NCT06160583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

Same day

First QC Date

November 29, 2023

Last Update Submit

October 18, 2024

Conditions

Keywords

General anesthesiaMaternoPerinatalOutcomesCesarean

Outcome Measures

Primary Outcomes (10)

  • Frequency general anesthesia

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

    5 years

  • Maternal and fetal diagnosis

    Specify the diagnoses for which general anesthesia is carried out

    5 years

  • Classification physical status

    Know the physical status of patients undergoing cesarean surgery

    5 years

  • General anesthesia complications

    Identify complications of the anesthetic technique

    5 years

  • Maternal condition at the end of surgery

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

    5 years

  • Anesthetic induction

    Describe the medications used for anesthetic induction

    5 years

  • Prenatal classification by weight and gestational age

    Document prenatal classification of the fetus by weight and gestational age assigned by ultrasound

    5 years

  • Apgar Score

    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

  • Size at birth

    Document birth size classification assigned by neonatology

    5 years

  • Condition of the newborn

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

    5 years

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsObstetric patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Obstetric patients who enter the hospital intubated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria de Los Angeles Campechano Ascencio

Guadalajara, Jalisco, 44100, Mexico

Location

Related Publications (52)

  • Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.

  • Ikeda T, Kato A, Bougaki M, Araki Y, Ohata T, Kawashima S, Imai Y, Ninagawa J, Oba K, Chang K, Uchida K, Yamada Y. A retrospective review of 10-year trends in general anesthesia for cesarean delivery at a university hospital: the impact of a newly launched team on obstetric anesthesia practice. BMC Health Serv Res. 2020 May 13;20(1):421. doi: 10.1186/s12913-020-05314-2.

  • Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.

  • Robbins LS, Blanchard CT, Biasini FJ, Powell MF, Casey BM, Tita AT, Harper LM. General anesthesia for cesarean delivery and childhood neurodevelopmental and perinatal outcomes: a secondary analysis of a randomized controlled trial. Int J Obstet Anesth. 2021 Feb;45:34-40. doi: 10.1016/j.ijoa.2020.08.007. Epub 2020 Aug 25.

  • Bowring J, Fraser N, Vause S, Heazell AE. Is regional anaesthesia better than general anaesthesia for caesarean section? J Obstet Gynaecol. 2006 Jul;26(5):433-4. doi: 10.1080/01443610600720345.

  • Lumbiganon P, Moe H, Kamsa-Ard S, Rattanakanokchai S, Laopaiboon M, Kietpeerakool C, Jampathong N, Somjit M, Cecatti JG, Vogel JP, Betran AP, Mittal S, Torloni MR. Outcomes associated with anaesthetic techniques for caesarean section in low- and middle-income countries: a secondary analysis of WHO surveys. Sci Rep. 2020 Jun 23;10(1):10176. doi: 10.1038/s41598-020-66897-8.

  • Metogo JAM, Nana TN, Ngongheh BA, Nyuydzefon EB, Adjahoung CA, Tochie JN, Minkande JZ. General versus regional anaesthesia for caesarean section indicated for acute foetal distress: a retrospective cohort study. BMC Anesthesiol. 2021 Mar 4;21(1):68. doi: 10.1186/s12871-021-01289-7.

  • Swanson K, Liang L, Grobman WA, Higgins N, Roy A, Son M. Duration of Exposure to General Endotracheal Anesthesia during Cesarean Deliveries at Term and Perinatal Complications. Am J Perinatol. 2022 Feb;39(3):232-237. doi: 10.1055/s-0041-1739355. Epub 2021 Nov 29.

  • Ozden MGN, Koruk S, Collak Z, Panik N. Comparison of the effects of general and spinal anesthesia for cesarean delivery on maternal and fetal outcomes: A retrospective analysis of data. North Clin Istanb. 2023 Sep 11;10(5):575-582. doi: 10.14744/nci.2023.25593. eCollection 2023.

  • Devroe S, Van de Velde M, Rex S. General anesthesia for caesarean section. Curr Opin Anaesthesiol. 2015 Jun;28(3):240-6. doi: 10.1097/ACO.0000000000000185.

  • Neef V, Wenk M, Kranke P. [Obstetric Anesthesia]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2023 Oct;58(10):570-582. doi: 10.1055/a-2043-4329. Epub 2023 Oct 13. German.

  • Munro A, Sjaus A. General anesthesia for Cesarean delivery: can interinstitutional variation in practice offer deeper insights into our choice of anesthetic modality? Can J Anaesth. 2024 Feb;71(2):169-174. doi: 10.1007/s12630-023-02634-9. Epub 2023 Nov 6. No abstract available.

  • Mushambi MC, Kinsella SM, Popat M, Swales H, Ramaswamy KK, Winton AL, Quinn AC; Obstetric Anaesthetists' Association; Difficult Airway Society. Obstetric Anaesthetists' Association and Difficult Airway Society guidelines for the management of difficult and failed tracheal intubation in obstetrics. Anaesthesia. 2015 Nov;70(11):1286-306. doi: 10.1111/anae.13260.

  • Munnur U, de Boisblanc B, Suresh MS. Airway problems in pregnancy. Crit Care Med. 2005 Oct;33(10 Suppl):S259-68. doi: 10.1097/01.ccm.0000183502.45419.c9.

  • Jain K, Gupta N, Yadav M, Thulkar S, Bhatnagar S. Radiological evaluation of airway - What an anaesthesiologist needs to know! Indian J Anaesth. 2019 Apr;63(4):257-264. doi: 10.4103/ija.IJA_488_18.

  • Wise RA, Polito AJ, Krishnan V. Respiratory physiologic changes in pregnancy. Immunol Allergy Clin North Am. 2006 Feb;26(1):1-12. doi: 10.1016/j.iac.2005.10.004.

