POWERMOM, A Healthy Pregnancy Research Community

Pregnancy Related Clinical Trial

Official title:

POWERMOM, A Healthy Pregnancy Research Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085875
• Other study ID #: IRB-17-6924
• Status: Recruiting
• Start date: March 16, 2017
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2024
• Source: Scripps Translational Science Institute
• Contact: Lase Ajayi, MD
• Phone: (858) 554-5734
• Email: tajayi[@]scripps.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: July 31, 2027
• Est. primary completion date: March 13, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Body Weight Changes
• Health Problems in Pregnancy
• Pregnancy Related
• Weight Change, Body

Locations

Country	Name	City	State
United States	Scripps Research Translational Institute	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   This study is being conducted online through the MyDataHelps app, study code PWRMOM