Clinical trial NCT06397794: Navigating Pregnancy and Parenthood With Lyme Disease
Official title: Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lyme Disease
Post Treatment Lyme Disease
Chronic Lyme Disease
Tick-Borne Infections
Tick-Borne Diseases
Pregnancy Complications
Parenting
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Clinical Trials Network for Lyme and Other Tick-Borne Diseases
name: Steven & Alexandra Cohen Foundation
First posted: 2024-05-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll up to 30 participants in this study, all of whom have been pregnant in the past and given birth to at least one liveborn child. There is no limit to the number of children a participant has, age of child(ren), or duration of Lyme-related symptoms.

Brief 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.

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.

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

Primary outcomes:
measure: Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL
timeFrame: 3/20/2024 - 3/1/2025
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 3/20/2024 - 3/1/2025
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 3/20/2024 - 3/1/2025
measure: Parenting Stress Index 4th Edition, Short Form (PSI-4 SF)
timeFrame: 3/20/2024 - 3/1/2025
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 3/20/2024 - 3/1/2025
measure: World Health Organization Disability Assessment Schedule (WHODAS 2.0)
timeFrame: 3/20/2024 - 3/1/2025
measure: Posttraumatic Diagnostic Scale (PDS-5)
timeFrame: 3/20/2024 - 3/1/2025
measure: Positive Affect and Well-Being Scale
timeFrame: 3/20/2024 - 3/1/2025
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Sarah B. Mulkey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: