Table 1 Primary, secondary and related outcomes in the PiP Study

Primary outcomes

Related outcomes

 1. Infant eczema

Immune and inflammatory markers, epigenetic and metabolomic analyses from cord blood

Epigenetic analyses on cord tissue

Genotype and epigenetic analyses on buccal samples

Immune markers and oligosaccharide profiles from breast milk

Skin microbiota analysis from neck and axilla skin swabs and gut microbiota analysis from infant faeces

 2. Infant eczema severity (SCORAD^a)

 3. Infant atopic sensitisation

Immune and inflammatory markers, epigenetic and metabolomic analyses from cord blood

Epigenetic analyses on cord tissue

Genotype and epigenetic analyses on buccal samples

Immune markers and oligosaccharide profiles from breast milk

Skin microbiota analysis from neck and axilla skin swabs and gut microbiota analysis from infant faeces

Secondary Outcomes

Related Outcomes

 1. Maternal gestational diabetes mellitus

Maternal:

 Gestation at delivery.

 Maternal anthropometric measures ^b at birth, and 6 and 12 months post-partum

 Caesarean section

 Fasting lipids and bile acids from fasting maternal blood taken at time of OGTT

 Gut microbiota and faecal SCFA from maternal faecal samples taken in second trimester

Infant:

 Anthropometric measures at birth, and 6 and 12 months

 Neonatal intensive care (NICU) admission

 2. Maternal BV

Premature rupture of membranes

Preterm birth (<37 weeks)

 3. Maternal vaginal GBS colonisation

Infant GBS

 4. Maternal postpartum depression and anxiety

Medication use for emotional/psychological problems

 1. Maternal:

 2. Infant:

  Anthropometric measures

  Bacteraemia/Septicaemia

  Hospitalisations (excluding birth admissions)

  Gastrointestinal symptoms

  Caesarean section rates

  Anthropometric measures

  Bacteraemia/Septicaemia

  Hospitalisations (excluding birth admissions)

  5 min Apgar scores

  Preterm birth

  Neonatal intensive care unit admissions

  Infant symptoms