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Table 3 Participant schedule of events

From: Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol

  Enrollment Treatment Delivery Postpartum F/up
Baseline Visit Enroll F/up Refill Contacts Mid-Pregnancy Pre-delivery Hospital Visit Delivery F/up
Timeline 12 to <20 weeks GA Up to14 days after enrollment ~ every 6 weeks after supplement dispensed 28–36 weeks GA PRN as EDD nears During hospital admission 30 days after deliverya
Informed Consent       
Verify Inclusion/Exclusion criteria       
Health History      
Dietary Supplement Intake      
DHA FFQ       
DHQ-II FFQ       
Measure Maternal Height       
Maternal Blood Draw       
Maternal Urine Sample   
33–36 weeks GA
   
Randomization and dispense supplement bottles Start supplements day after enrollment
Continue daily intake until delivery
  
Review of Maternal Medical Records       
Telephone Contact    
Mail Investigational Supplement        
Return Investigational Supplement        b
Delivery Information (if needed, Blood Kits)        
Review of Infant Medical Records        
Cord Blood Collection        
ROI forms       
Participant Compensation       
Adverse Events Record as they occur after enrollment
  1. aDelivery Follow-up Contact will be made 30 days after delivery or after mom and baby have been discharged from the hospital if later than 30 days
  2. bInvestigational Pharmacy will mail participant envelope to return all study capsules after delivery