Navigating Pregnancy and Parenthood With Lyme Disease

NCT ID: NCT06397794

Last Updated: 2025-07-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-20

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Patients with chronic conditions may experience the perinatal period and the experience of parenting differently than their healthy peers. The purpose of this study is to understand the lived experiences of pregnancy and parenting among gestational parents with Lyme disease.

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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Lyme Disease Post Treatment Lyme Disease Chronic Lyme Disease Tick-Borne Infections Tick-Borne Diseases Pregnancy Complications Parenting

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Over 18 years of age and reside in the United States or Canada
* 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

* Under 18 years of age
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinical Trials Network for Lyme and Other Tick-Borne Diseases

UNKNOWN

Sponsor Role collaborator

Steven & Alexandra Cohen Foundation

OTHER

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Meagan E Williams, MSPH, CCRC

Role: CONTACT

202-476-3388

Sarah B. Mulkey, MD, PhD

Role: CONTACT

Facility Contacts

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Meagan Williams, MSPH, CCRC

Role: primary

202-476-3388

Related Links

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Other Identifiers

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00000932

Identifier Type: -

Identifier Source: org_study_id

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