PregSource: Crowdsourcing to Understand Pregnancy

Pregnancy Clinical Trial

— PregSource  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577536
• Other study ID #: PregSource
• Status: Completed
• Start date: September 25, 2017
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2024
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Other known NCT identifiers

• NCT02659969

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2359
• Est. completion date: August 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No Interventions
No Interventions will be conducted under this study.

Locations

Country	Name	City	State
United States	National Institute of Child Health and Human Development	Bethesda	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women delivering at each gestational week	Gestational age at pregnancy end date	Up to 44 weeks gestational age
Secondary	Birthweight of baby	Birthweight of babies born >20 weeks gestational age	At delivery
Secondary	Maternal weight gain in pregnancy by gestational age	Maternal weight gain in pregnancy by gestational age	Up to 44 weeks gestational age
Secondary	Number of women without pregnancy complications	Pregnancy complications including: gestational diabetes, preeclampsia, placenta previa, etc.)	Up to 44 weeks gestational age
Secondary	Number of live births	Number of infants born alive	At birth

External Links

•   PregSource home page