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Table 1 Study procedures

From: Does Pentaerytrithyltetranitrate reduce fetal growth restriction in pregnancies complicated by uterine mal-perfusion? Study protocol of the PETN-study: a randomized controlled multicenter-trial

Study Period Recruitment period Treatment period (12–19 weeks) Study visits fourweekly Post-Treatment-Follow-up
Treatment start at inclusion oral intake of 50 mg PETN/Placebo 2 times daily Follow up Follow up child
Event/Visit Inclusion visit at 190 to 226 weeks 240 to 246 weeks 280 to 286 weeks 320 to 326 weeks 360 to 366 weeks 380 to 400 weeks after deliveryh (no visit) Routine check-up at the age of 12 monthi
Informed Consent x        
Inclusion/Exclusion Criteria x        
Randomisation x        
Ultrasound a x x x x x x   
Maternal statusb x x x x x x x (at admission for delivery)  
Haematology/Urinanalysisc x (x) x (x) x x x (if available)  
Maternal conditiond x x x x x x   
Concomitant medicatione x x x x x x   
Checking for AEs incl. SAEs   x x x x x x x
Perinatal outcomef        x  
Maternal morbidityg        x  
Data on child growth and development         x
  1. aassessment of fetal growth: head and abdomen circumference, femur length, doppler of aa. aterinae, a. umbilical and a. cerebri media, amniotic fluid index
  2. bassessment of maternal status: blood pressure, weight
  3. cassessment of haematology and urine: blood count, ASAT, ALAT, LDH, proteinuria and determination of sflt and PlGF amounts and ratio where possible
  4. dassessment of maternal condition: head ache, nausea/vomiting, ear or eye symptoms, pain in the upper abdomen, oedema, others
  5. econcomitant medication: name, dosage, frequency, duration, reason of intake
  6. fassessment of perinatal outcome: weight, height, growth centile, APGAR 1`/5`/10`, pH of umbilical artery, exact gestational age, admission to neonatal intensive care unit, respiratory distress syndrome, occurrence of intraventricular haemorrhage, necrotized enterocolitis, neonatal death
  7. gassessment of maternal morbidity: e. g. Preeclampsia, HELLP syndrome, abruption placentae
  8. hno visit required, post-delivery data will be collected as copies of health reports, discharge or pregnancy reports
  9. iFollow up of the children will be collected as copies of the mandatory standard care visit at the pediatrician at the age of 1 year