TY - JOUR
T1 - The Welsh study of mothers and babies: protocol for a population-based cohort study to investigate the clinical significance of defined ultrasound findings of uncertain significance
AU - Hurt, Lisa
AU - Wright, Melissa
AU - Brook, Fiona
AU - Thomas, Susan
AU - Dunstan, Frank David John
AU - Fone, David Lawrence
AU - John, Gareth
AU - Morris, Sue
AU - Tucker, David
AU - Wills, Marilyn Ann
AU - Chitty, Lyn
AU - Davies, Colin
AU - Paranjothy, Shantini
N1 - Authors’ contributions: SP, ST, CD, FD, DF and LC designed the study. CD had the original idea for the study, provided professional advice on the obstetric ultrasound and markers, was involved with the development of Radis2 marker screen for the study and provided oversight for the training of sonographers and the quality assurance process. FD and MW provided statistical expertise, DF provided epidemiological expertise and LC provided professional advice on obstetric ultrasound, fetal medicine and genetics and relevance to clinical practice. MW was responsible for the production of a linked study database. MAW provided advice on the women’s perspective in the study design, implementation and interpretation of data. ST and SP were responsible for the co-ordination and management of the study, analysed the data and produced the quality assurance report. SP and LH wrote the first draft of this paper. All authors contributed to the text of the paper, subsequent revisions and the final version of the paper. All authors read and approved the final manuscript.
PY - 2014/5/8
Y1 - 2014/5/8
N2 - Background Improvement in ultrasound imaging has led to the identification of subtle non-structural markers during the 18 ? 20 week fetal anomaly scan, such as echogenic bowel, mild cerebral ventriculomegaly, renal pelvicalyceal dilatation, and nuchal thickening. These markers are estimated to occur in between 0.6% and 4.3% of pregnancies. Their clinical significance, for pregnancy outcomes or childhood morbidity, is largely unknown. The aim of this study is to estimate the prevalence of seven markers in the general obstetric population and establish a cohort of children for longer terms follow-up to assess the clinical significance of these markers. Methods/Design All women receiving antenatal care within six of seven Welsh Health Boards who had an 18 to 20 week ultrasound scan in Welsh NHS Trusts between July 2008 and March 2011 were eligible for inclusion. Data were collected on seven markers (echogenic bowel, cerebral ventriculomegaly, renal pelvicalyceal dilatation, nuchal thickening, cardiac echogenic foci, choroid plexus cysts, and short femur) at the time of 18 ? 20 week fetal anomaly scan. Ultrasound records were linked to routinely collected data on pregnancy outcomes (work completed during 2012 and 2013). Images were stored and reviewed by an expert panel. The prevalence of each marker (reported and validated) will be estimated. A projected sample size of 23,000 will allow the prevalence of each marker to be estimated with the following precision: a marker with 0.50% prevalence to within 0.10%; a marker with 1.00% prevalence to within 0.13%; and a marker with 4.50% prevalence to within 0.27%. The relative risk of major congenital abnormalities, stillbirths, pre-term birth and small for gestational age, given the presence of a validated marker, will be reported. Discussion This is a large, prospective study designed to estimate the prevalence of markers in a population-based cohort of pregnant women and to investigate associations with adverse pregnancy outcomes. The study will also establish a cohort of children that can be followed-up to explore associations between specific markers and longer-term health and social outcomes.
AB - Background Improvement in ultrasound imaging has led to the identification of subtle non-structural markers during the 18 ? 20 week fetal anomaly scan, such as echogenic bowel, mild cerebral ventriculomegaly, renal pelvicalyceal dilatation, and nuchal thickening. These markers are estimated to occur in between 0.6% and 4.3% of pregnancies. Their clinical significance, for pregnancy outcomes or childhood morbidity, is largely unknown. The aim of this study is to estimate the prevalence of seven markers in the general obstetric population and establish a cohort of children for longer terms follow-up to assess the clinical significance of these markers. Methods/Design All women receiving antenatal care within six of seven Welsh Health Boards who had an 18 to 20 week ultrasound scan in Welsh NHS Trusts between July 2008 and March 2011 were eligible for inclusion. Data were collected on seven markers (echogenic bowel, cerebral ventriculomegaly, renal pelvicalyceal dilatation, nuchal thickening, cardiac echogenic foci, choroid plexus cysts, and short femur) at the time of 18 ? 20 week fetal anomaly scan. Ultrasound records were linked to routinely collected data on pregnancy outcomes (work completed during 2012 and 2013). Images were stored and reviewed by an expert panel. The prevalence of each marker (reported and validated) will be estimated. A projected sample size of 23,000 will allow the prevalence of each marker to be estimated with the following precision: a marker with 0.50% prevalence to within 0.10%; a marker with 1.00% prevalence to within 0.13%; and a marker with 4.50% prevalence to within 0.27%. The relative risk of major congenital abnormalities, stillbirths, pre-term birth and small for gestational age, given the presence of a validated marker, will be reported. Discussion This is a large, prospective study designed to estimate the prevalence of markers in a population-based cohort of pregnant women and to investigate associations with adverse pregnancy outcomes. The study will also establish a cohort of children that can be followed-up to explore associations between specific markers and longer-term health and social outcomes.
U2 - 10.1186/1471-2393-14-164
DO - 10.1186/1471-2393-14-164
M3 - Article
SN - 1471-2393
VL - 14
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
M1 - 164 (2014)
ER -