AnesthesiaNCT06524713
A 5-Year Anesthetic Evaluation of Cases Undergoing Cesarean Section Delivery ın Our Clinic
An observational study of Anesthesia and Cesarean Section, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Despite global efforts to reduce the rate of cesarean section births worldwide, increase recommendations for elective induction of labor, and promote trials of vaginal birth after previous cesarean deliveries, cesarean rates are steadily rising, varying from country to country. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anesthesia, Cesarean Section
- How many people
- 2,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: All Pregnant Women Undergoing Cesarean Section at Kocaeli University Hospital between January 1, 2018, and December 31, 2022
Who may be able to join
- All Pregnant Women Undergoing Cesarean Section at Kocaeli University Hospital between January 1, 2018, and December 31, 2022
Who cannot join
- -Ectopic Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 5-Year Retrospective Anesthetic Evaluation of Cases Undergoing Cesarean Section Delivery
Despite global efforts to reduce the rate of cesarean section births worldwide, increase recommendations for elective induction of labor, and promote trials of vaginal birth after previous cesarean deliveries, cesarean rates are steadily rising, varying from country to country.
The management of obstetric patients requires the effective and safe application of anesthesia to anticipate and prevent emergencies, ensuring a positive experience for the mother, baby, and their family.
Read more
Neuraxial anesthesia is considered the gold standard for cesarean section births. In case of an emergency cesarean, the likelihood of general anesthesia increases, making the safe provision of anesthesia more challenging.
The choice of anesthesia technique for cesarean section is determined by considering maternal and fetal conditions, accompanying diseases, the urgency of surgery, and the difficulty of procedures.
In this study, the investigators will retrospectively examine the anesthesia records of all cesarean section cases treated in the clinic between 2018 and 2022. the investigators aim to analyze demographic data, the anesthesia methods applied, complications, the relationship between surgery time and anesthetic method, the association between anesthesia method and neonatal Apgar scores, and the type of postoperative analgesia administered in the clinic (including regional anesthesia, opioids, non-steroidal anti-inflammatory drugs if performed). The study will be descriptive in nature, aiming to provide insights into commonly applied methods and management in the researcher's clinic.
- Conditions
- Anesthesia, Cesarean Section
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the anesthetic management of cesarean section cases in researcher's clinic.
Researchers will retrospectively review patients' anesthesia records to examine anesthesia management in emergency and elective cases in the clinic.
Measured: 2018-2022
Evaluating the anesthetic complications of cesarean section cases in researcher's clinic.
Researchers will retrospectively review patients' anesthesia records to examine common anesthesia related complications in emergency and elective cases in the clinic.
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sare vural yörüsün, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524713
- Sponsor's protocol ID
- SEZRETA1822
- Other IDs
- tsahin
- Status last verified
- Jul 2024
- First submitted
- 20 Jan 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robson MS. Use of indications to identify appropriate caesarean section rates. Lancet Glob Health. 2018 Aug;6(8):e820-e821. doi: 10.1016/S2214-109X(18)30319-X. No abstract available.
PubMed 30012256Society of Maternal-Fetal (SMFM) Publications Committee. Electronic address: pubs@smfm.org. SMFM Statement on Elective Induction of Labor in Low-Risk Nulliparous Women at Term: the ARRIVE Trial. Am J Obstet Gynecol. 2019 Jul;221(1):B2-B4. doi: 10.1016/j.ajog.2018.08.009. Epub 2018 Aug 9.
PubMed 30098985Van de Velde M. Anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2001 Jun;14(3):307-10. doi: 10.1097/00001503-200106000-00004.
PubMed 17019107
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-Year Retrospective Anesthetic Evaluation of Cases Undergoing Cesarean Section Delivery
- ClinicalTrials.gov ID
- NCT06524713
- Acronym / sponsor ID
- SEZRETA1822
- Conditions
- Anesthesia, Cesarean Section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite global efforts to reduce the rate of cesarean section births worldwide, increase recommendations for elective induction of labor, and promote trials of vaginal birth after previous cesarean deliveries, cesarean rates are steadily rising, varying from country to country.
The management of obstetric patients requires the effective and safe application of anesthesia to anticipate and prevent emergencies, ensuring a positive experience for the mother, baby, and their family.
Neuraxial anesthesia is considered the gold standard for cesarean section births. In case of an emergency cesarean, the likelihood of general anesthesia increases, making the safe provision of anesthesia more challenging.
The choice of anesthesia technique for cesarean section is determined by considering maternal and fetal conditions, accompanying diseases, the urgency of surgery, and the difficulty of procedures.
In this study, the investigators will retrospectively examine the anesthesia records of all cesarean section cases treated in the clinic between 2018 and 2022. the investigators aim to analyze demographic data, the anesthesia methods applied, complications, the relationship between surgery time and anesthetic method, the association between anesthesia method and neonatal Apgar scores, and the type of postoperative analgesia administered in the clinic (including regional anesthesia, opioids, non-steroidal anti-inflammatory drugs if performed). The study will be descriptive in nature, aiming to provide insights into commonly applied methods and management in the researcher's clinic.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All Pregnant Women Undergoing Cesarean Section at Kocaeli University Hospital between January 1, 2018, and December 31, 2022
Key inclusion criteria (1 listed)
- All Pregnant Women Undergoing Cesarean Section at Kocaeli University Hospital between January 1, 2018, and December 31, 2022
Key exclusion criteria (1 listed)
- -Ectopic Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluating the anesthetic management of cesarean section cases in researcher's clinic.
Time frame: 2018-2022
Researchers will retrospectively review patients' anesthesia records to examine anesthesia management in emergency and elective cases in the clinic.
Evaluating the anesthetic complications of cesarean section cases in researcher's clinic.
Time frame: 2018-2022
Researchers will retrospectively review patients' anesthesia records to examine common anesthesia related complications in emergency and elective cases in the clinic.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 30012256Robson MS. Use of indications to identify appropriate caesarean section rates. Lancet Glob Health. 2018 Aug;6(8):e820-e821. doi: 10.1016/S2214-109X(18)30319-X. No abstract available.
- Background: PubMed 30098985Society of Maternal-Fetal (SMFM) Publications Committee. Electronic address: pubs@smfm.org. SMFM Statement on Elective Induction of Labor in Low-Risk Nulliparous Women at Term: the ARRIVE Trial. Am J Obstet Gynecol. 2019 Jul;221(1):B2-B4. doi: 10.1016/j.ajog.2018.08.009. Epub 2018 Aug 9.
- Background: PubMed 17019107Van de Velde M. Anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2001 Jun;14(3):307-10. doi: 10.1097/00001503-200106000-00004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Cesarean Section, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the anesthetic management of cesarean section cases in researcher's clinic. (time frame: 2018-2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06524713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.