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CompletedNCT02577536PregSourceUpdated May 7, 2024

PregSource: Crowdsourcing to Understand Pregnancy

An observational study in Pregnancy, Pregnancy Complications and Morning Sickness, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,359
Ages
18 Years to 70 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

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

Keywords

  • Pregnancy outcome
  • Neonatal outcome
  • Birth weight
  • Weight gain
  • Physical disability
03

In context

Pregnancy Complications

437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.

This study's enrollment of 2,359 is above the median of 320 across 205 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All pregnancy women 18 years of age or older.

Inclusion criteria

  • Women who are pregnant

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,359 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 1 All Subjects

    No interventions

    Other: No Interventions

Interventions

  • OtherNo Interventions

    No Interventions will be conducted under this study.

06

What researchers measure

Primary outcomes

  1. Number of women delivering at each gestational week

    Gestational age at pregnancy end date

    Time frame: Up to 44 weeks gestational age

Secondary outcomes

  1. Birthweight of baby

    Birthweight of babies born \>20 weeks gestational age

    Time frame: At delivery

  2. Maternal weight gain in pregnancy by gestational age

    Maternal weight gain in pregnancy by gestational age

    Time frame: Up to 44 weeks gestational age

  3. Number of women without pregnancy complications

    Pregnancy complications including: gestational diabetes, preeclampsia, placenta previa, etc.)

    Time frame: Up to 44 weeks gestational age

  4. Number of live births

    Number of infants born alive

    Time frame: At birth

07

Study locations

1 site
  • National Institute of Child Health and Human Development
    Bethesda, Maryland 20892, United States
08

References and documents

Study documents

  • Study protocol · Dec 8, 2015
  • Informed consent form · Dec 8, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data will be deposited into the NICHD data repository.

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02577536
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Oct 16, 2015
Start date
Sep 25, 2017
Primary completion
Oct 31, 2022
Completion
Aug 31, 2023
Last update
May 7, 2024

Study contacts

Caroline C Signore, MD
principal investigator · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Melissa Parisi, MD PhD
principal investigator · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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