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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