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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03085875
Other study ID # IRB-17-6924
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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