Navigating Pregnancy and Parenthood With Lyme Disease

Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Parenting; Tick-Borne Diseases; Lyme Disease; Chronic Lyme Disease; Tick-Borne Infections; Post Treatment Lyme Disease
• Intervention / Treatment: Other: Quantitative surveys and qualitative interview

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Meagan E Williams, MSPH, CCRC; Phone Number: 202-476-3388; Email: mewilliams@childrensnational.org
• Study Contact Backup: Name: Sarah B. Mulkey, MD, PhD; Email: sbmulkey@childrensnational.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Hospital
      • Contact: Meagan Williams, MSPH, CCRC; Phone Number: 202-476-3388; Email: mewilliams@childrensnational.org
      • Principal Investigator: Sarah B. Mulkey, MD, PhD
      • Sub-Investigator: Roberta L. DeBiasi, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL	Semi-structured qualitative interviews will be conducted with parents with LD, PTLDS, and/or CL to understand their lived experience. The interviewer will follow a structured interview guide about participants' Lyme disease history, pregnancy, parenting experience, relationships, and their priorities. The interviewer will ask open-ended questions to understand participants' context and allow participants to share what they feel is important to them.	3/20/2024 - 3/1/2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EPDS)	Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) prior to their qualitative interviews. The EPDS is a 10-question standardized postnatal depression screener.	3/20/2024 - 3/1/2025
General Anxiety Disorder-7 (GAD-7)	Participants will complete the General Anxiety Disorder-7 (GAD-7) screener prior to their qualitative interviews. The GAD-7 is a 7-question standardized assessment that measures severity of anxiety symptoms.	3/20/2024 - 3/1/2025
Parenting Stress Index 4th Edition, Short Form (PSI-4 SF)	Participants will complete the Parenting Stress Index 4th Edition, Short Form (PSI-4 SF) prior to their qualitative interviews. The PSI-4 SF is a standardized assessment that measures child and parent characteristics and stress experienced by a parent.	3/20/2024 - 3/1/2025
36-Item Short Form Survey (SF-36)	Participants will complete the36-Item Short Form Survey (SF-36) prior to their qualitative interviews. The SF-36 is a standardized quality of life assessment.	3/20/2024 - 3/1/2025
World Health Organization Disability Assessment Schedule (WHODAS 2.0)	Participants will complete the WHO Disability Assessment Schedule (WHODAS 2.0) prior to their qualitative interviews. The WHODAS 2.0 is a 36-question standardized measure of health and disability.	3/20/2024 - 3/1/2025
Posttraumatic Diagnostic Scale (PDS-5)	Participants will complete a modified version of the Posttraumatic Diagnostic Scale (PDS-5) prior to their qualitative interviews. The PDS-5 is a 24-question standardized measure of posttraumatic stress symptomatology. Participants will answer questions specific to their experience with Lyme disease.	3/20/2024 - 3/1/2025
Positive Affect and Well-Being Scale	Participants will complete the Positive Affect and Well-Being Scale prior to their qualitative interviews. The Positive Affect and Well-Being Scale is a 9-item measure of participants' sense of well-being.	3/20/2024 - 3/1/2025

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Collaborators: Steven & Alexandra Cohen Foundation; Clinical Trials Network for Lyme and Other Tick-Borne Diseases
• Investigators: Principal Investigator: Sarah B. Mulkey, MD, PhD, Children's National Research Institute

Publications and helpful links

Helpful Links

• Participant enrollment screener

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Post-Infectious Disorders; Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Post-Lyme Disease Syndrome; Lyme Disease; Pregnancy Complications; Tick-Borne Diseases
• Other Study ID Numbers: 00000932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No