I-fECG and STE: 16-28 weeks gestational age.
- Conditions
- HDP, FGR, (Threatened) preterm birth.
- Registration Number
- NL-OMON25988
- Lead Sponsor
- Board of Management Máxima Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 594
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.
- 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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.