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Completed

NCT Number: NCT05537259

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

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.

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Key information

Conditions

Pregnancy Behavior Mental Health Issue Personal Satisfaction Postpartum Psychological Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

observation group

Other

No intervention; this is an observational study.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

Secondary outcomes

  1. Monthly cortisol levels determined from hair sample

    Time frame: 35 weeks of pregnancy through 2 months postpartum

    1 sample at session 4

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: BUMPP

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 13, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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