  • Dallmann A, Ince I, Meyer M, Willmann S, Eissing T, Hempel G. Gestation-Specific Changes in the Anatomy and Physiology of Healthy Pregnant Women: An Extended Repository of Model Parameters for Physiologically Based Pharmacokinetic Modeling in Pregnancy. Clin Pharmacokinet. 2017 Nov;56(11):1303-1330. doi: 10.1007/s40262-017-0539-z.

  • Sanghavi M, Rutherford JD. Cardiovascular physiology of pregnancy. Circulation. 2014 Sep 16;130(12):1003-8. doi: 10.1161/CIRCULATIONAHA.114.009029. No abstract available.

  • Sung S, Mikes BA, Martingano DJ, Mahdy H. Cesarean Delivery. 2024 Dec 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546707/

  • Cobb BT, Lane-Fall MB, Month RC, Onuoha OC, Srinivas SK, Neuman MD. Anesthesiologist Specialization and Use of General Anesthesia for Cesarean Delivery. Anesthesiology. 2019 Feb;130(2):237-246. doi: 10.1097/ALN.0000000000002534.

  • Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.

  • Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.

  • Al Rifai RH. Trend of caesarean deliveries in Egypt and its associated factors: evidence from national surveys, 2005-2014. BMC Pregnancy Childbirth. 2017 Dec 13;17(1):417. doi: 10.1186/s12884-017-1591-2.

  • Butwick AJ, Palanisamy A. Mode of anaesthesia for Caesarean delivery and maternal morbidity: can we overcome confounding by indication? Br J Anaesth. 2018 Apr;120(4):621-623. doi: 10.1016/j.bja.2018.01.002. Epub 2018 Feb 14. No abstract available.

  • Elnakib S, Abdel-Tawab N, Orbay D, Hassanein N. Medical and non-medical reasons for cesarean section delivery in Egypt: a hospital-based retrospective study. BMC Pregnancy Childbirth. 2019 Nov 8;19(1):411. doi: 10.1186/s12884-019-2558-2.

  • Schatz M, Dombrowski MP. Clinical practice. Asthma in pregnancy. N Engl J Med. 2009 Apr 30;360(18):1862-9. doi: 10.1056/NEJMcp0809942. No abstract available.

  • Bonhomme V, Staquet C, Montupil J, Defresne A, Kirsch M, Martial C, Vanhaudenhuyse A, Chatelle C, Larroque SK, Raimondo F, Demertzi A, Bodart O, Laureys S, Gosseries O. General Anesthesia: A Probe to Explore Consciousness. Front Syst Neurosci. 2019 Aug 14;13:36. doi: 10.3389/fnsys.2019.00036. eCollection 2019.

  • Siddik-Sayyid S, Zbeidy R. Practice guidelines for obstetric anesthesia--a summary. Middle East J Anaesthesiol. 2008 Oct;19(6):1291-303. No abstract available.

  • Franks NP. General anaesthesia: from molecular targets to neuronal pathways of sleep and arousal. Nat Rev Neurosci. 2008 May;9(5):370-86. doi: 10.1038/nrn2372.

  • McGuire B, Lucas DN. Planning the obstetric airway. Anaesthesia. 2020 Jul;75(7):852-855. doi: 10.1111/anae.14987. Epub 2020 Mar 6. No abstract available.

  • Juang J, Gabriel RA, Dutton RP, Palanisamy A, Urman RD. Choice of Anesthesia for Cesarean Delivery: An Analysis of the National Anesthesia Clinical Outcomes Registry. Anesth Analg. 2017 Jun;124(6):1914-1917. doi: 10.1213/ANE.0000000000001677.

  • Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.

  • Husarova V, McCaul CL. Incidence of general anaesthesia for caesarean section in parturients from different geographic regions: 7-year retrospective study in a single European university centre. Eur J Anaesthesiol. 2016 Jun;33(6):466-8. doi: 10.1097/EJA.0000000000000396. No abstract available.

  • Al-Husban N, Elmuhtaseb MS, Al-Husban H, Nabhan M, Abuhalaweh H, Alkhatib YM, Yousef M, Aloran B, Elyyan Y, Alghazo A. Anesthesia for Cesarean Section: Retrospective Comparative Study. Int J Womens Health. 2021 Feb 2;13:141-152. doi: 10.2147/IJWH.S292434. eCollection 2021.

  • Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, Wijeysundera DN, Scales DC. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019 Feb 5;321(5):493-503. doi: 10.1001/jama.2018.21413.

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  • Sumikura H, Niwa H, Sato M, Nakamoto T, Asai T, Hagihira S. Rethinking general anesthesia for cesarean section. J Anesth. 2016 Apr;30(2):268-73. doi: 10.1007/s00540-015-2099-4. Epub 2015 Nov 19.

  • Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the UK - a national survey. Br J Anaesth. 2016 Sep;117 Suppl 1:i69-i74. doi: 10.1093/bja/aew017. Epub 2016 Feb 24.

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Study Officials

  • Diego Francisco Gonzalez Peña, MD

    Hospital Civil de Guadalajara

    PRINCIPAL INVESTIGATOR
  • MarĂ­a de los Angeles Campechano Ascencio, MSc

    Hospital Civil de Guadalajara

    STUDY DIRECTOR
  • Jorge Bravo Rubio, PhD

    Hospital Civil de Guadalajara

    STUDY CHAIR
  • Ofelia Margarita Ascencio Aceves, MD

    Hospital Civil de Guadalajara

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anestesiologist

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

November 12, 2023

Primary Completion

November 12, 2023

Study Completion

January 31, 2024

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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

Locations