Tdap Vaccination Timing for Preeclampsia
Trial Summary
What is the purpose of this trial?
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 showing that early Tdap vaccinations in pregnancy can reduce the incidence of preeclampsia by more than 50%. A prospective clinical research trial is proposed and urgently needed to validate this finding and thereby make a significant contribution in reducing the incidence of this common and severe complication of pregnancy.
Research Team
Craig D Scoville, MD, PhD
Principal Investigator
Institute of Arthritis Research
Eligibility Criteria
This trial is for pregnant women aged 18-42, confirmed at week 12, who are willing to get the Tdap vaccine at either week 28 or week 36 and follow study procedures. They must sign informed consent and have no history of allergic reactions to Tdap or cancer (except certain skin cancers) in the past five years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Baseline
Participants are randomized to receive Tdap vaccination at either week 28 or week 36 and baseline data is collected
Treatment
Participants receive Tdap vaccination at either week 28 or week 36, with placebo given at the alternate week
Follow-up
Participants are monitored for the development of preeclampsia and fetal health outcomes
Treatment Details
Interventions
- Tdap Vaccine
Tdap Vaccine is already approved in United States, Canada, European Union for the following indications:
- Pertussis prevention in newborns
- Tetanus prevention
- Diphtheria prevention
- Pertussis prevention in newborns
- Tetanus prevention
- Diphtheria prevention
- Pertussis prevention in newborns
- Tetanus prevention
- Diphtheria prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institute of Arthritis Research
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborator
Brigham Young University
Collaborator