Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2359 participants
OBSERVATIONAL
2017-09-25
2023-08-31
Brief Summary
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More information is available at: https://pregsource.nih.gov
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Detailed Description
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PregSource uses a longitudinal, crowd-sourcing, citizen science approach, asking pregnant women regularly and directly about their pregnancies. Participants enter information throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants will be able to track their pregnancy data over time, print out reports to share with their healthcare team, and view summaries of de-identified data to see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information from partner organizations about pregnancy management, issues, and complications.
Participants may also be a potential pool of recruits for clinical studies. Based on information they enter, eligible women who are interested in participating in clinical studies may be sent contact information about observational or interventional studies. Their contact information will not be shared directly with researchers.
After a critical mass of data is collected, de-identified data will be available to approved researchers for analysis.
If you are pregnant and interested in joining PregSource, please:
1. Go to https://pregsource.nih.gov/.
2. Select "Join" at the top of the page.
3. Complete the questions on the Join page
4. Complete the online consent form.
After that you will be asked some information for your account Profile, and you should start receiving/seeing questionnaires to complete on the My Dashboard page. You can also come in as often as you want/need to to complete PregSource's trackers to tell us about your mood, activity level, sleep, morning sickness, and weight gain. We also have a separate tracker for adding any medications, vitamins, and other supplements you may take during your pregnancy.
More information is available at: https://pregsource.nih.gov. If you have any additional questions, please let us know at [email protected].
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1 All Subjects
No interventions
No Interventions
No Interventions will be conducted under this study.
Interventions
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No Interventions
No Interventions will be conducted under this study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Women who are not pregnant
* Women under 18 years of age or older than 70 years of age
* Women who are unable to provide consent for themselves, and for whom a parent, legal guardian, or legally authorized representative does not provide consent
18 Years
70 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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Principal Investigators
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Caroline C Signore, MD
Role: PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Melissa Parisi, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Locations
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National Institute of Child Health and Human Development
Bethesda, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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PregSource home page
Other Identifiers
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PregSource
Identifier Type: -
Identifier Source: org_study_id
NCT02659969
Identifier Type: -
Identifier Source: nct_alias
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