1600 Participants Needed

Tdap Vaccination Timing for Preeclampsia

CD
MR
Overseen ByMaritza Rosales
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Institute of Arthritis Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Research Team

CD

Craig D Scoville, MD, PhD

Principal Investigator

Institute of Arthritis Research

Eligibility Criteria

This trial is for pregnant women aged 18-42, confirmed at week 12, who are willing to get the Tdap vaccine at either week 28 or week 36 and follow study procedures. They must sign informed consent and have no history of allergic reactions to Tdap or cancer (except certain skin cancers) in the past five years.

Inclusion Criteria

I am willing to get the Tdap vaccine at week 28 or 36.
Confirmed pregnancy at week 12
Willing to participate and sign informed consent documentation
See 1 more

Exclusion Criteria

No history of allergic reaction or intolerance to Tdap vaccination
I haven't had any cancer except for non-dangerous skin cancer or localized cancer in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Randomization and Baseline

Participants are randomized to receive Tdap vaccination at either week 28 or week 36 and baseline data is collected

12 weeks
1 visit (in-person)

Treatment

Participants receive Tdap vaccination at either week 28 or week 36, with placebo given at the alternate week

8 weeks
3 visits (in-person) at weeks 28, 36, and 2 weeks postpartum

Follow-up

Participants are monitored for the development of preeclampsia and fetal health outcomes

10 months
Routine clinic visits throughout pregnancy

Treatment Details

Interventions

  • Tdap Vaccine
Trial Overview The study is testing if getting a Tdap vaccination earlier in pregnancy (week 28) versus later (week 36) can reduce the risk of developing preeclampsia, which affects maternal and fetal health.
Participant Groups
2Treatment groups
Active Control
Group I: Tdap vaccinations at gestational week 36Active Control1 Intervention
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
Group II: Tdap vaccinations at gestational week 28Active Control1 Intervention
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

Tdap Vaccine is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Tdap Vaccine for:
  • Pertussis prevention in newborns
  • Tetanus prevention
  • Diphtheria prevention
🇨🇦
Approved in Canada as Tdap Vaccine for:
  • Pertussis prevention in newborns
  • Tetanus prevention
  • Diphtheria prevention
🇪🇺
Approved in European Union as Tdap Vaccine for:
  • Pertussis prevention in newborns
  • Tetanus prevention
  • Diphtheria prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Institute of Arthritis Research

Lead Sponsor

Trials
1
Recruited
1,600+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials
123
Recruited
42,400+

Brigham Young University

Collaborator

Trials
23
Recruited
10,200+
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