Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36

Pre-Eclampsia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04424693
• Other study ID #: PE-Tdap01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2020
• Source: Institute of Arthritis Research
• Contact: Craig D Scoville, MD,PhD
• Phone: 208-542-9080
• Email: cdscoville[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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) -

Related Conditions & MeSH terms

• Diphtheria
• Diphtheria, Tetanus and Pertussis Vaccine Reaction
• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Tdap Vaccine Administration
Tdap vaccinations are routinely given during pregnancy between weeks 27 and 36 per guidelines of American College Obstetrics and Gynecology (ACOG) -- but this study uniquely is trying to establish that the earlier Tdap vaccinations reduce preeclampsia by more than 50%

Locations

Country	Name	City	State
United States	Institute of Arthritis Research	Idaho Falls	Idaho

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Arthritis Research	Brigham Young University, Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia	Follow the quantitative levels of maternal cytokines in pg/ml: IL-2, IL-4, IL-6, IL-10, TNFa, IL-17, IFNg and placental biomarkers in pg/ml PIGF during pregnancy at weeks 12, 20, and 36 and compare these levels with those women who develop preeclampsia to normal pregnancy cohorts from this study during the same times tested	Through duration of pregnancy at 12, 20 and 36 week of gestation
Other	Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia	Follow the quantitative levels of maternal placental biomarkers in ng/ml sFlt-1 and sEng during pregnancy at weeks 12, 20, and 36 and compare these levels with those women who develop preeclampsia to normal pregnancy cohorts from this study during the same times tested	Through duration of pregnancy at 12, 20 and 36 week of gestation
Primary	Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination	The definition of preeclampsia in this study will follow the guidelines of ACOG inclusive of hypertension, proteinuria, but also other features	Through duration of pregnancy approximately 10 months
Primary	Incidence of preeclampsia in each arm of the study with regards to the quantitative anti-tetanus toxoid antibody level	Test the hypothesis that pregnant women with anti-tetanus toxoid antibody levels <1.0 IU/ml are at higher risk of preeclampsia compared to those with higher levels. Obtain blood levels for anti-tetanus toxoid antibody levels, anti-pertussis antibody levels, and anti-diptheria antibody levels will be tested at weeks 12, 20, and 36	Through duration of pregnancy approximately 10 months
Secondary	Assessment of other potential risk factors for preeclampsia inclusive of BMI, hypertension, prior history of preeclampsia, first pregnancy	Statistical analysis of all possible variables for preeclampsia	Through duration of pregnancy approximately 10 months