POWERMOM, A Healthy Pregnancy Research Community

April 15, 2024 updated by: Scripps Translational Science Institute
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Research Translational Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven R. Steinhubl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women, 16 years or older, who currently live in the United States, and own a smartphone.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve our understanding of healthy pregnancy weight gain for all women.
Time Frame: Up to 46 weeks.
Weight (lbs.) will be collected using surveys and measured with home and medical office scales.
Up to 46 weeks.
Improve our understanding of how different factors impact pregnancy complications.
Time Frame: Up to 46 weeks.
Pregnancy complications will be collected using surveys.
Up to 46 weeks.
Improve our understanding how different factors impact the birth of the baby.
Time Frame: Up to 46 weeks.
Birth outcomes will be collected using surveys.
Up to 46 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Estimated)

March 13, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-17-6924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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