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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through duration of pregnancy approximately 10 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 42 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pre-Eclampsia

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

Secondary outcome measures

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

Other outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Institute of Arthritis ResearchLead Sponsor

Louisiana State University Health Sciences Center in New OrleansOTHER

114 Previous Clinical Trials

42,601 Total Patients Enrolled

Brigham Young UniversityOTHER

22 Previous Clinical Trials

8,622 Total Patients Enrolled

Media Library

Tdap Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04424693 — Phase 4

Pre-eclampsia Research Study Groups: Tdap vaccinations at gestational week 36, Tdap vaccinations at gestational week 28

Pre-eclampsia Clinical Trial 2023: Tdap Vaccine Highlights & Side Effects. Trial Name: NCT04424693 — Phase 4

Tdap Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04424693 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens eligible to join this experiment?

"This investigation has established that only participants aged between 18-42 are eligible, whereas there are 14 studies available for minors and 46 trials open to seniors."

Answered by AI

Could I potentially qualify for participation in this research initiative?

"The prerequisites for this study necessitate that participants have been diagnosed with pre-eclampsia and are aged between 18 to 42. Approximately 1600 individuals will be accepted as test subjects in the trial."

Answered by AI

Are any openings still available for participants in this research study?

"According to clinicaltrials.gov, the recruitment period of this particular medical trial has already passed; however, there are still 88 other studies actively seeking participants. The study was initially uploaded on December 1st 2020 and last updated June 11th 2020."

Answered by AI