FEtal Growth Restriction And Maternal Immunization (FEGRAMI-study)

Pertussis has resurged worldwide. Widespread implementation of maternal pertussis vaccination through a routine tetanus-diphtheria-acellular-pertussis (Tdap) vaccine shows good protection of infants up to 3 months of age (VE 90%). Data on antibody transfer in term and pre-term infants is accumulating. However, data on protection of special groups, e.g., infants with fetal growth restriction (FGR) or infants who are small-for-gestational-age (SGA) are absent. Especially FGR infants are vulnerable for morbidity and mortality due to infectious diseases and late-onset FGR makes up for 70% of the intra-uterine growth restricted cases.

Our primary objective is to evaluate non-inferiority of anti-Pertussis Toxin (PT) IgG in late FGR infants (born ≥ 32 w) at 2m of age born to mothers, who received a standard Tdap vaccina-tion via the routine National Immunization program (NIP) of the Netherlands (currently ≈70% vac-cination coverage) compared to a reference anti-PT at 2m of age in a historical control group of term non-SGA/non-FGR infants born of mothers who were Tdap vaccinated between 30-32w ges-tational age (GA).

We will set up a prospective non-interventional cohort study of women, pregnant of a SGA, FGR or normal fetal growth (NFG) fetus with follow-up of their infants up to 6 months of age. The non-interventional cohort study consists of pregnant women with placental insufficiency of 18 to 64 years who are in secondary or tertiary antenatal care and who are Tdap vaccinated via the routinely NIP of the Netherlands and their fetuses with signs of SGA or FGR. Women received the maternal Tdap vaccination via the NIP before consent to participate in the study.

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