Table 2:
Primary and secondary secondary outcomes
| PRIMARY OUTCOME | |
| Outcome Measure | Definition/Assessment |
| Maternal | |
| Peripartum blood transfusion | Any blood transfusion during delivery hospitalization or within 7 days of hospital discharge |
| SECONDARY OUTCOMES | |
| Outcome Measure | Definition/Assessment |
|---|---|
| Maternal | |
| Maternal Hb at delivery | On admission to labor & delivery |
| Maternal anemia at delivery | Hb <11 mg/dL on admission to labor & delivery |
| Maternal ferritin at delivery | On admission to labor and delivery |
| Maternal hemoglobin postpartum day 1 | On postpartum day 1 |
| Cesarean delivery | Cesarean delivery for any indication in patients without prior cesarean deliveries |
| Edinburgh Perinatal Depression Scale (EPDS) score at randomization (baseline) and at 4 – 6weeks postpartum |
From EPDS routinely collected as part of standard of care at randomization and postpartum visit at 4 – 6 weeks |
| Maternal infection | Any infection diagnosed from initiation of treatment until 4 – 6 weeks postpartum |
| Composite maternal complications | Maternal mortality or any one of several maternal morbidities |
| Adverse reactions | |
| Mild/moderate reactions | Nausea/vomiting, abdominal pain, diarrhea, constipation, chest tightness, itching, urticaria, flushing, headache, dizziness, arthralgia, back or joint aches, mild shortness of breath, tachycardia, hypertension or hypotension, or Fishbane reaction. |
| Major infusion reaction | Anaphylaxis-like reactions Non-reassuring fetal heart rate tracing within 24 hours of infusionrequiring delivery |
| Neonatal | |
| Gestational age at delivery | Based on standard obstetric criteria |
| Preterm birth <37 weeks | Gestational age at delivery <37 0/7 weeks (spontaneous or indicated) |
| NICU Admission | Admission to the neonatal intensive care unit for any indication |
| Birth weight | First weight after delivery |
| Umbilical artery pH, bicarbonate, lactate, and base excess | Based on routine cord gases |
| Neonatal hemoglobin | Based on cord blood or first neonatal complete blood count |
| Neonatal Ferritin | Based on cord blood or first neonatal blood draw |
| APGAR scores at 1 and 5 minutes | Routine APGAR scores at delivery |
| Composite neonatal complications | Neonatal mortality or any one of several neonatal morbidities |