Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2020

Open Access 01-12-2020 | Ultrasound | Study protocol

First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial

Authors: C. S. Pietersma, A. G. M. G. J. Mulders, L. M. Moolenaar, M. G. M. Hunink, A. H. J. Koning, S. P. Willemsen, A. T. J. I. Go, E. A. P. Steegers, M. Rousian

Published in: BMC Pregnancy and Childbirth | Issue 1/2020

Login to get access

Abstract

Background

In recent years it has become clear that fetal anomalies can already be detected at the end of the first trimester of pregnancy by two-dimensional (2D) ultrasound. This is why increasingly in developed countries the first trimester anomaly scan is being offered as part of standard care. We have developed a Virtual Reality (VR) approach to improve the diagnostic abilities of 2D ultrasound. Three-dimensional (3D) ultrasound datasets are used in VR assessment, enabling real depth perception and unique interaction. The aim of this study is to investigate whether first trimester 3D VR ultrasound is of additional value in terms of diagnostic accuracy for the detection of fetal anomalies. Health-related quality of life, cost-effectiveness and also the perspective of both patient and ultrasonographer on the 3D VR modality will be studied.

Methods

Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion. This is a randomized controlled trial with two intervention arms. The control group receives ‘care as usual’: a second trimester 2D advanced ultrasound examination. The intervention group will undergo an additional first trimester 2D and 3D VR ultrasound examination. Following each examination participants will fill in validated questionnaires evaluating their quality of life and healthcare related expenses. Participants’ and ultrasonographers’ perspectives on the 3D VR ultrasound will be surveyed. The primary outcome will be the detection of fetal anomalies. The additional first trimester 3D VR ultrasound examination will be compared to ‘care as usual’. Neonatal or histopathological examinations are considered the gold standard for the detection of congenital anomalies. To reach statistical significance and 80% power with a detection rate of 65% for second trimester ultrasound examination and 70% for the combined detection of first trimester 3D VR and second trimester ultrasound examination, a sample size of 2800 participants is needed.

Discussion

First trimester 3D VR detection of fetal anomalies may improve patients’ quality of life through reassurance or earlier identification of malformations. Results of this study will provide policymakers and healthcare professionals with the highest level of evidence for cost-effectiveness of first trimester ultrasound using a 3D VR approach.

