PregSource: Crowdsourcing to Understand Pregnancy

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT02577536

Collaborator

(none)

100,000

Enrollment

Location

48.2

Anticipated Duration (Months)

2076.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Pregnancy Complications Morning Sickness Diabetes, Gestational Placenta Diseases Birth Weight	Other: No Interventions

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:

Go to https://pregsource.nih.gov/.
Select "Join" at the top of the page.
Complete the questions on the Join page
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PregSource: Crowdsourcing to Understand Pregnancy, Observations of Daily Living From Pregnant Women

Actual Study Start Date :

Sep 25, 2017

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
1 All Subjects No interventions	Other: No Interventions No Interventions will be conducted under this study.

Arm

Intervention/Treatment

1 All Subjects

No interventions

Other: No Interventions

No Interventions will be conducted under this study.

Outcome Measures

Primary Outcome Measures

Number of women delivering at each gestational week [Up to 44 weeks gestational age]
Gestational age at pregnancy end date

Secondary Outcome Measures

Birthweight of baby [At delivery]
Birthweight of babies born >20 weeks gestational age
Maternal weight gain in pregnancy by gestational age [Up to 44 weeks gestational age]
Maternal weight gain in pregnancy by gestational age
Number of women without pregnancy complications [Up to 44 weeks gestational age]
Pregnancy complications including: gestational diabetes, preeclampsia, placenta previa, etc.)
Number of live births [At birth]
Number of infants born alive

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Child Health and Human Development	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator: Caroline C Signore, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Melissa Parisi, MD PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)