NI-fECG and STE: 16-28 weeks gestational age.

Non-invasive fetal electrocardiography and speckle tracking echocardiography in the second trimester, 16 until 28 weeks gestational age: a prospective cohort study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25988

Enrollment

594

Registered

2020-03-26

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HDP, FGR, (Threatened) preterm birth.

Interventions

Longitudinal prospective cohort design. Subjects will be recruited at their first antenatal consultation before 16 weeks gestational age. Fetal heart deformation will be analysed 4-weekly at 16, 20, 2

Eligibility

Inclusion criteria

Inclusion criteria: - Pregnant women with a singleton pregnancy; - Uncomplicated pregnancy at the time of inclusion; - Gestational age <16+0 weeks; - Oral and written consent is obtained; - Maternal age = 18 years.

Exclusion criteria

Exclusion criteria: - Multiple pregnancies; - Pre-existing maternal disease that might influence fetal development (e.g. diabetes mellitus, pre-existent hypertensive disease or auto-immune disease); - Abnormalities found at the structural ultrasound examination (SEO) that might possibly influence fetal cardiac function (e.g. fetal cardiac arrhythmias or congenital abnormalities); - Contra-indications to abdominal patch placement (e.g. dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper); - Women connected to an external or implanted electrical stimulator (e.g. a pacemaker); - Insufficient ability in understanding Dutch or English language; - Patient under the age of 18 years.

Design outcomes

Primary

Measure	Time frame
Primary outcomes: to determine reference values in pregnancies without PRD for NFMS parameters (e.g. cardiac time intervals, fetal heart rate variability (fHRV), maternal heart rate variability (mHRV), CTG waveform patterns, contraction amplitude, contraction frequency, velocity, entropy) and 2D-STE parameters (e.g. strain, strainrate, velocity, dyssynchrony, sphericity index, shortening fraction).	—

Measure

Time frame

Primary outcomes: to determine reference values in pregnancies without PRD for NFMS parameters (e.g. cardiac time intervals, fetal heart rate variability (fHRV), maternal heart rate variability (mHRV), CTG waveform patterns, contraction amplitude, contraction frequency, velocity, entropy) and 2D-STE parameters (e.g. strain, strainrate, velocity, dyssynchrony, sphericity index, shortening fraction).

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Secondary

Measure	Time frame
Secondary outcomes: to explore the diagnostic potential of NFMS and 2D-STE parameters during the second trimester (between 16 and 28 weeks gestational age) to compare these parameters between pregnancies with and without PRD, a prediction model for PRD using NFMS and 2D-STE parameters together with demographics. Additional objectives: association between NFMS parameters and 2D-STE parameters, inter- and intra-observer variability of NFMS and 2D-STE, association between fHRV and mHRV, and the association of ultrasound measurements and actual birthweight to diagnose FGR.	—

Measure

Time frame

Secondary outcomes: to explore the diagnostic potential of NFMS and 2D-STE parameters during the second trimester (between 16 and 28 weeks gestational age) to compare these parameters between pregnancies with and without PRD, a prediction model for PRD using NFMS and 2D-STE parameters together with demographics. Additional objectives: association between NFMS parameters and 2D-STE parameters, inter- and intra-observer variability of NFMS and 2D-STE, association between fHRV and mHRV, and the association of ultrasound measurements and actual birthweight to diagnose FGR.

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Contacts

Public ContactThomas Nichting

Máxima Medical Center, Veldhoven, The Netherlands

Thomas.Nichting@mmc.nl+31 6 48649152

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)