Non-invasive fetal electrocardiography, electrohysterography and speckle-tracking echocardiography in the second trimester: study protocol of a longitudinal prospective cohort study (BEATS-study)

Abstract Background Worldwide, hypertensive disorders of pregnancy (HDP), fetal growth restriction (FGR) and preterm birth remain the leading causes of maternal and fetal pregnancy-related mortality and (long-term) morbidity. Fetal cardiac deformation changes can be the first sign of placental dysfu...

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Published in:	BMC pregnancy and childbirth Vol. 21; no. 1; pp. 1 - 791
Main Authors:	Nichting, T. J., Frenken, M. W. E., van der Woude, D. A. A., van Oostrum, N. H. M., de Vet, C. M., van Willigen, B. G., van Laar, J. O. E. H., van der Ven, M., Oei, S. G.
Format:	Journal Article
Language:	English
Published:	London BioMed Central 25-11-2021 BMC
Subjects:	Cohort analysis Dehydrogenases Electrocardiography Electrohysterography Enzymes Fetal growth restriction Fetuses Heart rate Hormones Hypertension Hypertensive disorders of pregnancy Ischemia Medical research Midwifery Non-invasive fetal electrocardiography Obstetrics Pathophysiology Physiology Pregnancy Pregnancy complications Premature birth Preterm birth Speckle-tracking echocardiography Study Protocol Ultrasonic imaging Womens health Netherlands
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Summary:	Abstract Background Worldwide, hypertensive disorders of pregnancy (HDP), fetal growth restriction (FGR) and preterm birth remain the leading causes of maternal and fetal pregnancy-related mortality and (long-term) morbidity. Fetal cardiac deformation changes can be the first sign of placental dysfunction, which is associated with HDP, FGR and preterm birth. In addition, preterm birth is likely associated with changes in electrical activity across the uterine muscle. Therefore, fetal cardiac function and uterine activity can be used for the early detection of these complications in pregnancy. Fetal cardiac function and uterine activity can be assessed by two-dimensional speckle-tracking echocardiography (2D-STE), non-invasive fetal electrocardiography (NI-fECG), and electrohysterography (EHG). This study aims to generate reference values for 2D-STE, NI-fECG and EHG parameters during the second trimester of pregnancy and to investigate the diagnostic potential of these parameters in the early detection of HDP, FGR and preterm birth. Methods In this longitudinal prospective cohort study, eligible women will be recruited from a tertiary care hospital and a primary midwifery practice. In total, 594 initially healthy pregnant women with an uncomplicated singleton pregnancy will be included. Recordings of NI-fECG and EHG will be made weekly from 22 until 28 weeks of gestation and 2D-STE measurements will be performed 4-weekly at 16, 20, 24 and 28 weeks gestational age. Retrospectively, pregnancies complicated with pregnancy-related diseases will be excluded from the cohort. Reference values for 2D-STE, NI-fECG and EHG parameters will be assessed in uncomplicated pregnancies. After, 2D-STE, NI-fCG and EHG parameters measured during gestation in complicated pregnancies will be compared with these reference values. Discussion This will be the a large prospective study investigating new technologies that could potentially have a high impact on antepartum fetal monitoring. Trial registration Registered on 26 March 2020 in the Dutch Trial Register (NL8769) via https://www.trialregister.nl/trials and registered on 21 October 2020 to the Central Committee on Research Involving Human Subjects (NL73607.015.20) via https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm .
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	1471-2393 1471-2393
DOI:	10.1186/s12884-021-04265-8