Pregnancy Clinical Trial
Official title:
PregSource: Crowdsourcing to Understand Pregnancy Observations of Daily Living From Pregnant Women
Background:
Women have many physical and emotional experiences and changes in behavior when they are
pregnant. Researchers want to learn more about what happens to pregnant women. These things
can range from morning sickness and sleep changes, to health problems and mood changes. They
hope to use this data to improve the health of pregnant women and their babies.
Objectives:
To learn what happens to women physically and emotionally during pregnancy and after they
give birth. To understand problems some pregnant women have related to a disability or
chronic health problem.
Eligibility:
Pregnant women ages 18 70
Design:
Participants will register themselves online. They will use the PregSource website or app.
They will complete an online consent form.
Participants will create an account profile. They will answer questions about their
pre-pregnancy health and current pregnancy.
Participants will complete PregSource questionnaires online or by mobile app.
Participants can enter data in a set of health trackers. These are online diaries that
capture daily or weekly data. This can be about the participant s weight, nausea symptoms,
mood, and sleep.
Once a month, each participant will be notified by email, text, or app. This will have a
link to a new questionnaire. That will be relevant to her current week of pregnancy.
Participants may do online games. These show how memory and other skills change over time.
If a participant does not complete her monthly questions, she will get a reminder by email
or text.
Participants with special conditions or complications may be asked to complete additional
questionnaires.
Objective
To better understand the range of physical and emotional experiences and alterations in
behavior that women have during pregnancy and after giving birth, the impact of these
experiences on women s lives, and the perinatal challenges encountered by special
subpopulations of women.
Study Population/Eligibility Criteria
Pregnant women age 18 to 70, all races and ethnicities.
Design Type
PregSource: Crowdsourcing to Understand Pregnancy (PregSource) will use a longitudinal,
crowd-sourcing, citizen science approach, asking pregnant women regularly and directly about
their pregnancies. Participants will enter information throughout gestation and the early
infancy of their babies into online surveys and trackers via a website and/or mobile
applications ( apps ). 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.
Outcome Measures
PregSource is an online research registry for collecting information about the natural
history and range of normative experiences of pregnancy from the primary source: pregnant
women. It, therefore, does not have specific outcome measures beyond descriptive data on
women s experiences and pregnancy outcomes.
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