NCT05537259|Completed
BUMPP: A Study to Better Understand Mood During the Perinatal Period
BUMPP
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BUMPP
Sponsor study identifier
observational
168
1 country
1
Study Start
June 27, 2022
Actual (reported)Primary Completion
November 7, 2023
Actual (reported)Study Completion
February 20, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 20, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 27, 2022
Actual (reported)July 6, 2022
Actual (reported)September 13, 2022
Actual (reported)November 7, 2023
Actual (reported)February 20, 2024
Actual (reported)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
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
Self-report questionnaire measure of manic symptoms (Highs Scale)
Assessed at each of 4 sessions
35 weeks of pregnancy through 2 months postpartum
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
Monthly cortisol levels determined from hair sample
35 weeks of pregnancy through 2 months postpartum
Cytokine levels determined from finger prick blood spot
35 weeks of pregnancy through 2 months postpartum
Researchers will collect data on maternal mental health symptoms, as well as health and psychosocial factors, via short interviews (sessions 1 and 4) and via self-report questionnaires completed through REDCap at each session. Participating women will also provide one small hair sample (session 4) for measurement of the stress hormone cortisol and several finger stick blood spot samples (sessions 1,2, and 4) for measurement of immune markers.
No intervention; this is an observational study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pregnant women and their infants
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Megan Gunnar, PhD
University of Minnesota
168 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2022
First Posted
September 13, 2022
Study Start
June 27, 2022
Actual (reported)Mother-infant behavior during 5 min play episode coded using Global Rating Scales
Assessed at in-person laboratory session (session 4)
2 months postpartum
Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development
Assessed at in-person laboratory session (session 4)
2 months postpartum
Contact the study team to confirm eligibility.
Primary Completion
November 7, 2023
Actual (reported)Study Completion
February 20, 2024
Actual (reported)Last Updated
January 13, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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