Baby Bump Lifestyle Intervention Supplement Study

Gestational Diabetes Clinical Trial

— Baby BLISS  

Official title:

Baby Bump Lifestyle Intervention Supplement Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03751813
• Other study ID #: Baby BLISS
• Status: Terminated
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Dietary Supplement:
• Supplement
Supplement will be given to this group to take daily for 8 weeks

Locations

Country	Name	City	State
United States	SUNY Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower blood stress markers via venous draw	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.	9 months