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

Table 2 Study timeline and investigations

		14-16 Weeks Gestation	26-28 Weeks Gestation	35-37 Weeks Gestation	Birth	3-7 Days After Birth	Infant Age 3 Months	Infant Age 6 Months	Infant Age 12 Months
	Intervention: new bottle study capsules	✓ Intervention commences	✓			✓	✓	Intervention stops
	Questionnaire	✓	✓			✓	✓	✓	✓
Objective measures and samples: Maternal
	Vaginal swab (BV)	✓		✓
	Vagino-rectal swab (GBS)	✓		✓
	Anthropometry^a,b,c,d	✓				✓		✓	✓
	Blood samples (OGTT and serum)		✓^e
	Faecal sample		✓
	3 day food diary		✓
	Cord blood and tissue				✓
	Breast milk					✓
	Skin prick test							✓Completed after birth
Objective measures and samples: Infant
	Anthropometry^a,b,c					✓		✓	✓
	Eczema							✓	✓
	SCORAD							✓	✓
	Faecal sample								✓
	48 hour food diary								✓
	Buccal sample								✓
	Skin swabs								✓
	Skin prick test								✓
Objective measures and samples: Paternal
	Anthropometry^a,b,c					✓Completed at any visit after birth
	Skin prick test					✓Completed at any visit after birth

BV bacterial vaginosis, GBS group B streptococcus, OGTT oral glucose tolerance test, SCORAD scoring atopic dermatitis
^aheight/length ^bweight ^chead circumference ^dwaist circumference ^eexcluding women with pre-existing diabetes

ISSN: 1471-2393