Navigating Pregnancy and Parenthood With Lyme Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantitative surveys and qualitative interview.
- Who it may be relevant to
- Registry conditions: Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
Overview
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
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.
Interventions
- Other 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.
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Edinburgh Postnatal Depression Scale (EPDS) [Time frame: 3/20/2024 - 3/1/2025]
- General Anxiety Disorder-7 (GAD-7) [Time frame: 3/20/2024 - 3/1/2025]
- Parenting Stress Index 4th Edition, Short Form (PSI-4 SF) [Time frame: 3/20/2024 - 3/1/2025]
- 36-Item Short Form Survey (SF-36) [Time frame: 3/20/2024 - 3/1/2025]
- World Health Organization Disability Assessment Schedule (WHODAS 2.0) [Time frame: 3/20/2024 - 3/1/2025]
- Posttraumatic Diagnostic Scale (PDS-5) [Time frame: 3/20/2024 - 3/1/2025]
- Positive Affect and Well-Being Scale [Time frame: 3/20/2024 - 3/1/2025]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Children's National Hospital — Washington D.C.
Identifiers
NCT: NCT06397794 · 00000932