Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-03-20
2025-08-01
Brief Summary
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Detailed Description
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Participants may be included in this study if they report having received a diagnosis of Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), or chronic Lyme (CL) and they have given birth to at least one liveborn child. The investigators hypothesize that patients with LD/PTLDS/CL will experience unique challenges related to pregnancy, experiences in medical care settings, and their child's development.
Enrolled participants will complete a brief set of online quantitative questionnaires on topics such as their demographic characteristics, family information, Lyme disease histories, and mental health. The investigators will report on these data to illustrate similarities and differences between participants in the study for potentially relevant factors (e.g., timing of Lyme diagnosis relative to pregnancy, symptoms, mental health concerns). The questionnaires will be followed by an in-depth qualitative interview in English with each participant to learn about their experiences related to pregnancy and parenting with LD/PTLDS/CL, including specific questions about navigating the health care system, information seeking behaviors, and their child's development.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Gestational parents with Lyme disease
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.
Quantitative surveys and qualitative interview
All participants will complete online surveys on topics including demographic and socioeconomic information, medical history (parent and child), pregnancy history, and mental health and well-being. They will then participate in a qualitative interview about their pregnancy and parenting experiences as gestational parents with Lyme disease.
Interventions
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Quantitative surveys and qualitative interview
All participants will complete online surveys on topics including demographic and socioeconomic information, medical history (parent and child), pregnancy history, and mental health and well-being. They will then participate in a qualitative interview about their pregnancy and parenting experiences as gestational parents with Lyme disease.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Live outside of the United States or Canada
* Never been diagnosed with Lyme disease by a medical provider
* Never been pregnant
* Never given birth to a liveborn infant
* Previously participated in a qualitative study about their experience with Lyme disease
* Do not want to agree to having their interviews audio recorded
18 Years
FEMALE
No
Sponsors
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Clinical Trials Network for Lyme and Other Tick-Borne Diseases
UNKNOWN
Steven & Alexandra Cohen Foundation
OTHER
Children's National Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sarah B. Mulkey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Participant enrollment screener
Other Identifiers
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00000932
Identifier Type: -
Identifier Source: org_study_id
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