Breastfeeding Pregnancy and Childbirth
Conditions
Interventions
Current intervention as of 10/08/2022:
The INSIGHT study involves the following study procedures:
Baseline (pregnancy):
Blood sample collection on a single occasion during late pregnancy
Postpartum:
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women, aged =18 years 2. Term singleton pregnancy (=37 weeks gestation) 3. Intention to fully or partially breastfeed 4. Willing and able to give informed consent for participation in the study
Exclusion criteria
Exclusion criteria: 1. Severe maternal illness including diagnosis of postpartum depression or psychosis 2. Severe infant illness including major congenital abnormalities and infants who are only expected to live for a short period of time 3. Prolonged separation of infant from mother e.g. due to admission to the neonatal unit 4. Major COVID-19 symptoms e.g. pyrexia and continuous cough 5. Mother or infant infected with blood-borne viruses such as HIV 6. Resides outside of Oxfordshire 7. Safeguarding issues that may impede the safety of research staff carrying out home visits 8. Current participation in another research study that involves investigational medicinal products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/08/2022: INSIGHT study: Serum hormone reference intervals established by parametric or non-parametric analysis during the first 4 days post-partum INSIGHT pilot study: Feasibility of postpartum sample collection: assessed using the proportion of participants willing to be recruited and provide samples on the 4th day postpartum Previous primary outcome measure: Feasibility of postpartum sample collection: assessed using the proportion of participants willing to be recruited and provide samples on the 4th day postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/08/2022: INSIGHT study: The following outcomes will be measured using biochemical analysis during the first 4 days post-partum: 1. Longitudinal changes in serum lactation hormones 2. Associations between serum lactation hormones and maternal co-morbidities, medications, mode of delivery, or pregnancy complications 3. Serum lactation hormone concentrations correlated with timing of onset of milk production 4. Breast milk hormone composition 5. Serum lactation hormones correlated with breast milk volume. INSIGHT pilot study: 1. Lactation hormones measured by immunoassay in blood and urine samples on the 4th day postpartum 2. Breast milk hormones and bioactive molecules measured by immunoassay in breast milk samples on the 4th day postpartum Previous secondary outcome measures: 1. Lactation hormones measured by immunoassay in blood and urine samples on the 4th day postpartum 2. Breast milk hormones and bioactive molecules measured by immunoassay in breast milk samples on the 4th day postpartum | — |
Countries
England, United Kingdom
Outcome results
None listed