The INSIGHT Study
Research type
Research Study
Full title
Investigating hormones triggering the onset of sustained lactation
IRAS ID
278264
Contact name
Fadil Hannan
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Background: Breastfeeding is mediated by hormones, which trigger the onset of lactation (known as secretory activation) within the first 4 days after giving birth. Delayed secretory activation represents a major cause of breastfeeding failure. However, the hormone levels required to initiate secretory activation and successful breastfeeding are unknown.
Study objectives:
1. To define the normal hormone ranges required for secretory activation in healthy breastfeeding mothers.
2. Assess whether lactation hormone levels are altered in mothers with risk factors for delayed secretory activation e.g. diabetes, labour or delivery complications.
3. Determine if hormone levels measured during the first 4 days after birth correlate with milk volume and composition.Plan of Investigation:
1. Recruitment: we plan to recruit pregnant women who are intending to breastfeed. Around 400 healthy pregnant women and 600 mothers with risk factors for delayed secretory activation will be recruited within the Oxfordshire region.
2. Sample collection: we will obtain a baseline blood sample during the 3rd trimester, and then obtain multiple blood samples during the first 4 days after giving birth. Blood samples will be collected before and after each breastfeed. Each participant can provide a minimum of 2 blood samples or as many as 16 blood samples during the first 4 days after birth. We will also collect a milk sample on post-partum day 4 or 5 and measure the volume of milk produced during the feed by weighing the baby.
3. Each participant will also keep a diary of when her milk comes in.
4. Sample analysis: Hormones will be measured at the Department of Clinical Biochemistry, John Radcliffe Hospital, and also by researchers at the University of Oxford.Benefits of this study: We plan to use the hormone data obtained from this study to develop biomarkers, which can be used in the clinical evaluation of mothers with low levels of breast milk production.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0172
Date of REC Opinion
11 Sep 2020
REC opinion
Further Information Favourable Opinion