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POWERMOM, A Healthy Pregnancy Research Community

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03085875
Collaborator
(none)
100,000
Enrollment
1
Location
124.5
Anticipated Duration (Months)
803.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world health research to answer questions important to a broad population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Eligibility determined, Individuals enrolled and consented to join study

    • Short Intake Survey (demographic and baseline health information collected)

    • Health History Survey (two days after participant enrolls in the study)

    • Survey questions about current health and medical history will be sent to participants weekly. If participants had a prenatal visit during the week, a few additional questions will be asked.

    • Twins / Multiples survey will begin appearing when a participant indicates they are having more than one baby

    • Participants can submit home measurements of, weight and blood pressure as frequently as they want through HealthKit.

    • Pregnancy outcome variables. (Miscarriage, stillbirth, birth of healthy baby, or pregnancy ended) will also be asked weekly.

    • If the baby is born, questions about labor and delivery, as well as weight, size and birth date of the baby will be asked. A reminder to fill out the outcome survey will be given 4 weeks after a user's due date.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    POWERMOM, A Healthy Pregnancy Research Community
    Actual Study Start Date :
    Mar 16, 2017
    Anticipated Primary Completion Date :
    Mar 13, 2027
    Anticipated Study Completion Date :
    Jul 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Improve our understanding of healthy pregnancy weight gain for all women. [Up to 46 weeks.]

      Weight (lbs.) will be collected using surveys and measured with home and medical office scales.

    2. Improve our understanding of how different factors impact pregnancy complications. [Up to 46 weeks.]

      Pregnancy complications will be collected using surveys.

    3. Improve our understanding how different factors impact the birth of the baby. [Up to 46 weeks.]

      Birth outcomes will be collected using surveys.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adults, 16 years of age or older

    • Pregnant women or within 8 weeks postpartum

    • Currently live within the United States

    • Own, and comfortable using, a smartphone or tablet

    Exclusion Criteria:

    • Inability to consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Research Translational Institute La Jolla California United States 92037

    Sponsors and Collaborators

    • Scripps Translational Science Institute

    Investigators

    • Principal Investigator: Lase Ajayi, MD, The Scripps Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Scripps Translational Science Institute
    ClinicalTrials.gov Identifier:
    NCT03085875
    Other Study ID Numbers:
    • IRB-17-6924
    First Posted:
    Mar 21, 2017
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Scripps Translational Science Institute
    Weight Change
    Healthy Pregnancy
    Physiologic Sensors
    Additional relevant MeSH terms:
    Body Weight Changes

    Study Results

    No Results Posted as of Dec 3, 2021