Status:
TERMINATED
Baby Bump Lifestyle Intervention Supplement Study
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.
Eligibility Criteria
Inclusion
- Pregnant woman presenting to her first obstetrical visit for this pregnancy
- Must be in the first trimester (\<13 weeks)
- 18 years or older
- High-stress levels as measured by the Perceived Stress Level Questionnaire
- Must be a single pregnancy (e.g. not twins, triplets, etc.)
Exclusion
- Diabetes (types 1 and 2)
- Diagnosis of gestational diabetes in prior pregnancy
- Hyperemesis gravidarum or severe morning sickness that interferes with supplement intake
- Major medical illnesses including but not limited to: malabsorption syndromes (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and other major autoimmune conditions
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03751813
Start Date
March 21 2019
End Date
November 30 2019
Last Update
February 20 2020
Active Locations (1)
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1
SUNY Buffalo
Buffalo, New York, United States, 14214