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

Recruiting

Conditions: Zwangerschap: complicaties bij de foetus tijdens de zwangerschap
fetal growth restriction
Hypertensive disorders of pregnancy
10026908

Registration Number: NL-OMON52760

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 594

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

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

Secondary Outcome Measures

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