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 |