Protocol of Fmcg

FMCG protocol

Date: Time of measurement: Identification number of measurement: System:

1. Measurement procedure:

1.1. Duration of measurement: 1.2. Fetal activity during the measurement:  none  low medium high (from maternal observation) 1.3. Peculiarities during the measurement: 1.4. Shortest distance abdominal surface to valve plane of the fetal heart: begin of session mm end of session mm 1.5. Distance abdominal surface to cryostat directly above the fetal heart: mm

2. Medical data

2.1. Data of the pregnant woman 2.1.1. First name, Surname (only for internal use) 2.1.2. Date of birth: 2.1.3. Chronic diseases persisting during pregnancy:  no  yes If yes, which?  Diabetes mellitus  Adiposity  Nicotine abuse  Alcohol abuse  Other: (see appendix 1) Which? 2.1.4. Number of pregnancies (including this): Number of deliveries:

2.2. Data of the present pregnancy and the fetus 2.2.1. Completed week of gestation: 2.2.2. Race mother: father: Caucasian   African  Afrocaribian  Asian   South-East Asian/ Chinese:     2.2.3.. Medication during last week:  non  yes If yes, which?  ß- Sympathomimetica  Calcium antagonists  Magnesium  Glucocorticoids  Other Which? 2.2.4. Findings during the pregnancy:  normal  abnormal If abnormal, which?  Gestational diabetes  Placental dysfunction syndrome  Premature contractions  Hypertension  Gestosis/ Preeclampsia  Other (see appendix 2)

1 Which?

2 2.2.5. Ultrasound findings Placenta localisation: left right Anterior      Placenta praevia Posterior      fundal Amniotic fluid: (Estimation from the greatest sea of amniotic fluid in two planes)  regular (>4x4 cm)  Oligohydramnios (<4x4)  Hydramnios (>12 cm anterior-posterior) 2.2.6. Doppler velocimetry findings: (if investigated, relevant data at time of the fMCG measurement, Reference see below) regular pathologic values, if pathologic Right uterine artery:    Left uterine artery:     Umbilical artery     Middle cerebral artery (MCA)     2.2.7. Position left right anterior posterior Cephalic position with dorsum       Breech position with dorsum         Transverse position with head     2.2.8. Estimated fetal weight: g 2.2.9. Heart size (see figure 1, +/- one week of measurement) Heart length: mm Heart width: mm Myocardial thickness: Internal dimensions: Left ventricle: mm Left ventricle: mm Right ventricle: mm Right ventricle: mm Interventricular septum: mm 2.2.10. Findings of the fetus:  normal  abnormal If abnormal, which?  Suspected intrauterine growth retardation  Pathological CTG findings  Pathological utero-placental velocimetry  Pathological fetal flow velocimetry  Suspected congenital heart disease Which?  Suspected supraventricular tachycardia  Suspected ventricular tachycardia  Bradycardia  Suspected supraventricular extrasystoles  Suspected ventricular extrasystoles  Other: (see appendix 3) Which?

2.2.11. Cardiotocography: (values) Date: Date: Date: Basal frequency (bpm) Band width:(bpm) Acceleration (number/ 30 min): Deceleration (no; variable; late): Oscillations (< 2; 2-6; > 6/ min): Fisher Score: Assessment: 2.3. Data peri- and postnatal 2.3.1. Date of birth: 2.3.2. Completed week of gestation:

3 2.3.3. Mode of delivery  spontaneous vaginal  vaginal operative  caesarean section 2.3.4. Sex:  female  male 2.3.5. Weight: g 2.3.6. Circumference: head: cm abdomen: cm 2.3.7. Apgar (5 minutes): 2.3.8. Base-Excess: 2.3.9. pH (A.umbilicalis): 2.3.10. Diagnosis of the neonate (excluding ECG):  normal  abnormal If abnormal, which?  Congenital heart disease Which?  Premature delivery  Intrauterine growth retardation  Perinatal asphyxia/ hypoxia/ cyanosis  Other: (see appendix 4) Which? 2.3.11. Neonatal ECG:  no  yes Findings of the neonatal ECG:  normal  abnormal If abnormal, which?  Supraventricular tachycardia  Ventricular tachycardia  Bradycardia  Supraventricular extrasystoles  Ventricular extrasystoles  Atrioventricular block  Other: (see appendix 5) Which? ECG in accordance with fMCG?  no  yes 2.3.12. Placenta weight: g histology:

3. Recommended recording parameter:

2.1. High pass filter: <= 2 Hz 2.2. Low pass filter: 80-500 Hz 2.3. Sampling frequency: 1000 Hz 2.4. Notch filter: off

2.5. Minimum time of measurement for averaged signal: 2 min 2.6. Minimum time of measurement for FHRV: 5 min

After averaging a SNR of at least 10 should be obtained. (Estimation from the best recorded channel.) Noise estimation from a 5-20 ms window with minimum drift, shift for minimum noise.

