Table 1.
6 0/7- 13 6/7 weeks GA | Bi-weekly after enrollment | 4 weeks after enrollment | 16-20 weeks GA | 26-30 weeks GA | 28-30 weeks GA | 34 weeks GA | 36 weeks GA until delivery | 6 weeks Post-Partum | As needed | |
---|---|---|---|---|---|---|---|---|---|---|
Screening | ||||||||||
Initial eligibility | ● | |||||||||
Ultrasound | ● | |||||||||
Consent | ● | |||||||||
Randomization/Enrollment | ● | |||||||||
Clinical Assessments | ||||||||||
Physical exam | ● | |||||||||
Medical history | ● | |||||||||
Use of other medicines | ● | ● | ||||||||
Maternal Hb monitoring | ● | ● | ● | |||||||
BP Monitoring | ● | ● | ● | ● | ● | |||||
Medication Activities | ||||||||||
Instructions for medication use | ● | ● | ||||||||
Medication compliancea | ● | |||||||||
Resupply | ● | |||||||||
Outcome Assessment | ||||||||||
Preterm Birth | ● | |||||||||
SGA | ● | |||||||||
Preeclampsia/Eclampsia | ● | ● | ● | ● | ● | ● | ● | |||
Other maternal outcomes | ● | ● | ● | |||||||
Other fetal outcomes | ● | ● | ||||||||
Unanticipated medical care | ● | ● | ||||||||
Serious Adverse Events | ● | ● | ● |
aMedication is supplied until 36 weeks GA; therefore duration of medication-related monitoring depends on GA at randomization