Prospective Early Pregnancy Cardiac Imaging&Anatomy Screening PRECISE
Research type
Research Study
Full title
A Prospective Early Pregnancy Cardiac Imaging and Anatomy Screening Study (PRECISE)
IRAS ID
207824
Contact name
Tom Bourne
Contact email
Sponsor organisation
Imperial College Joint Research Compliance Office
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Congenital heart disease (CHD) is the most frequently encountered fetal anomaly, affecting 4 to 8 infants per 1000 births. Moreover, up to 70% of fetuses with CHD have other associated anomalies. Accurate antenatal diagnosis of fetal anomalies is of paramount importance to enable the opportunity for counselling, optimisation of decision-making for continuation of the pregnancy and postnatal surgical management.
The primary assessment of fetal anatomy including the fetal heart in low risk pregnancies does not occur until the 18 to 20 week ‘anomaly scan’. Furthermore, detection rates of CHD remain variable and low which has been largely attributable to the complex cardiac anatomy and operator expertise. In spite of this, there is an increasing body of evidence to suggest that up to 50% of severe fetal anomalies can potentially be diagnosed by 14 weeks gestation.
There is therefore a clear need to prospectively evaluate imaging fetal anatomy and in particular the fetal heart, from 12 to 17 weeks gestation in a more accurate, less operator reliant and reproducible manner. In the PRECISE study we propose the use of novel ultrasound imaging techniques (5D Heart and Crystal Vue) which may simplify examination of the fetal heart and anatomy by using in-built automatic algorithms and new image-contrast enhancement techniques.
The clinical relevance of such a study is that first and early second trimester identification of fetal anatomic defects, if proven to be feasible using the aforementioned novel imaging techniques, will have a great impact on patient care. Earlier identification of CHD, the most frequently encountered anomaly with the highest disease burden, will enable patients to opt for additional assessment including earlier invasive prenatal testing and make more informed decisions regarding treatment options. Moreover, this research has the potential to pave the way for routine screening for fetal anomalies in the first trimester.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/2159
Date of REC Opinion
3 Jan 2017
REC opinion
Further Information Favourable Opinion