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FMCG protocol Date: Time of measurement: Identification number of measurement: System: 1. Measurement procedure: 1.1. Duration of measurement: min none 1.2. Fetal activity during the measurement: (from maternal observation) 1.3. Peculiarities during the measurement: low 1.4. Shortest distance abdominal surface to valve plane of the fetal heart: medium begin of session mm end of session mm 1.5. Distance abdominal surface to cryostat directly above the fetal heart: 2. 2.1. high mm Medical data Data of the pregnant woman 2.1.1. First name, Surname (only for internal use) 2.1.2. Date of birth: no 2.1.3. Chronic diseases persisting during pregnancy: If yes, which? Which? Number of deliveries: 2.1.4. Number of pregnancies (including this): 2.2. yes Diabetes mellitus Adiposity Nicotine abuse Alcohol abuse Other: (see appendix 1) Data of the present pregnancy and the fetus 2.2.1. Completed week of gestation: 2.2.2. Race Caucasian African Afrocaribian Asian South-East Asian/ Chinese: 2.2.3.. Medication during last week: If yes, which? 2.2.4. Findings during the pregnancy: mother: non normal father: yes ß- Sympathomimetica Calcium antagonists Magnesium Glucocorticoids Other Which? abnormal 1 If abnormal, which? Gestational diabetes Placental dysfunction syndrome Premature contractions Hypertension Gestosis/ Preeclampsia Other (see appendix 2) Which? 2 2.2.5. Ultrasound findings Placenta localisation: left Posterior right Anterior Placenta praevia fundal Amniotic fluid: (Estimation from the greatest sea of amniotic fluid in two planes) Oligohydramnios (<4x4) regular (>4x4 cm) 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: Myocardial thickness: mm Internal dimensions: Left ventricle: mm Left ventricle: mm Right ventricle: mm Right ventricle: mm Interventricular septum: mm 2.2.10. Findings of the fetus: If abnormal, which? normal abnormal 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) 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. Date: Date: Date: Data peri- and postnatal 3 2.3.1. Date of birth: 2.3.2. Completed week of gestation: spontaneous vaginal vaginal operative female 2.3.3. Mode of delivery 2.3.4. Sex: caesarean section male 2.3.5. Weight: 2.3.6. Circumference: g 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 Congenital heart disease If abnormal, which? Which? Premature delivery Intrauterine growth retardation Perinatal asphyxia/ hypoxia/ cyanosis Other: (see appendix 4) Which? no 2.3.11. Neonatal ECG: yes abnormal normal Supraventricular tachycardia Ventricular tachycardia Bradycardia Supraventricular extrasystoles Ventricular extrasystoles Atrioventricular block Other: (see appendix 5) Findings of the neonatal ECG: If abnormal, which? Which? ECG in accordance with fMCG? 2.3.12. Placenta no yes weight: g histology: 3. 2.1. 2.2. 2.3. 2.4. Recommended recording parameter: High pass filter: Low pass filter: Sampling frequency: Notch filter: <= 2 Hz 80-500 Hz 1000 Hz 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 PQRSTcomplexes 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: QRS complex: T wave: PQ segment: ST segment: PR interval: QT interval: onset until the end of atrial excitation onset of the Q peak until the end of the S peak onset of the T wave until the end of the T wave isoelectric line from the end of the P wave until the onset of the QRS wave isoelectric line from the end of the QRS complex until the onset of the T wave duration of time between beginning of the P wave and the beginning of the QRS complex 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 during pregnancy 1. Several diseases persisting during pregnancy 1.1. Cardiac 1.2. Pulmonary 1.3. Hepatic 1.4. Renal 1.5. Central nervous 1.6. Psychiatric 2. Coagulopathy (disturbances of haemostasis) 3. Severe psychological diseases 4. Severe social diseases 5. Rhesus incompatibility 6. Microsomia 7. Skeletal abnormalities 8. Disturbances of thyroid function 9. Collagenosis 10. Exposure to external noxa 10.1. Radiation 10.2. Medication (i.e. chemotherapy) 10.3. Chemicals (heavy metals, carbon monoxide) Appendix 2: Course of the present pregnancy 11. 12. 13. 14. 15. 16. 17. Vaginal bleeding Twins/ Triplets Unknown conceptional age Anaemia Proteinuria (>1000 mg/l) Oedema Hypotension Appendix 3: Fetal risk 18. Suspected fetal cardiac diseases 18.1. Ventricular septal defect 18.2. Atrial septal defect 18.3. Fallot’s tetralogy 18.4. Transposition of great arteries 18.5. Pulmonary stenosis 18.6. Myocardial hypertrophy 18.7. Miscellaneous 19. Miscellaneous suspected fetal abnormalities Appendix 4: Perinatal/ Postnatal diagnosis (without cardiac diseases and ECG findings ) 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. IRDS/ cardiopulmonary diseases Shock Haematological diseases Metabolic disturbances Hereditary metabolic defects Thyroid diseases Diseases of the blood Intracranial haemorrhage Convulsions/ neonatal encephalopathy Trauma/ fractures/ pareses Septicaemia Chromosomal abnormalities Anencephalus, hydrocephalus, microcephalus Neural tube defects Abnormalities of eye/ ear/ neck Respirational abnormalities Gastrointestinal abnormalities Genitourinal abnormalities Skeletal abnormalities Diaphragmatic defects, hernias Miscellaneous Appendix 5: Cardiac diseases and findings of the neonatal ECG 41. 42. 43. 44. 45. 46. 47. Ventricular septal defect Atrial septal defect Fallot’s tetralogy Transposition of major arteries Pulmonary stenosis Myocardial hypertrophy Miscellaneous 6