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Vaccine

Tdap Vaccination Timing for Preeclampsia

Phase 4

Waitlist Available

Led By Craig D Scoville, MD, PhD

Research Sponsored by Institute of Arthritis Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 42

Be between 18 and 65 years old

Must not have

No history of cancer in past 5 years prior to this study (except for non-melanoma localized skin cancers or cancer in situ)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through duration of pregnancy approximately 10 months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial could reduce the incidence of preeclampsia, a common and severe complication of pregnancy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects of the Tdap vaccine may include pain at injection site, mild fever, fatigue, headache, nausea, diarrhea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 42 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had any cancer except for non-dangerous skin cancer or localized cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through duration of pregnancy approximately 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through duration of pregnancy approximately 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through duration of pregnancy approximately 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pre-Eclampsia

Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination

Secondary study objectives

Assessment of other potential risk factors for preeclampsia inclusive of BMI, hypertension, prior history of preeclampsia, first pregnancy

Other study objectives

Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 2Eligibility criteria met