Recruiting

Lyme Disease

Sponsor:

Children's National Research Institute

Code:

NCT06397794

Conditions

Lyme Disease

Post Treatment Lyme Disease

Chronic Lyme Disease

Tick-Borne Infections

Tick-Borne Diseases

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quantitative surveys and qualitative interview

Study Details

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

Study ID

NCT06397794

Start date

Mar 20, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Meagan E Williams, MSPH, CCRC

202-476-3388mewilliams@childrensnational.org

Sarah B. Mulkey, MD, PhD

sbmulkey@childrensnational.org

Locations

Children's National Hospital

Recruiting

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

Contacts

Meagan Williams, MSPH, CCRC

202-476-3388mewilliams@childrensnational.org

Principal Investigator:

Sarah B. Mulkey, MD, PhD

More Information

Sponsor

Children's National Research Institute

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-06-17.