Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Pre-Eclampsia, Diphtheria, Tetanus and Pertussis Vaccine Reaction
In brief
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.
Key facts
- Study ID
- NCT04424693
- Run by
- Institute of Arthritis Research
- People needed
- 1600
- Starts
- 2020-12-01
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2020-06-16
Who can join
Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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) -
Where it is running
- Institute of Arthritis Research — Idaho Falls, Idaho, United States
Full record on ClinicalTrials.gov
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