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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