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Gestational parents with Lyme disease for Tick-borne Diseases

N/A
Recruiting
Led By Sarah B. Mulkey, MD, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3/20/2024 - 3/1/2025
Awards & highlights
No Placebo-Only Group

Summary

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.

Eligible Conditions
  • Tick-Borne Diseases
  • Tick-borne Diseases
  • Lyme Disease
  • Pregnancy Complications
  • Parenting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3/20/2024 - 3/1/2025
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3/20/2024 - 3/1/2025 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL
Secondary study objectives
36-Item Short Form Survey (SF-36)
Edinburgh Postnatal Depression Scale (EPDS)
General Anxiety Disorder-7 (GAD-7)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gestational parents with Lyme diseaseExperimental Treatment1 Intervention
Participants in this study will be enrolled following a screening call to assess their eligibility. All participants must report that they were diagnosed with acute Lyme disease, PTLDS, and/or Chronic Lyme by a health care provider while they were pregnant OR PTLDS/CL prior to becoming pregnant with ongoing symptoms during pregnancy. After being consented for the study, participants will then complete a set of online questionnaires and participate in a qualitative interview with a member of the research team.

Find a Location

Who is running the clinical trial?

Clinical Trials Network for Lyme and Other Tick-Borne DiseasesUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
Children's National Research InstituteLead Sponsor
220 Previous Clinical Trials
258,140 Total Patients Enrolled
Steven & Alexandra Cohen FoundationOTHER
8 Previous Clinical Trials
272 Total Patients Enrolled
~11 spots leftby Mar 2025
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