You are viewing the site in preview mode

Skip to main content

Advertisement

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

From: The Probiotics in Pregnancy Study (PiP Study): rationale and design of a double-blind randomised controlled trial to improve maternal health during pregnancy and prevent infant eczema and allergy

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 (SCORADa)  
 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
Adverse events and safety
 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
  1. a SCORAD SCORing atopic dermatitis
  2. b Maternal height and head circumference recorded at 14–16 weeks gestation only