Pregnancy Clinical Trial
— BUMPPOfficial title:
BUMPP: A Study to Better Understand Mood During the Perinatal Period
Verified date | November 2023 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.
Status | Active, not recruiting |
Enrollment | 168 |
Est. completion date | November 7, 2024 |
Est. primary completion date | November 7, 2023 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older - 35 weeks pregnant or less - carrying only one baby (not twins or triplets) - first time giving birth - can speak/read/write in English Exclusion Criteria: - major medical health condition like a heart, kidney, or liver disease or HIV - currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this research study - have regularly used alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis) |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | |
Primary | Self-report questionnaire measure of anxiety symptoms (Generalized Anxiety Disorder-7) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | |
Primary | Self-report questionnaire measure of manic symptoms (Highs Scale) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | |
Primary | Self-report questionnaire measure of symptoms of psychosis (subscales of Symptom Checklist-90) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | |
Primary | Mother-infant behavior during 5 min play episode coded using Global Rating Scales | Assessed at in-person laboratory session (session 4) | 2 months postpartum | |
Primary | Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development | Assessed at in-person laboratory session (session 4) | 2 months postpartum | |
Secondary | Monthly cortisol levels determined from hair sample | 1 sample at session 4 | 35 weeks of pregnancy through 2 months postpartum | |
Secondary | Cytokine levels determined from finger prick blood spot | 3 samples (sessions 1, 2, and 4) | 35 weeks of pregnancy through 2 months postpartum |
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