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Table 1 Timing of data collection for the APProve trial

From: Study protocol: evaluation of the probiotic Lactobacillus Fermentum CECT5716 for the prevention of mastitis in breastfeeding women: a randomised controlled trial

Peripartum Period Intervention Timing
Birth (1–72 h) Identification of eligible women ≥37 weeks’ gestation
Patient information given, consent, baseline data collected
Postnatal (Birth to 8 weeks) Data collection of treatment compliance, breast pain, infection symptoms and infant feeding Daily x 56 (APP/calendar diary)
Data collection of well-being, Drs’ visits, and medication intake Weekly x 8 (APP/email)
Postnatal (2,6 & 12 months) Follow up questionnaire (post, email or APP) 2 months postpartum
Follow up questionnaire (post, email or APP) 6 months postpartum
Final follow up questionnaire (post, email or APP) 12 months postpartum