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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05537259
Other study ID # 31077
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 27, 2022
Est. completion date November 7, 2024

Study information

Verified date November 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation Group
No intervention; this is an observational study.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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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