Criteria for discontinuing or modifying allocated interventions {11b}
COMPLICATION
Patients can leave the study at any time for any reason if they wish to do so without any consequences. Following a live birth, participants will remain eligible to continue in the study unless the mother and/or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery. Even when a participant randomized to the intervention does not receive the intervention, we will attempt to complete the follow-up data collection to ensure a complete dataset.