Trial registration

Dutch Trial Registration number NTR6309, date of registration 26 January 2017.
Appendix
Available only for authorised users
Literature
1.
EURO-PERISTAT Project with SCPE and EUROCAT: European Perinatal Health Report. The health and care of pregnant women and babies in Europe in 2010. In.; 2013. www.​europeristat.​com. Accessed 5 Sept 2018.
2.
Dolk H, Loane M, Garne E. The prevalence of congenital anomalies in Europe. Adv Exp Med Biol. 2010;686:349–64.PubMed
3.
Committee on Practice B-O, the American Institute of Ultrasound in M. Practice Bulletin No. 175: Ultrasound in Pregnancy. Obstet Gynecol. 2016;128(6):e241–56.
4.
Excellence NIfHaC: Antenatal care for uncomplicated pregnancies. NICE guideline (CG62). 2008.
5.
Nederlandse Vereniging voor Obstetrie & Gynaecologie: Indicaties voor Prenatale Diagnostiek. 1999.
6.
Karim JN, Roberts NW, Salomon LJ, Papageorghiou AT. Systematic review of first-trimester ultrasound screening for detection of fetal structural anomalies and factors that affect screening performance. Ultrasound Obstet Gynecol. 2017;50(4):429–41.PubMed
7.
Syngelaki A, Chelemen T, Dagklis T, Allan L, Nicolaides KH. Challenges in the diagnosis of fetal non-chromosomal abnormalities at 11-13 weeks. Prenat Diagn. 2011;31(1):90–102.PubMed
8.
Kenkhuis MJA, Bakker M, Bardi F, Fontanella F, Bakker MK, Fleurke-Rozema JH, Bilardo CM. Effectiveness of 12-13-week scan for early diagnosis of fetal congenital anomalies in the cell-free DNA era. Ultrasound Obstet Gynecol. 2018;51(4):463–9.PubMed
9.
Health Council of the Netherlands. Prenatal Screening. The Hague: Health Council of the Netherlands; 2016.
10.
Bartlett LA, Berg CJ, Shulman HB, Zane SB, Green CA, Whitehead S, Atrash HK. Risk factors for legal induced abortion-related mortality in the United States. Obstet Gynecol. 2004;103(4):729–37.PubMed
11.
Grossman D, Blanchard K, Blumenthal P. Complications after second trimester surgical and medical abortion. Reprod Health Matters. 2008;16(31 Suppl):173–82.PubMed
12.
Korenromp MJ, Page-Christiaens GC, van den Bout J, Mulder EJ, Hunfeld JA, Potters CM, Erwich JJ, van Binsbergen CJ, Brons JT, Beekhuis JR, et al. A prospective study on parental coping 4 months after termination of pregnancy for fetal anomalies. Prenat Diagn. 2007;27(8):709–16.PubMed
13.
Harper LM, Wood SL, Jenkins SM, Owen J, Biggio JR. The performance of first-trimester anatomy scan: a decision analysis. Am J Perinatol. 2016;33(10):957–65.PubMedPubMedCentral
14.
Salomon LJ, Alfirevic Z, Audibert F, Kagan KO, Paladini D, Yeo G, Raine-Fenning N, Committee ICS. ISUOG consensus statement on the impact of non-invasive prenatal testing (NIPT) on prenatal ultrasound practice. Ultrasound Obstet Gynecol. 2014;44(1):122–3.PubMed
15.
16.
Rousian M, Koster MPH, Mulders A, Koning AHJ, Steegers-Theunissen RPM, Steegers EAP. Virtual reality imaging techniques in the study of embryonic and early placental health. Placenta. 2018;64(Suppl 1):S29–35.PubMed
17.
Koning AH, Rousian M, Verwoerd-Dikkeboom CM, Goedknegt L, Steegers EA, van der Spek PJ. V-scope: design and implementation of an immersive and desktop virtual reality volume visualization system. Stud Health Technol Inform. 2009;142:136–8.PubMed
18.
Baken L, van Gruting IM, Steegers EA, van der Spek PJ, Exalto N, Koning AH. Design and validation of a 3D virtual reality desktop system for sonographic length and volume measurements in early pregnancy evaluation. J Clin Ultrasound. 2015;43(3):164–70.PubMed
19.
Exalto N, Steegers EA. Robinson's crown-rump length curve: a major step towards human embryonic health evaluation. BJOG. 2019;126(3):310.PubMed
20.
Baken L, Rousian M, Koning AH, Bonsel GJ, Eggink AJ, Cornette JM, Schoonderwaldt EM, Husen-Ebbinge M, Teunissen KK, van der Spek PJ, et al. First-trimester detection of surface abnormalities: a comparison of 2- and 3-dimensional ultrasound and 3-dimensional virtual reality ultrasound. Reprod Sci. 2014;21(8):993–9.PubMedPubMedCentral
21.
Baken L, van Heesch PN, Wildschut HI, Koning AH, van der Spek PJ, Steegers EA, Exalto N. First-trimester crown-rump length and embryonic volume of aneuploid fetuses measured in virtual reality. Ultrasound Obstet Gynecol. 2013;41(5):521–5.PubMed
22.
Baken L, Rousian M, Kompanje EJ, Koning AH, van der Spek PJ, Steegers EA, Exalto N. Diagnostic techniques and criteria for first-trimester conjoined twin documentation: a review of the literature illustrated by three recent cases. Obstet Gynecol Surv. 2013;68(11):743–52.PubMed
23.
