PregSource: Crowdsourcing to Understand Pregnancy (PregSource)

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

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

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications; Placenta Diseases; Pregnancy; Birth Weight; Diabetes, Gestational; Morning Sickness
• Intervention / Treatment: 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:

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.

• Study Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Stephanie Wilson Archer, MA; Phone Number: 301-496-0430; Email: PregSource@nih.gov
• Study Contact Backup: Name: Sujata Bardhan, PhD; Phone Number: (301) 496-1383; Email: sujata.bardhan@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institute of Child Health and Human Development
      • Contact: Caroline C Signore, MD; Phone Number: 301-496-5577; Email: signorec@mail.nih.gov
      • Contact: Stephanie Wilson Archer, MA; Phone Number: 301-496-0430; Email: archerst@mail.nih.gov
      • Sub-Investigator: Sujata Bardhan, PhD
      • Sub-Investigator: Lisa Kaeser, JD
      • Sub-Investigator: Melissa Parisi, MD PhD
      • Sub-Investigator: Debbie Jae, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All pregnancy women 18 years of age or older.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women delivering at each gestational week	Gestational age at pregnancy end date	Up to 44 weeks gestational age

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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)

Publications and helpful links

Helpful Links

• PregSource home page

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Birth weight; Physical disability; Weight gain; Neonatal outcome; Pregnancy outcome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Diabetes Mellitus; Body Weight; Vomiting; Birth Weight; Pregnancy Complications; Diabetes, Gestational; Placenta Diseases; Morning Sickness
• Other Study ID Numbers: PregSource

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be deposited into the NICHD data repository.