Table 1.
Summary of the study visits
Screening visit | Randomisation visit | First telephone interview | First follow-up visit | Second telephone interview | Second follow-up visit | Third follow-up visit | Third telephone interview | |
---|---|---|---|---|---|---|---|---|
Gestation | 11–13 weeks | 11–14 weeks | 16 weeks | 19–24 weeks | 28 weeks | 32–34 weeks | 36 weeks | 30 days after the last dose of IMP |
Patient information and characteristics | √ | |||||||
Informed consent | √ | √ | ||||||
Measurement of weight and height | √ | √ | √ | √ | ||||
Measurement of MAP | √ | √ | √ | √ | ||||
Fetal ultrasound scan | √ | √ | √ | √ | ||||
Measurement of uterine artery PI | √ | √ | √ | √ | ||||
Measurement of PAPP-A and PlGF | √ | √ | √ | |||||
Check concomitant medications | √ | √ | √ | √ | √ | √ | ||
IMP dispensing | √ | √ | ||||||
Ensure compliance | √ | √ | √ | √ | √ | |||
Check side effects/adverse events and review of diary card | √ | √ | √ | √ | √ | √ | ||
Discontinue IMP | √ |
IMP, investigational medicinal product; MAP, mean arterial pressure; PlGF, placental growth factor; PAPP-A, pregnancy-associated plasma protein-A; PI, pulsatility index.