Pre-EclampsiaPhase 4NCT04424693
Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36
A Phase 4 study testing Tdap Vaccine Administration in people with Pre-Eclampsia and Diphtheria, Tetanus and Pertussis Vaccine Reaction, run by Institute of Arthritis Research at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Diphtheria, Tetanus and Pertussis Vaccine Reaction
- What is being tested?
- Tdap Vaccine Administration
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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) -
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Craig D Scoville, MD, PhD, 208-542-9080, cdscoville@yahoo.com
Maritza Rosales, 208-542-9080, maritza@scovilleclinic.com
About this study
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
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.
Read the 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.
- Being tested
- Tdap Vaccine Administration
- Keywords
- Preeclampsia, Tdap vaccinations
- Medical subject headings
- Pre-Eclampsia, Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tdap Vaccine AdministrationDrug
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%
| Study group | Role | What they receive |
|---|---|---|
| Tdap vaccinations at gestational week 28 | Active comparator | 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 Receives: Drug: Tdap Vaccine Administration |
| Tdap vaccinations at gestational week 36 | Active comparator | 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 Receives: Drug: Tdap Vaccine Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through duration of pregnancy approximately 10 months
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
Measured: Through duration of pregnancy approximately 10 months
Secondary outcomes (1)
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
Measured: Through duration of pregnancy approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Arthritis Research
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans, Brigham Young University
- Responsible party
- Sponsor
- Investigators
- Craig D Scoville, MD, PhD, Principal investigator, Institute of Arthritis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424693
- Sponsor's protocol ID
- PE-Tdap01
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04424693
- Acronym / sponsor ID
- PE-Tdap01
- Keywords
- Preeclampsia, Tdap vaccinations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Institute of Arthritis ResearchUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans, Brigham Young University
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tdap vaccinations at gestational week 28 | Active comparator | Drug: Tdap Vaccine AdministrationPregnant 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 |
| Tdap vaccinations at gestational week 36 | Active comparator | Drug: Tdap Vaccine AdministrationPregnant 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 |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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) -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tdap Vaccine AdministrationTdap 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% | Drug | Tdap vaccinations at gestational week 28, Tdap vaccinations at gestational week 36 |
Primary outcome
Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination
Time frame: Through duration of pregnancy approximately 10 months
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
Time frame: Through duration of pregnancy approximately 10 months
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
1 secondary outcome
Assessment of other potential risk factors for preeclampsia inclusive of BMI, hypertension, prior history of preeclampsia, first pregnancy
Time frame: Through duration of pregnancy approximately 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Yes. 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
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig D Scoville, MD, PhD principal investigator
Institute of Arthritis Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tdap Vaccine Administration in people with Pre-Eclampsia and Diphtheria, Tetanus and Pertussis Vaccine Reaction, run by Institute of Arthritis Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig D Scoville, MD,PhD (208-542-9080, cdscoville@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination (time frame: Through duration of pregnancy approximately 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.