Abstract
BackgroundWorldwide, 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.MethodsIn 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.DiscussionThis will be the a large prospective study investigating new technologies that could potentially have a high impact on antepartum fetal monitoring.Trial registrationRegistered 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.
Highlights
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 morbidity
Hypertensive disorders of pregnancy (HDP), fetal growth restriction (FGR) and preterm birth are three major complications of pregnancy, associated with high maternal and fetal morbidity and mortality. These pregnancy complications have incidences of respectively up to 15 [1], 10 and 18% [2]. They often occur in combination because of an overlapping pathophysiology between HDP, FGR and preterm birth; for this study protocol merged as pregnancy-related diseases (PRD)
PRD manifestation will be related to Two-Dimensional Speckle-Tracking Echocardiography (2D-STE), non-invasive fetal electrocardiography (NI-fECG) and EHG parameters to investigate the diagnostic potential of these parameters and the possibility to develop a prediction model
Summary
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. Hypertensive disorders of pregnancy (HDP), fetal growth restriction (FGR) and preterm birth are three major complications of pregnancy, associated with high maternal and fetal morbidity and mortality. These pregnancy complications have incidences of respectively up to 15 [1], 10 and 18% [2]. The contemporary method for antepartum fetal and uterine monitoring is cardiotocography (CTG), using Doppler ultrasound (DU) and external tocodynamometry (TOCO), in combination with abdominal ultrasound measurements evaluating fetal growth and uteroplacental blood flow None of these tools has been truly successful for the early detection of PRD. There is a need for an antepartum monitoring method that can detect PRD at an early stage of pregnancy, even before clinical symptoms are perceptible, to comprehensively monitor the pregnancy and prevent severe complications
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