Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000759291
Ethics application status
Not required
Date submitted
21/12/2017
Date registered
7/05/2018
Date last updated
7/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors affecting ultrasonography during second trimester fetal anatomic scan
Scientific title
Factors affecting ultrasonography during second trimester fetal anatomic scan
Secondary ID [1] 293658 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 305945 0
Condition category
Condition code
Reproductive Health and Childbirth 305139 305139 0 0
Antenatal care
Reproductive Health and Childbirth 305747 305747 0 0
Normal pregnancy
Reproductive Health and Childbirth 305748 305748 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All examinations were done by the same physician using Voluson E6 (GE) with the abdominal curved probe RAB6-D.
The examination was done as the standards set by ISUOG. Skin to uterus distance was measured in the midpoint between symphysis- umbilicus distance. Measuring the distance between maternal skin and uterus by ultrasonography.
Single examination of approximately 10-30 minutes duration.
Intervention code [1] 299917 0
Diagnosis / Prognosis
Intervention code [2] 300354 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304306 0
Effect of subcutaneous tissue thickness on second trimester fetal anatomy scanning time with USG
Second trimester fetal anatomy scanning time as timed by ultrasound secretary.
Subcutaneous tissue thickness assessed by USG.
Timepoint [1] 304306 0
Assessed once only at time of second trimester fetal anatomy scan
2 months post-enrolment close.
Primary outcome [2] 305352 0
Effect of uterine myomas on second trimester fetal anatomy scanning time with USG.
Second trimester fetal anatomy scanning time as timed by ultrasound secretary.
Uterine myomas assessed by USG.
Timepoint [2] 305352 0
Assessed once only at time of second trimester fetal anatomy scan
2 months post-enrolment close.
Primary outcome [3] 305353 0
Effect of previous surgeries on second trimester fetal anatomy scanning time with USG.
Second trimester fetal anatomy scanning time as timed by ultrasound secretary.
Previous surgeries assessed by patient history.
Timepoint [3] 305353 0
Assessed once only at time of second trimester fetal anatomy scan
2 months post-enrolment close.
Secondary outcome [1] 341537 0
Previous surgeries assessed by patient history.
Timepoint [1] 341537 0
2 months post-enrolment close
Assessed once only at time of second trimester fetal anatomy scan

Eligibility
Key inclusion criteria
19-23 weeks pregnancy.
Normal fetal anatomy
Minimum age
15 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Fetal anomaly(structural/chromosomal)
Patients with unknown first trimester CRL measurement

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Number of patients are decided by clinical assumption.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
Date of last participant enrolment
Anticipated
31/07/2018
Actual
Date of last data collection
Anticipated
31/07/2018
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 9460 0
Turkey
State/province [1] 9460 0
Kocaeli

Funding & Sponsors
Funding source category [1] 298275 0
Self funded/Unfunded
Name [1] 298275 0
Cihan Cetin
Country [1] 298275 0
Turkey
Primary sponsor type
Individual
Name
Cihan Cetin
Address
Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael
Country
Turkey
Secondary sponsor category [1] 297394 0
None
Name [1] 297394 0
Address [1] 297394 0
Country [1] 297394 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 299278 0
Ethics committee address [1] 299278 0
Ethics committee country [1] 299278 0
Date submitted for ethics approval [1] 299278 0
Approval date [1] 299278 0
Ethics approval number [1] 299278 0

Summary
Brief summary
Ultrasonography (USG) has become an important part of antenatal care. It is used for various reasons during pregnancy such as locating the pregnancy, viability, fetal biometry and fetal anatomic evaluation.
As technology advances, both patients and physicians are expecting to diagnose more medical conditions in utero. However several factors are still need to be overcome in order to visualize properly during the USG examinations. Both maternal and fetal factors affect the quality of imaging. These include maternal obesity, previous abdominal/pelvic surgeries, subcutaneous injections, multiple pregnancies etc.
As there is more negative factors for imaging quality, the quality of imaging decreases; which in turn makes the examination times longer and accuracy of diagnoses lesser. These may also cause some medicolegal problems for the physicians. Furthermore, standardization of reporting imaging quality will be beneficial for USG studies for describing the patient characteristics more clearly. Therefore, there is a need for standardization of imaging quality during reporting.
In this study it is aimed to evaluate the effects of various factors in order to standardize the reporting of imaging quality during second trimester fetal anatomic scan.
Materials and Methods
In this prospective cohort study, patients who were admitted for routine second trimester fetal anatomic evaluation with USG between May 2018 and June 2018 were included. Patients between 19-23 weeks of gestation were included. All dating were confirmed with the first trimester CRL measurements. Patients with fetal anatomic/chromosomal anomalies were excluded from the study. All examinations were done by the same physician using Voluson E6 (GE) with the abdominal curved probe RAB6-D.
The examination was done as the standards set by ISUOG. As there was no intervention, ethical committee approval was not required, however all patients gave informed consent that their data for use for scientific purposes.
Skin to uterus distance was measured in the midpoint between symphysis- umbilicus distance.
Trial website
Trial related presentations / publications
Public notes
There is no need for ethics commitee approval because there is no extra intervention made to the patients. After informed consent is taken from the patients, the data will be analyzed.

Contacts
Principal investigator
Name 79886 0
A/Prof Cihan Cetin
Address 79886 0
Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael
Country 79886 0
Turkey
Phone 79886 0
+905332241033
Fax 79886 0
Email 79886 0
[email protected]
Contact person for public queries
Name 79887 0
A/Prof Cihan Cetin
Address 79887 0
Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael
Country 79887 0
Turkey
Phone 79887 0
+905332241033
Fax 79887 0
Email 79887 0
[email protected]
Contact person for scientific queries
Name 79888 0
A/Prof Cihan Cetin
Address 79888 0
Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael
Country 79888 0
Turkey
Phone 79888 0
+905332241033
Fax 79888 0
Email 79888 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
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