Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397794
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Navigating Pregnancy and Parenthood With Lyme Disease
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor chronic Lyme CL either during or before a prior pregnancy Participants will complete quantitative surveys on topics such as their medical history their childrens 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 children 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 LDPTLDSCL will experience unique challenges related to pregnancy experiences in medical care settings and their childs 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 eg 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 LDPTLDSCL including specific questions about navigating the health care system information seeking behaviors and their childs development
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 LDPTLDSCL will experience unique challenges related to pregnancy experiences in medical care settings and their childs 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 eg 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 LDPTLDSCL including specific questions about navigating the health care system information seeking behaviors and their childs development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None