Clinical trial NCT04424693: Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36
Official title: A Prospective Randomized Clinical Research Trial Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 and Those Receiving Tdap Vaccinations at Week 36
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pre-Eclampsia
Diphtheria, Tetanus and Pertussis Vaccine Reaction
Keywords: Preeclampsia
Tdap vaccinations
Lead sponsor: Institute of Arthritis Research
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
name: Brigham Young University
First posted: 2020-06-11
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women enlisted in the double blinded study will be randomized to receive Tdap vaccination either at week 28 or week 36 and observed and treated with standard of care.
Primary purpose: TREATMENT

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 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.

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 than 50%. This project will recruit 1600 pregnant women with appropriate informed consent in the first trimester of pregnancy, obtain detailed obstetric and health history, and then randomize these subjects so 800 women receive Tdap at week 28, and 800 women receive Tdap at week 36, and all women will be followed during their pregnancies using standard of care with special attention to preeclampsia and fetal outcomes. Blood samples will be obtained at weeks 12, 20, and 36 in order to test the anti-tetanus toxoid antibody levels, anti-diptheria antibody levels, anti-pertussis antibody levels, and also maternal cytokines (IL-2, IL-4, IL-6, IL-10, TNFa, IL-17, and IFNg), and placental biomarkers (sFlt-1, sEng, and PIGF) for preeclampsia on those patients who develop preeclampsia and compare to those who didn't and thereby better understand the biomarkers of preeclampsia and devise a better formula for positive prediction for preeclampsia. To make this change in clinical practice and save lives, this study is asking for funding from NICHD PA-18-480.

Eligibility criteria: Inclusion Criteria:

1. confirmed pregnancy at week 12
2. Age 18 to 42
3. Willing to participate and sign informed consent documentation
4. willing to follow study procedures with regards to randomization of Tdap and attend all routine clinic visits per obstetrician and standard of care
5. accept Tdap vaccination either at week 28 or week 36

Exclusion Criteria:

1. no history of allergic reaction or intolerance to Tdap vaccination
2. No history of cancer in past 5 years prior to this study (except for non melanoma localized skin cancers or cancer in situ) -

Primary outcomes:
measure: Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination
timeFrame: Through duration of pregnancy approximately 10 months
measure: Incidence of preeclampsia in each arm of the study with regards to the quantitative anti-tetanus toxoid antibody level
timeFrame: Through duration of pregnancy approximately 10 months
Secondary outcomes:
measure: Assessment of other potential risk factors for preeclampsia inclusive of BMI, hypertension, prior history of preeclampsia, first pregnancy
timeFrame: Through duration of pregnancy approximately 10 months
Other outcomes:
measure: Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia
timeFrame: Through duration of pregnancy at 12, 20 and 36 week of gestation
measure: Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia
timeFrame: Through duration of pregnancy at 12, 20 and 36 week of gestation
Locations:
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
Study officials:
affiliation: Institute of Arthritis Research
name: Craig D Scoville, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: