BUMPP: A Study to Better Understand Mood During the Perinatal Period (BUMPP)

November 15, 2023 updated by: University of Minnesota
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and their infants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation Group
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.
Other: Observation Group
No intervention; this is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale)
Time Frame: 35 weeks of pregnancy through 2 months postpartum
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)
Time Frame: 35 weeks of pregnancy through 2 months postpartum
Assessed at each of 4 sessions
35 weeks of pregnancy through 2 months postpartum
Self-report questionnaire measure of manic symptoms (Highs Scale)
Time Frame: 35 weeks of pregnancy through 2 months postpartum
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)
Time Frame: 35 weeks of pregnancy through 2 months postpartum
Assessed at each of 4 sessions
35 weeks of pregnancy through 2 months postpartum
Mother-infant behavior during 5 min play episode coded using Global Rating Scales
Time Frame: 2 months postpartum
Assessed at in-person laboratory session (session 4)
2 months postpartum
Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development
Time Frame: 2 months postpartum
Assessed at in-person laboratory session (session 4)
2 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly cortisol levels determined from hair sample
Time Frame: 35 weeks of pregnancy through 2 months postpartum
1 sample at session 4
35 weeks of pregnancy through 2 months postpartum
Cytokine levels determined from finger prick blood spot
Time Frame: 35 weeks of pregnancy through 2 months postpartum
3 samples (sessions 1, 2, and 4)
35 weeks of pregnancy through 2 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Megan Gunnar, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Actual)

November 7, 2023

Study Completion (Estimated)

November 7, 2024

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

September 11, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 31077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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