Rousian M, Groenenberg IA, Hop WC, Koning AH, van der Spek PJ, Exalto N, Steegers EA. Human embryonic growth and development of the cerebellum using 3-dimensional ultrasound and virtual reality. Reprod Sci. 2013;20(8):899–908.PubMed
24.
Rousian M, Hop WC, Koning AH, van der Spek PJ, Exalto N, Steegers EA. First trimester brain ventricle fluid and embryonic volumes measured by three-dimensional ultrasound with the use of I-space virtual reality. Hum Reprod. 2013;28(5):1181–9.PubMed
25.
Rousian M, Verwoerd-Dikkeboom CM, Koning AH, Hop WC, van der Spek PJ, Exalto N, Steegers EA. Early pregnancy volume measurements: validation of ultrasound techniques and new perspectives. BJOG. 2009;116(2):278–85.PubMed
26.
Rousian M, Verwoerd-Dikkeboom CM, Koning AH, Hop WC, van der Spek PJ, Steegers EA, Exalto N. First trimester umbilical cord and vitelline duct measurements using virtual reality. Early Hum Dev. 2011;87(2):77–82.PubMed
27.
Verwoerd-Dikkeboom CM, Koning AH, Hop WC, Rousian M, Van Der Spek PJ, Exalto N, Steegers EA. Reliability of three-dimensional sonographic measurements in early pregnancy using virtual reality. Ultrasound Obstet Gynecol. 2008;32(7):910–6.PubMed
28.
Visser JJ, Oei EH, Hunink MG. Using cost-effectiveness analysis to measure value in musculoskeletal imaging. Semin Musculoskelet Radiol. 2017;21(1):37–42.PubMed
29.
Eisenberg JM. Clinical economics. A guide to the economic analysis of clinical practices. JAMA. 1989;262(20):2879–86.PubMed
30.
International Counsil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Integrated addendum to ICH E6 (R2): Guideline for Good Clinical Practice. 2016.
31.
32.
Salomon LJ, Alfirevic Z, Bilardo CM, Chalouhi GE, Ghi T, Kagan KO, Lau TK, Papageorghiou AT, Raine-Fenning NJ, Stirnemann J, et al. ISUOG practice guidelines: performance of first-trimester fetal ultrasound scan. Ultrasound Obstet Gynecol. 2013;41(1):102–13.PubMed
33.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83.PubMed
34.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMed
35.
Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
36.
Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Medical Cost Questionnaire (iMCQ). the Netherlands: Institute for Medical Technology Assesment, Erasmus Universiteit Rotterdam; 2013.
37.
Hakkaart-van Roijen L, van der Linden N, Bouwmans CA, Kanters T, Tan SS. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg [Dutch manual for cost research in the healthcare sector]. Diemen, the Netherlands: Zorginstituut Nederland; 2016.
38.
Anderson JL, Waller DK, Canfield MA, Shaw GM, Watkins ML, Werler MM. Maternal obesity, gestational diabetes, and central nervous system birth defects. Epidemiology. 2005;16(1):87–92.PubMed
39.
den Hollander NS, Wessels MW, Niermeijer MF, Los FJ, Wladimiroff JW. Early fetal anomaly scanning in a population at increased risk of abnormalities. Ultrasound Obstet Gynecol. 2002;19(6):570–4.
40.
Chitty LS, Hunt GH, Moore J, Lobb MO. Effectiveness of routine ultrasonography in detecting fetal structural abnormalities in a low risk population. BMJ. 1991;303(6811):1165–9.PubMedPubMedCentral
41.
Stoll C, Tenconi R, Clementi M. Detection of congenital anomalies by fetal Ultrasonographic examination across Europe. Community Genet. 2001;4(4):225–32.PubMed
42.
Eik-Nes SH. The 18-week fetal examination and detection of anomalies. Prenat Diagn. 2010;30(7):624–30.PubMed
43.
Metadata
Title
First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial
Authors
C. S. Pietersma
A. G. M. G. J. Mulders
L. M. Moolenaar
M. G. M. Hunink
A. H. J. Koning
S. P. Willemsen
A. T. J. I. Go
E. A. P. Steegers
M. Rousian
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2020
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-020-03180-8

Other articles of this Issue 1/2020

BMC Pregnancy and Childbirth 1/2020 Go to the issue

Research article

Involvement of CXCL12/CXCR4 in the motility of human first-trimester endometrial epithelial cells through an autocrine mechanism by activating PI3K/AKT signaling

Research article

Antenatal depression: an examination of prevalence and its associated factors among pregnant women attending Harare polyclinics

Research article

Association between vitamin D plasma concentrations and VDR gene variants and the risk of premature birth

Research article

Birth preparedness complication readiness and determinants among pregnant women: a community-based survey from Ethiopia

Case report

Prenatal diagnosis of fetal microhydranencephaly: a case report and literature review

Research article

Pre- and during- labour predictors of dystocia in active phase of labour: a case-control study