Baby Bump Lifestyle Intervention Supplement Study

Not Applicable

Terminated

• Conditions: Gestational Diabetes

• Registration Number: NCT03751813
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2019-03-21
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
lower blood stress markers via venous draw	9 months	We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies.

Trial Locations

Locations (1)

SUNY Buffalo; 🇺🇸 Buffalo, New York, United States