (1)

Lead Sponsor Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (52)

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Hassanin AS, El-Shahawy HF, Hussain SH, Bahaa Eldin AM, Elhawary MM, Elbakery M, Elsafty MSE. Impact of interval between induction of spinal anesthesia to delivery on umbilical arterial cord ph of neonates delivered by elective cesarean section. BMC Pregn — View Citation

Hollowell J, Pillas D, Rowe R, Linsell L, Knight M, Brocklehurst P. The impact of maternal obesity on intrapartum outcomes in otherwise low risk women: secondary analysis of the Birthplace national prospective cohort study. BJOG. 2014 Feb;121(3):343-55. d — View Citation

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* Note: There are 52 references in allClick here to view all references

Outcome

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