Exploring pregnancy and parenting experiences in individuals with Lyme disease
Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
Children's National Research Institute · NCT06397794
This study looks at how having Lyme disease affects pregnancy and parenting experiences for those diagnosed with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Children's National Research Institute (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06397794 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the unique experiences of pregnancy and parenting among individuals diagnosed with Lyme disease, post-treatment Lyme disease syndrome, or chronic Lyme disease. Participants will complete quantitative surveys covering their medical history, child development, and demographics, followed by qualitative interviews to delve deeper into their personal experiences. The goal is to understand how these conditions affect their perinatal experiences and parenting challenges. This mixed methods approach aims to highlight the differences faced by these individuals compared to healthy peers.
Who should consider this trial
Good fit: Ideal candidates are individuals over 18 years old, residing in the U.S. or Canada, who have been diagnosed with Lyme disease or related conditions during or before pregnancy.
Not a fit: Patients who have never been diagnosed with Lyme disease or have not experienced pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve support and care for pregnant individuals with Lyme disease.
How similar studies have performed: While there may be limited studies specifically addressing pregnancy and parenting in the context of Lyme disease, the mixed methods approach has been successful in other chronic conditions, suggesting potential for valuable findings here.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Children's National Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Principal investigator: Sarah B. Mulkey, MD, PhD — Children's National Research Institute
- Study coordinator: Meagan E Williams, MSPH, CCRC
- Email: mewilliams@childrensnational.org
- Phone: 202-476-3388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections, Tick-Borne Diseases, Pregnancy Complications, Parenting