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Trial registered on ANZCTR


Registration number
ACTRN12622000338763
Ethics application status
Approved
Date submitted
26/01/2022
Date registered
24/02/2022
Date last updated
6/11/2024
Date data sharing statement initially provided
24/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the Type of Anesthesia Applied in Non-Emergency Cesarean Section Affect the Ultrasound Image of the Newborn Baby's Lungs?
Scientific title
Does the Type of Anesthesia Applied in Elective Cesarean Section Make a Difference in the Neonatal Lung Ultrasonography Score? Prospective Observational Study
Secondary ID [1] 306277 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal respiratory depression 325172 0
Elective caesarean section 325173 0
Condition category
Condition code
Reproductive Health and Childbirth 322467 322467 0 0
Childbirth and postnatal care
Surgery 322698 322698 0 0
Other surgery
Respiratory 322699 322699 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Lung ultrasonography will be performed within the first 10-20 minutes of life after the first care of the newborn. In the evaluation of the lung by ultrasonography, the lung ultrasonography score, which has been validated by various studies in the adult and pediatric population, will be used. In this scoring system, both lungs are evaluated and the scores given are summed and the lung ultrasound score is obtained. Basically, each lung is divided into 3 areas (upper anterior, lower anterior and lateral) and both transverse and longitudinal scans are performed. For this, a 6-13 megahertz linear probe is used. A score of 0-3 points is given for each lung area (total score is between 0-18). A score of 0 is given for areas with only the presence of A lines, 1 for areas with the presence of 3 or more well-spaced B lines, 2 points for areas with the presence of crowded and combined B lines with or without consolidations limited to the subpleural space, and 3 points for areas with extensive consolidations. . Lines A represent the reflection of the pleura in an air-filled lung, while lines B represent the interstitium and the fluid that fills the alveolar space if they join. Measurements will be made by a trained anesthesiologist. The anesthesiologist who will make the measurement will not know which type of anesthesia is used in the cesarean section and will not be responsible for evaluating the clinical data (Apgar scores, respiratory distress findings) of the babies. For this, lung ultrasonography will be performed in a different room, not in the delivery room where the baby is first cared for.
Gestational age, birth weight, gender, 1st and 5th minute Apgar scores of all babies, what minute of life the lung ultrasonography was performed, the indication for cesarean section (previous cesarean section history, malpresentation, macrosomia suspicion, other), the onset of anesthesia-skin incision time ( initiation of iv injection of propofol for general anesthesia, administration of local anesthetic into the CSF for spinal anesthesia), skin incision-uterine incision time, beginning of anesthesia-uterine incision time, skin incision-cord clamping time, uterine incision-cord clamping time, beginning of anesthesia-cord clamping time, the presence of neonatal asphyxia, whether there is crying at birth, and whether there is a need for resuscitation will be noted. The presence of at least one of the signs of >60 breaths/min, tachycardia 160 beats/min, supraclavicular or intercostal retraction, nasal wing breathing, wheezing in the expiration, hypoxia (<85% saturation in room air) in infants will be considered clinically as respiratory distress and within 30 minutes. If there is no improvement, the baby will be taken to the neonatal intensive care unit. Postnatal stabilization will be performed by a non-study resuscitation team (pediatrician and nurse) and according to current neonatal resuscitation guidelines. APGAR scores, respiratory distress, neonatal asphyxia and hearth rate will be assessed using physical examination and oxygen saturation on pulse oximetry. Lung ultrasonography score will be assessed at 10-20 minutes post-birth and will take approximately 5 minutes to complete. APGAR scores will be assessed at 1 and 5 minutes post-birth. All other observations will occur once only within 24 hours of birth, and will take approximately 30 minutes to complete.
Intervention code [1] 322706 0
Diagnosis / Prognosis
Intervention code [2] 322707 0
Early Detection / Screening
Comparator / control treatment
Outcomes will be compared between babies born with general anaesthesia or those born with spinal anaesthesia. Babies born with spinal anaesthesia will be considered the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 330249 0
Oxygenation status assessed using the lung ultrasonography score.
Timepoint [1] 330249 0
First 10-20 minutes of life after first care of the newborn
Secondary outcome [1] 405463 0
Clinical condition of the newborn assessed using APGAR scores determined by physical examination.
Timepoint [1] 405463 0
The first and fifth minutes of the newborn
Secondary outcome [2] 405464 0
ICU admission within the first 24 hours of life assessed by accessing hospital records.
Timepoint [2] 405464 0
First 24 hours of newborn
Secondary outcome [3] 405465 0
Respiratory distress assessed using the Silverman Andersen Respiratory Severity Score
Timepoint [3] 405465 0
First 24 hours of newborn
Secondary outcome [4] 405466 0
Neonatal asphyxia assessed as a composite of physical examination and APGAR scores in accordance with the ICD-10.
Timepoint [4] 405466 0
First 24 hours of newborn
Secondary outcome [5] 405467 0
Need for resuscitation within the first 24 hours of life assessed by accessing patient electronic medical records
Timepoint [5] 405467 0
First 24 hours of newborn

