Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36
Pre-Eclampsia, Diphtheria, Tetanus and Pertussis Vaccine Reaction
About this trial
This is an interventional treatment trial for Pre-Eclampsia focused on measuring Preeclampsia, Tdap vaccinations
Eligibility Criteria
Inclusion Criteria:
- confirmed pregnancy at week 12
- Age 18 to 42
- Willing to participate and sign informed consent documentation
- willing to follow study procedures with regards to randomization of Tdap and attend all routine clinic visits per obstetrician and standard of care
- accept Tdap vaccination either at week 28 or week 36
Exclusion Criteria:
- no history of allergic reaction or intolerance to Tdap vaccination
- No history of cancer in past 5 years prior to this study (except for non melanoma localized skin cancers or cancer in situ) -
Sites / Locations
- Institute of Arthritis Research
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Tdap vaccinations at gestational week 28
Tdap vaccinations at gestational week 36
Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 28 will receive a placebo injection at week 36. Subject will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health
Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 36 will receive a placebo injection at week 28. Subjects will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health