pertussis
Conditions
Interventions
None listed
Sponsors
ZonMW
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: inclusion criteria for pregnant woman: • at least 18 years of age • Being pregnant • Receiving a standard routine Tdap vaccination after at least 20 weeks of gestation in the routine NIP before study entry • Receiving antenatal care in a secondary or tertiary care center because the fetus has signs of FGR or SGA • Signed IC from the parents. • Parents who are willing to adhere to the protocol, perform all planned visits, and sample collections for themselves and their newborn child (in The Netherlands) Inclusion criteria for infants (in utero): • Fulfills the case definition of (50 participants per definition) o SGA and not FGR, or o Early fetal growth restriction, or o Late fetal growth restriction • Alive during inclusion • Considered to be viable for at least the study period.
Exclusion criteria
Exclusion criteria: - All women with one or more missing inclusion criteria - history of having pertussis disease in the year prior to study entry. - Known or suspected serious underlying condition that can interfere with the results of the study such as but not limited to cancer, autoimmune disease, immunodeficiency, seizure disorder or significant psychiatric illness. -Receipt of immune modulating medication, e.g. oral corticosteroids, biologicals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing the antibody concentrations against pertussis, diphtheria, and tetanus, measured in both mother and infant directly after birth and the infant at the age of two months, as well as the transmission ratio from mother to infant, across the following five groups: 1. FGR mother-child pairs, with late-developed FGR after 32 weeks of gestation. 2. FGR mother-child pairs, with early-developed FGR before 32 weeks of gestation. 3. SGA mother-infant pairs 4. Term non-FGR and non-SGA mother-infant pairs 5. Preterm non-FGR and non-SGA mother-infant pairs | — |
Secondary
| Measure | Time frame |
|---|---|
| We compare the antibody concentrations against measles and the respiratory syncytial virus (RSV) immediately after birth among four groups: 1. Mother-child pairs with late FGR, after 32 weeks of pregnancy. 2. Mother-child pairs with early FGR, before 32 weeks of pregnancy. 3. Mother-child pairs with SGA. 4. Mother-child pairs with term-born children without FGR or SGA. Additionally, we investigate the composition of the placentas, focusing on the ratio and expression of FC receptors and B cells, in vaccinated pregnant women: 1. Late FGR pregnancies (n=10). 2. Term pregnancies with a normally growing child (n=10). Furthermore, we describe the medical and sociodemographic characteristics of the study population. We compare the growth, development, and occurrence of infections in FGR and SGA children during the first six months with those of term-born children of mothers who have not received maternal DKT vaccination (historical cohort). | — |
Countries
Netherlands
Contacts
Public ContactN.A.T. Maas
RIVM
Outcome results
None listed