Eligibility
Key inclusion criteria
ASA I, pregnant women between the ages of 18-40, with a single pregnancy, at least 37 weeks of gestation, who underwent general anesthesia or spinal anesthesia for elective cesarean section, and the relevant applications were decided by an anesthesiologist other than the study team and their newborn babies will be included in the study.
Minimum age
0 Years
Maximum age
24 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Babies born to pregnant women with multiple pregnancies, preterm labor, emergency surgery, placental anomaly, gestational diabetes, eclampsia and preeclampsia, systemic disease, organ failure, bleeding diathesis, and fetal anomaly, intrauterine growth retardation, babies with Low Birth Weight by Week of Gestation (SGA) , meconium and amniotic fluid aspiration will be excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Parametric or non-parametric tests will be used according to the measurement levels of the variables and the results of the normality analysis. While determining whether there is a difference between the groups in terms of variables; Independent Samples T test or Mann-Whitney U test will be used for two-group comparisons, and Wilcoxon Sign test will be used for time-based comparisons within groups. In case of p<0.05, it will be determined that there is a significant difference between the groups, and in the case of p>0.05, there is no significant difference between the groups.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study was planned based on data to be collected in one year. Although the number anticipated before the study was 1000, this number could not be reached. The study and data collection were terminated at the end of one year.
Date of first participant enrolment
Anticipated
10/03/2022
Actual
10/03/2022
Date of last participant enrolment
Anticipated
Actual
10/03/2023
Date of last data collection
Anticipated
Actual
10/03/2023
Sample size
Target
1000
Accrual to date
Final
782
Recruitment outside Australia
Country [1] 24526 0
Turkey
State/province [1] 24526 0

Funding & Sponsors
Funding source category [1] 310626 0
University
Name [1] 310626 0
Necmettin Erbakan University Meram Faculty of Medicine
Country [1] 310626 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University Meram Faculty of Medicine
Address
Hocacihan Neighbourhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu/Konya
Country
Turkey
Secondary sponsor category [1] 311833 0
None
Name [1] 311833 0
None
Address [1] 311833 0
None
Country [1] 311833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310229 0
NECMETTIN ERBAKAN UNIVERSITY MERAM FACULTY OF MEDICINE CLINICAL RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 310229 0
Ethics committee country [1] 310229 0
Turkey
Date submitted for ethics approval [1] 310229 0
Approval date [1] 310229 0
12/01/2022
Ethics approval number [1] 310229 0
2022/730

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116926 0
Dr Gülçin Hacibeyoglu
Address 116926 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 116926 0
Turkey
Phone 116926 0
+905054455498
Fax 116926 0
Email 116926 0
drgulcin81@gmail.com
Contact person for public queries
Name 116927 0
Gülçin Hacibeyoglu
Address 116927 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 116927 0
Turkey
Phone 116927 0
+905054455498
Fax 116927 0
Email 116927 0
drgulcin81@gmail.com
Contact person for scientific queries
Name 116928 0
Gülçin Hacibeyoglu
Address 116928 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 116928 0
Turkey
Phone 116928 0
+905054455498
Fax 116928 0
Email 116928 0
drgulcin81@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Following publication no end date determined
Available to whom?
Only researchers
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator by emailing the Principal Investigator (drgulcin81@gmail.com)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14818Study protocol  drgulcin81@gmail.com



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.