Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Recruiting
Observational Study
Lyme Disease
Post-Treatment Lyme Disease
Chronic Lyme Disease
Tick-Borne Infections
Pregnancy Complications
Child Development
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 40 (estimated)
- Sponsor
- Children's National Research Institute · Other
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About This Trial
The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* English speaker
* Currently reside in the United States or Canada
* Meet CDC criteria for: (1) clinical and/or laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR (2) clinical diagnosis of PTLDS/Chronic Lyme within 3 years of current pregnancy
* Able…
Contacts