4 4. Guidelines to data analysis

To obtain the specific data from fetal magnetocardiographic recordings the following processing steps are recommended: Averaging A high quality averaged fetal PQRST-complex is required for the determination of the time intervals. Band pass (1 – 200/500 Hz) filtered raw data is recommended to be used after template or R-peak based averaging. Smoothing filters may be used for template definition and search. To reduce the influence of the maternal MCG, these PQRST- complexes may be required to be averaged first and subtracted from the recorded data before processing of the fetal MCG can be commenced. A control of plausibility (i.e. observation of a beat to beat variability plot or FHR trace) may be used to secure validity of the average.

4.1. Offset / Baseline correction This may be required after averaging and should be performed from a 5 to 20 ms (as long as possible) iso-magnetic interval either before the onset of the P wave or from the PQ segment

4.2. Determination of the time intervals Manual definition of length of P wave, PR interval, QRS complex and QT interval is best performed from unfiltered averaged data. If otherwise filtered data was used, this needs to be specified in the protocol. Onset and offset of the time intervals are defined from the first/last ‘deflection from the zero-line’/event in any of the channels available in each system.

4.3. Protocol of a recording After analysis a complete data set should contain: - number of template matches found - duration of the whole fetal signal and all signal parts according to the definitions given below - qualitative, semi - quantitative or quantitative assessment of fetal activity during the recording (i.e. ultrasound check, online assessment for low frequency artifacts, information from the mother etc.)

5. Definitions of the cardiac time intervals (see figure 2)

P wave: onset until the end of atrial excitation QRS complex: onset of the Q peak until the end of the S peak T wave: onset of the T wave until the end of the T wave PQ segment: isoelectric line from the end of the P wave until the onset of the QRS wave ST segment: isoelectric line from the end of the QRS complex until the onset of the T wave PR interval: duration of time between beginning of the P wave and the beginning of the QRS complex QT interval: duration of time between the beginning of the Q wave to the end of the T wave

All values in milliseconds. Determination of the length of the segments by assessment of as many channels as available: 1. onset determination from the channel with the first event. 2. offset determination from the channel with the final return back to baseline

6. Definitions of the parameters of the fetal heart rate variability

Observed deviations within the train of beat-to-beat intervals (artifacts, ectopic beats) require assessment of their possible patho-physiological impact before sufficient algorithms to remove them can be applied. In general HRV analysis is based on normal-to-normal (NN) heart beat intervals and the method of artifact rejection should be detailed when the results are presented. Heart rate: number of heart beats per minute RR interval: distance between two successive R peaks (in milliseconds) SDRR: standard deviation of all RR intervals (in milliseconds) RMSSD: root mean square of successive differences (in milliseconds)

7. Reference for doppler ultrasound findings:

Kurmanavicius, J., Florio, I., Wisser, J., Hebisch, G., Zimmermann, R., Müller, R., Huch, R., Huch, R. (1997). Reference resistance indices of the umbilical, fetal middle cerebral and uterine arteries at 24-42 weeks of gestation. Ultrasound Obstet. Gynecol., 10, 112-120

5 Appendix 1: Chronic diseases persisting 18.5. Pulmonary stenosis during pregnancy 18.6. Myocardial hypertrophy 18.7. Miscellaneous 1. Several diseases persisting during pregnancy 19. Miscellaneous suspected fetal abnormalities 1.1. Cardiac 1.2. Pulmonary Appendix 4: Perinatal/ Postnatal diagnosis (without 1.3. Hepatic cardiac diseases and ECG findings ) 1.4. Renal 1.5. Central nervous 20. IRDS/ cardiopulmonary diseases 1.6. Psychiatric 21. Shock 2. Coagulopathy (disturbances of haemostasis) 22. Haematological diseases 3. Severe psychological diseases 23. Metabolic disturbances 4. Severe social diseases 24. Hereditary metabolic defects 5. Rhesus incompatibility 25. Thyroid diseases 6. Microsomia 26. Diseases of the blood 7. Skeletal abnormalities 27. Intracranial haemorrhage 8. Disturbances of thyroid function 28. Convulsions/ neonatal encephalopathy 9. Collagenosis 29. Trauma/ fractures/ pareses 10. Exposure to external noxa 30. Septicaemia 10.1. Radiation 31. Chromosomal abnormalities 10.2. Medication (i.e. chemotherapy) 32. Anencephalus, hydrocephalus, microcephalus 10.3. Chemicals (heavy metals, carbon monoxide) 33. Neural tube defects 34. Abnormalities of eye/ ear/ neck Appendix 2: Course of the present pregnancy 35. Respirational abnormalities 36. Gastrointestinal abnormalities 11. Vaginal bleeding 37. Genitourinal abnormalities 12. Twins/ Triplets 38. Skeletal abnormalities 13. Unknown conceptional age 39. Diaphragmatic defects, hernias 14. Anaemia 40. Miscellaneous 15. Proteinuria (>1000 mg/l) 16. Oedema Appendix 5: Cardiac diseases and findings of the 17. Hypotension neonatal ECG

41. Ventricular septal defect Appendix 3: Fetal risk 42. Atrial septal defect 43. Fallot’s tetralogy 18. Suspected fetal cardiac diseases 44. Transposition of major arteries 18.1. Ventricular septal defect 45. Pulmonary stenosis 18.2. Atrial septal defect 46. Myocardial hypertrophy 18.3. Fallot’s tetralogy 47. Miscellaneous 18.4. Transposition of great arteries