Navigating Pregnancy and Parenthood With Lyme Disease
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Children's National Research Institute
- Study ID
- NCT06397794
- Status
- Recruiting
Conditions
- Chronic Lyme Disease
- Lyme Disease
- Parenting
- Post Treatment Lyme Disease
- Pregnancy Complications
- Tick-Borne Diseases
- Tick-Borne Infections
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Quantitative surveys and qualitative interview — OTHERAll 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.
Study Details
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.
Key Dates
- Start date
- Mar 20, 2024
- Status verified
- Jul 2025
- Primary completion
- Aug 1, 2025
- Completion
- Aug 1, 2025
Study Design
- Enrollment
- 30 participants (estimated)
Arms
- Arm: Gestational parents with Lyme diseaseParticipants 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.
Primary Outcome Measure
Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL [ Time Frame: 3/20/2024 - 3/1/2025 ]
Central Contacts
- Meagan E Williams, MSPH, CCRC202-476-3388
- Sarah B. Mulkey, MD, PhD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Sarah B. Mulkey, MD, PhD (PRINCIPAL_INVESTIGATOR) Roberta L. DeBiasi, MD, MS (SUB_INVESTIGATOR) |
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