Table 1

A fetal indication for delivery in the tadalafil for fetus with early-onset growth restriction (TADAFER) II study23 25 26

Infant survival rate in the neonatal intensive care unit (NICU) (see figure 1)
Zone 1Decide timing of delivery depending on available therapeutic measures at the NICU in each institute.
Zone 2Consider delivery if at least one of three findings is made, but place a high priority on the determination by the investigators.
  1. Reversed umbilical artery blood flow during diastole.

  2. Score less than 4 on the fetal biophysical profile score.

  3. Fetal heart rate patterns in the orange or red category for more than 30 min.26

Zone 3Consider delivery if at least one of the following five findings is made, but place a high priority on the determination by the investigators.
  1. Reversed or absent umbilical artery blood flow during diastole.

  2. Score less than 4 on the fetal biophysical profile score (score less than 6 on the fetal biophysical profile score if oligohydramnios is present).

  3. Fetal heart rate patterns in the orange or red category for more than 30 min.26

  4. Positive contraction stress test.

  5. Impaired fetal head circumference growth for more than 2 weeks.

  • **Regarding exclusion criterion 9 (the investigator decides that entry is inappropriate), this study excludes mothers with mental or psychiatric problems, since poor judgement capabilities that are often associated with such conditions may not be compatible with inclusion criterion 6.