Clinical trial NCT02577536: PregSource: Crowdsourcing to Understand Pregnancy
Official title: PregSource: Crowdsourcing to Understand Pregnancy, Observations of Daily Living From Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Pregnancy Complications
Morning Sickness
Diabetes, Gestational
Placenta Diseases
Birth Weight
Keywords: Pregnancy outcome
Neonatal outcome
Birth weight
Weight gain
Physical disability
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2015-10-16
Enrollment: 2359
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnancy women 18 years of age or older.

Brief summary: PregSource uses a crowd-sourcing approach, asking pregnant women to enter information regularly and directly about their pregnancies 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 can track their data over time, print out reports to share with their healthcare team, and see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information about pregnancy management, issues, and complications.

More information is available at: https://pregsource.nih.gov

Detailed description: The objective of PregSource: Crowdsourcing to Understand Pregnancy (PregSource) is: 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 sub-populations of women.

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 pregsource@nih.gov.

Eligibility criteria: Inclusion Criteria:

* Women who are pregnant

Exclusion Criteria:

* Males
* 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

Primary outcomes:
measure: Number of women delivering at each gestational week
timeFrame: Up to 44 weeks gestational age
Secondary outcomes:
measure: Birthweight of baby
timeFrame: At delivery
measure: Maternal weight gain in pregnancy by gestational age
timeFrame: Up to 44 weeks gestational age
measure: Number of women without pregnancy complications
timeFrame: Up to 44 weeks gestational age
measure: Number of live births
timeFrame: At birth
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Child Health and Human Development
state: Maryland
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Caroline C Signore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Melissa Parisi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: