Navigating Pregnancy and Parenthood With Lyme Disease

NCT06397794 | Recruiting

• 1 other identifier: 00000932
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Edinburgh Postnatal Depression Scale (EPDS)

  3/20/2024 - 3/1/2025

• General Anxiety Disorder-7 (GAD-7)

  3/20/2024 - 3/1/2025

• Parenting Stress Index 4th Edition, Short Form (PSI-4 SF)

  3/20/2024 - 3/1/2025

• 36-Item Short Form Survey (SF-36)

  3/20/2024 - 3/1/2025

• World Health Organization Disability Assessment Schedule (WHODAS 2.0)

  3/20/2024 - 3/1/2025

Study Arms (1)

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

Interventions

Quantitative surveys and qualitative interview 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.

Gestational parents with Lyme disease

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• Clinical Trials Network for Lyme and Other Tick-Borne Diseases: collaborator
• Steven & Alexandra Cohen Foundation: collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Related Links

• Participant enrollment screener

MeSH Terms

Conditions

Lyme Disease; Post-Lyme Disease Syndrome; Tick-Borne Diseases; Pregnancy Complications

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sarah B. Mulkey, MD, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meagan E Williams, MSPH, CCRC

CONTACT

202-476-3388; mewilliams@childrensnational.org

Sarah B. Mulkey, MD, PhD

CONTACT

sbmulkey@childrensnational.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: March 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)