Pregnancy Clinical Trial
— MAMAOfficial title:
Maternal Antibody in Milk After Vaccination
NCT number | NCT03982732 |
Other study ID # | 18.0068 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 7, 2018 |
Est. completion date | October 31, 2019 |
Single-centre observational pilot study exploring pertussis specific antibody concentration in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational ages. This study is made up of two stages: first stage to confirm recruitment methods and optimise the laboratory assay and a second stage to complete recruitment for the pilot study.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Singleton pregnancy - Received pertussis vaccination between 16 and 32 gestational weeks - Planning to breastfeed Exclusion Criteria: - Received vaccination outside of the 16-32 week window - Not planning to breastfeed - Diagnosis of an immunodeficiency syndrome - Multiple pregnancy |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Georges University Hospital NHS Foundation Trust | Tooting | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London | European Society for Paediatric Infectious Diseases |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti PT IgA at less than 48 hours in colostrum | Anti-pertussis toxin (PT) Immunoglobulin A (IgA) concentration in colostrum | Within 48 hours of delivery | |
Secondary | Total IgA and IgG in colostrum and breastmilk | Total IgA and IgG concentration in colostrum and breastmilk | Within 48 hours and at 14 and 42 days after delivery | |
Secondary | Anti-PT IgA concentration in breastmilk | Anti-PT IgA concentration in breastmilk | At 14 and 42 days following delivery | |
Secondary | Anti-PT IgG concentration in colostrum and breastmilk | Anti-PT IgG concentration in colostrum and breastmilk | Within 48 hours and at 14 and 42 days after delivery | |
Secondary | Anti PT IgG concentration in maternal serum | Anti PT IgG concentration in maternal serum | Within 48 hours of delivery |
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