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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

27/01/2023

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal respiratory depression

Elective caesarean section

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Surgery

Other surgery

Respiratory

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]

Diagnosis / Prognosis

Intervention code [2]

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]

Oxygenation status assessed using the lung ultrasonography score.

Timepoint [1]

First 10-20 minutes of life after first care of the newborn

Secondary outcome [1]

Clinical condition of the newborn assessed using APGAR scores determined by physical examination.

Timepoint [1]

The first and fifth minutes of the newborn

Secondary outcome [2]

ICU admission within the first 24 hours of life assessed by accessing hospital records.

Timepoint [2]

First 24 hours of newborn

Secondary outcome [3]

Respiratory distress assessed using the Silverman Andersen Respiratory Severity Score

Timepoint [3]

First 24 hours of newborn

Secondary outcome [4]

Neonatal asphyxia assessed as a composite of physical examination and APGAR scores in accordance with the ICD-10.

Timepoint [4]

First 24 hours of newborn

Secondary outcome [5]

Need for resuscitation within the first 24 hours of life assessed by accessing patient electronic medical records

Timepoint [5]

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?

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

Recruiting

Date of first participant enrolment

Anticipated

10/03/2022

Actual

10/03/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1000

Accrual to date

720

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Necmettin Erbakan University Meram Faculty of Medicine

Address [1]

Hocacihan Neighbourhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu/Konya

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NECMETTIN ERBAKAN UNIVERSITY MERAM FACULTY OF MEDICINE CLINICAL RESEARCH ETHICS COMMITTEE

Ethics committee address [1]

Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu/Konya

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

12/01/2022

Ethics approval number [1]

2022/730

Summary

Brief summary

The aim of this study is to investigate whether the type of anesthesia applied in elective cesarean section makes a difference on the general well-being of the newborn, respiratory function, and therefore on the lung ultrasonography images and score.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Gülçin Hacibeyoglu

Address

Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya

Country

Turkey

Phone

+905054455498

Fax

[email protected]

Contact person for public queries

Name

Gülçin Hacibeyoglu

Address

Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya

Country

Turkey

Phone

+905054455498

Fax

[email protected]

Contact person for scientific queries

Name

Gülçin Hacibeyoglu

Address

Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya

Country

Turkey

Phone

+905054455498

Fax

[email protected]

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 ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14818	Study protocol			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically