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 | |||||
