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Fetal myocardial deformation throughout pregnancy


- candidate number28777
- NTR NumberNTR7132
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2018
- Secondary IDsNL64999.015.18 METC Maxima Medical Center
- Public TitleFetal myocardial deformation throughout pregnancy
- Scientific TitleFetal myocardial deformation assessed by speckle tracking; a longitudinal cohort study in the (ab)normal pregnancy
- ACRONYM
- hypothesisfetal heart deformation and its development throughout pregnancy can be measured by speckle tracking.
Fetal heart deformation might be different in pregnancies complicated by placental dysfunction.
- Healt Condition(s) or Problem(s) studiedPregnancy, Fetal heart development, Fetal growth restricion, Fetal growth restriction
- Inclusion criteria-Singleton pregnancy
-Age >18 years
-No suspicion of congenital anomalies that coul
d possibly interfere with fetal cardiac function at anomaly scan -Pregnancies complicated with gestational diabetes (GDM), Fetal growth restriction (FGR) or maternal hypertensive disease, defined as:

GDM:
Hyperglycemia occurring after 20 weeks gestational age. Diagnosis by 75 gram oral glucoses tolerance test; at least one elevated measurement from two measurements taken after fasting > 8 hours followed by 75 gram glucoses taken; first measurement> 7.0 mmol/l and/ or measurement after 2 hours > 7.8 mmol/l

Maternal hypertensive disease, including:
Pregnancy induced hypertension (PIH); systolic blood pressure >140mmHg and/ or diastolic blood pressure >90mmHg occurring after 20 weeks gestational age
Pre-eclampsia (PE): hypertension as defined above and proteinuria (>300mg/24h)
HELLP syndrome: combination of hemolysis (LDH >600 U/L, haptoglobin<0.2g/L, elevated liver enzymes (ASAT or ALAT >70 U/L) and low platelets (<100.109/L), with or without hypertension or PE

Fetal Growth Restriction: estimated fetal weight
-Gestational age >19 weeks
- Exclusion criteria-Multiple pregnancies
-Age <18 years
-Suspicion of congenital anomalies that could possibly interfere with fetal cardiac function.
-Fetal cardiac arrhythmia
-Pre-existent maternal disease that might influence on fetal development; including diabetes mellitus, pre-existent hypertensive disease, auto-immune disease
-Insufficient understanding of Dutch language
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mei-2018
- planned closingdate30-apr-2019
- Target number of participants150
- Interventionsnot applicable; observational study

A DICOM of the fetal heart wil be performed, offline analysis and measuement of fetal heart deformation values per gestational age will be performed. these measurements do not have any cliical implications yet; we study the normal development.
- Primary outcomeIn this longitudinal cohort study, the main study parameter is the determination of normal values of fetal myocardial deformation with increasing gestation.

Normal values of fetal myocardial deformation that can be obtained:
Strain (%)
Strain rate (1/strain)
Velocity (cm/s)
Dyssynchrony (ms)
Sphericity index
Shortening fraction (%)
- Secondary outcomeFetal myocardial deformation values in complicated pregnancies (i.e pregnancies complicated with gestational diabetes, fetal growth restriction, maternal hypertensive disease in pregnancy), will be compared to the values in uncomplicated pregnancies in an explorative pilot study.

Inter-and intra-observer variability will be examined and limits of agreement will be assessed. Analysis of the images will be performed offline by 2 different researchers who are blinded for each other’s results. All the images will be examined twice by the same examiner, leaving 4 weeks in between the examinations so the examiner will be blinded for the first results.
- TimepointsPregnant women, pregnant from a singleton, will be asked for a 4-weekly fetal heart ultrasound examination from 19 gestational age untill birth. Women, pregnant from a growth restricted fetus, will be examined on a weekly base from the moment of diagnosis until birth.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. N.H.M. van Oostrum
- CONTACT for SCIENTIFIC QUERIESDrs. N.H.M. van Oostrum
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryPregnant women, pregnant from a singleton, will be asked for a 4-weekly fetal heart ultrasound examination from 19 gestational age untill birth. Women, pregnant from a growth restricted fetus, will be examined on a weekly base from the moment of diagnosis until birth.
A DICOM of the 4 chamber view of the fetal heart wil be performed at every examination. Offline analysis and measurement of fetal heart deformation values per gestational age will be performed. These measurements do not have any cliical implications yet; we study the normal development. In a pilot study we will compade the deformation values from uncomplciated pregnancies with pregnanciees complicated by fetal growth restriction, hypertensive disease or gestational diabetes.
- Main changes (audit trail)
- RECORD6-apr-2018 - 21-apr-2018


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