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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659969
• Other study ID #: 999916052
• Secondary ID: 16-CH-N052
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2016
• Last updated: May 11, 2016
• Start date: January 2016
• Est. completion date: November 2020

Study information

• Verified date: January 2016
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Sujata Bardhan
• Phone: (301) 496-1383
• Email: sujata.bardhan[@]nih.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Background:

Women have many physical and emotional experiences and changes in behavior when they are pregnant. Researchers want to learn more about what happens to pregnant women. These things can range from morning sickness and sleep changes, to health problems and mood changes. They hope to use this data to improve the health of pregnant women and their babies.

Objectives:

To learn what happens to women physically and emotionally during pregnancy and after they give birth. To understand problems some pregnant women have related to a disability or chronic health problem.

Eligibility:

Pregnant women ages 18 70

Design:

Participants will register themselves online. They will use the PregSource website or app. They will complete an online consent form.

Participants will create an account profile. They will answer questions about their pre-pregnancy health and current pregnancy.

Participants will complete PregSource questionnaires online or by mobile app.

Participants can enter data in a set of health trackers. These are online diaries that capture daily or weekly data. This can be about the participant s weight, nausea symptoms, mood, and sleep.

Once a month, each participant will be notified by email, text, or app. This will have a link to a new questionnaire. That will be relevant to her current week of pregnancy.

Participants may do online games. These show how memory and other skills change over time.

If a participant does not complete her monthly questions, she will get a reminder by email or text.

Participants with special conditions or complications may be asked to complete additional questionnaires.

Description:

Objective

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 subpopulations of women.

Study Population/Eligibility Criteria

Pregnant women age 18 to 70, all races and ethnicities.

Design Type

PregSource: Crowdsourcing to Understand Pregnancy (PregSource) will use a longitudinal, crowd-sourcing, citizen science approach, asking pregnant women regularly and directly about their pregnancies. Participants will enter information throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile applications ( apps ). 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.

Outcome Measures

PregSource is an online research registry for collecting information about the natural history and range of normative experiences of pregnancy from the primary source: pregnant women. It, therefore, does not have specific outcome measures beyond descriptive data on women s experiences and pregnancy outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

• INCLUSION CRITERIA:

Women who are pregnant and over 18 and under 70 years of age.

EXCLUSION CRITERIA:

• Males

• Women who are not pregnant

• Minors under age 18

• Women over the age of 70

• Women who are unable to provide consent for themselves

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	PatientCrossroads	San Mateo	California

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	Women's experiences during pregnancy and pregnancy outcome		ongoing	No