PregSource: Crowdsourcing to Understand Pregnancy

NCT02577536 | Completed

• 1 other identifier: PregSource
• Study Type: observational
• Target: 2,359
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy; Pregnancy Complications; Morning Sickness; Diabetes, Gestational; Placenta Diseases; Birth Weight

Keywords

Pregnancy outcome; Neonatal outcome; Birth weight; Weight gain; Physical disability

Outcome Measures

Primary Outcomes (1)

• Number of women delivering at each gestational week

  Gestational age at pregnancy end date

  Up to 44 weeks gestational age

Secondary Outcomes (4)

• Birthweight of baby

  At delivery

• Maternal weight gain in pregnancy by gestational age

  Up to 44 weeks gestational age

• Number of women without pregnancy complications

  Up to 44 weeks gestational age

• Number of live births

  At birth

Study Arms (1)

1 All Subjects

No interventions

Other: No Interventions

Interventions

No Interventions OTHER

No Interventions will be conducted under this study.

1 All Subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnancy women 18 years of age or older.

You may qualify if:

• Women who are pregnant

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Child Health and Human Development

Bethesda, Maryland, 20892, United States

Location

Related Links

• PregSource home page

MeSH Terms

Conditions

Pregnancy Complications; Morning Sickness; Diabetes, Gestational; Placenta Diseases; Birth Weight; Weight Gain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Body Weight Changes

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 16, 2015
• Study Start: September 25, 2017
• Primary Completion: October 31, 2022
• Study Completion: August 31, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Deposited by August 31, 2023
• Access Criteria: Per NICHD's Data and Specimen Hub (DASH) policy

Locations

US (1)