Lyme DiseaseNCT06397794
Navigating Pregnancy and Parenthood With Lyme Disease
An observational study of Lyme Disease and Post Treatment Lyme Disease, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease
- What is being tested?
- Quantitative surveys and qualitative interview
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah B. Mulkey, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Meagan Williams, MSPH, CCRC, 202-476-3388, mewilliams@childrensnational.org
Sarah B. Mulkey, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections, Tick-Borne Diseases, Pregnancy Complications
- Being tested
- Quantitative surveys and qualitative interview
- Medical subject headings
- Lyme Disease, Post-Lyme Disease Syndrome, Tick-Borne Diseases, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative surveys and qualitative interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quantitative surveys and qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3/20/2024 - 3/1/2025
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3/20/2024 - 3/1/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start20 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Network for Lyme and Other Tick-Borne Diseases, Steven & Alexandra Cohen Foundation
- Responsible party
- Sponsor
- Investigators
- Sarah B. Mulkey, MD, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397794
- Sponsor's protocol ID
- 00000932
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
- ClinicalTrials.gov ID
- NCT06397794
- Acronym / sponsor ID
- 00000932
- Conditions
- Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections, Tick-Borne Diseases, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Clinical Trials Network for Lyme and Other Tick-Borne Diseases, Steven & Alexandra Cohen Foundation
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational parents with Lyme disease | – | Other: Quantitative surveys and qualitative interviewParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative surveys and qualitative interviewAll 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. | Other | Gestational parents with Lyme disease |
Primary outcome
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
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.
7 secondary outcomes
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 3/20/2024 - 3/1/2025
General Anxiety Disorder-7 (GAD-7)
Time frame: 3/20/2024 - 3/1/2025
Parenting Stress Index 4th Edition, Short Form (PSI-4 SF)
Time frame: 3/20/2024 - 3/1/2025
36-Item Short Form Survey (SF-36)
Time frame: 3/20/2024 - 3/1/2025
World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: 3/20/2024 - 3/1/2025
Posttraumatic Diagnostic Scale (PDS-5)
Time frame: 3/20/2024 - 3/1/2025
Positive Affect and Well-Being Scale
Time frame: 3/20/2024 - 3/1/2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Participant enrollment screenerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah B. Mulkey, MD, PhD contact
Sarah B. Mulkey, MD, PhD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease and Post Treatment Lyme Disease, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meagan E Williams, MSPH, CCRC (202-476-3388, mewilliams@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.