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

NCT05537259 | Completed

• 1 other identifier: CEHD-2023-31101
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Postpartum; Mental Health Issue

Keywords

Pregnancy; Postpartum; Mental Health

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Observation Group OTHER

No intervention; this is an observational study.

Observation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their infants

You may qualify if:

• years or older
• weeks pregnant or less
• carrying only one baby (not twins or triplets)
• first time giving birth
• can speak/read/write in English

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Megan Gunnar, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: September 13, 2022
• Study Start: June 27, 2022
• Primary Completion: November 7, 2023
• Study Completion: February 20, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)