ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

Normal pregnancy

Reproductive Health and Childbirth

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]

Diagnosis / Prognosis

Intervention code [2]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Assessed once only at time of second trimester fetal anatomy scan
2 months post-enrolment close.

Primary outcome [2]

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]

Assessed once only at time of second trimester fetal anatomy scan
2 months post-enrolment close.

Primary outcome [3]

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]

Assessed once only at time of second trimester fetal anatomy scan
2 months post-enrolment close.

Secondary outcome [1]

Previous surgeries assessed by patient history.

Timepoint [1]

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?

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]

Turkey

State/province [1]

Kocaeli

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Cihan Cetin

Address [1]

Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocaeli

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

A/Prof Cihan Cetin

Address

Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael

Country

Turkey

Phone

+905332241033

Fax

[email protected]

Contact person for public queries

Name

Cihan Cetin

Address

Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael

Country

Turkey

Phone

+905332241033

Fax

[email protected]

Contact person for scientific queries

Name

Cihan Cetin

Address

Kocaeli Derince Egitim Arastirma Hast Alikahya Yerleskesi Perinatoloji 41000 Izmit-Kocael

Country

Turkey

Phone

+905332241033

Fax

[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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically