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

Primary Purpose

Pre-Eclampsia, Diphtheria, Tetanus and Pertussis Vaccine Reaction

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tdap Vaccine Administration
Sponsored by
Institute of Arthritis Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Eclampsia focused on measuring Preeclampsia, Tdap vaccinations

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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) -

Sites / Locations

  • Institute of Arthritis Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tdap vaccinations at gestational week 28

Tdap vaccinations at gestational week 36

Arm Description

Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 28 will receive a placebo injection at week 36. Subject will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health

Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 36 will receive a placebo injection at week 28. Subjects will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2020
Last Updated
June 11, 2020
Sponsor
Institute of Arthritis Research
Collaborators
Louisiana State University Health Sciences Center in New Orleans, Brigham Young University
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1. Study Identification

Unique Protocol Identification Number
NCT04424693
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Arthritis Research
Collaborators
Louisiana State University Health Sciences Center in New Orleans, Brigham Young University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Diphtheria, Tetanus and Pertussis Vaccine Reaction
Keywords
Preeclampsia, Tdap vaccinations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Each study site will designate an "injection nurse" who will be responsible for preparing both placebo and Tdap administration and will be the only one knowing when a patient gets either Tdap injection at week 28 or placebo injection at week 28, or gets Tdap injection at week 36 or placebo injection at week 36. This person will be the only one at each site who will know the randomization of each subject and is the only one who will administer the injection. Every subject will receive Tdap either at week 28 or week 36 and receive placebo injection on the other injection time.
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tdap vaccinations at gestational week 28
Arm Type
Active Comparator
Arm Description
Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 28 will receive a placebo injection at week 36. Subject will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health
Arm Title
Tdap vaccinations at gestational week 36
Arm Type
Active Comparator
Arm Description
Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 36 will receive a placebo injection at week 28. Subjects will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health
Intervention Type
Drug
Intervention Name(s)
Tdap Vaccine Administration
Intervention Description
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%
Primary Outcome Measure Information:
Title
Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination
Description
The definition of preeclampsia in this study will follow the guidelines of ACOG inclusive of hypertension, proteinuria, but also other features
Time Frame
Through duration of pregnancy approximately 10 months
Title
Incidence of preeclampsia in each arm of the study with regards to the quantitative anti-tetanus toxoid antibody level
Description
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
Time Frame
Through duration of pregnancy approximately 10 months
Secondary Outcome Measure Information:
Title
Assessment of other potential risk factors for preeclampsia inclusive of BMI, hypertension, prior history of preeclampsia, first pregnancy
Description
Statistical analysis of all possible variables for preeclampsia
Time Frame
Through duration of pregnancy approximately 10 months
Other Pre-specified Outcome Measures:
Title
Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia
Description
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
Time Frame
Through duration of pregnancy at 12, 20 and 36 week of gestation
Title
Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia
Description
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
Time Frame
Through duration of pregnancy at 12, 20 and 36 week of gestation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig D Scoville, MD,PhD
Phone
208-542-9080
Email
cdscoville@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maritza Rosales
Phone
208-542-9080
Email
maritza@scovilleclinic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig D Scoville, MD, PhD
Organizational Affiliation
Institute of Arthritis Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig D Scoville, MD, PhD
Phone
208-542-9080
Email
cdscoville@yahoo.com
First Name & Middle Initial & Last Name & Degree
Maritza Rosales
Phone
208-542-9080
Email
maritza@scovilleclinic.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data acquired in this project will be shared through presentations at scientific meetings and published peer reviewed publications. In order to disseminate the data, we will maintain a data archive where all information is stored and can be distributed. Data requests may be sent to the PI and reasonable requests will be granted. However a particular data set in the archives will only be shared after a manuscript describing the main findings has been accepted for publication. Also any proprietary information will not be shared until legal restrictions make it permissible
IPD Sharing Time Frame
see Plan Description and no time limit once the data is made available to the public
IPD Sharing Access Criteria
contact Institute of Arthritis Research at scovilleclinic.com

Learn more about this trial

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

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