Status:
UNKNOWN
Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36
Lead Sponsor:
Institute of Arthritis Research
Collaborating Sponsors:
Louisiana State University Health Sciences Center in New Orleans
Brigham Young University
Conditions:
Pre-Eclampsia
Diphtheria, Tetanus and Pertussis Vaccine Reaction
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
Brief Summary
Preeclampsia is a significant medical condition occurring in 3-8% of pregnancies and impacts deleteriously both maternal and fetal health. An important discovery has been made by Dr Craig D Scoville s...
Detailed Description
A double blinded randomized prospective clinical research study is proposed to validate the hypothesis that Tdap vaccinations at week 28 in pregnancy can reduce the incidence of preeclampsia by more t...
Eligibility Criteria
Inclusion
- 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
- 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) -
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT04424693
Start Date
December 1 2020
End Date
December 31 2024
Last Update
June 16 2020
Active Locations (1)
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1
Institute of Arthritis Research
Idaho Falls, Idaho, United States, 83404