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

Completed

• Conditions: Pregnancy; Postpartum; Mental Health Issue
• Interventions: Other: Observation Group

• Registration Number: NCT05537259
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-27
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-09-11
• Study First Posted: 2022-09-13
• Primary Completion: 2023-11-07
• Study Completion: 2024-02-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation Group	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.

Primary Outcome Measures

Name	Time	Method
Self-report questionnaire measure of manic symptoms (Highs Scale)	35 weeks of pregnancy through 2 months postpartum	Assessed at each of 4 sessions
Mother-infant behavior during 5 min play episode coded using Global Rating Scales	2 months postpartum	Assessed at in-person laboratory session (session 4)
Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale)	35 weeks of pregnancy through 2 months postpartum	Assessed at each of 4 sessions
Self-report questionnaire measure of symptoms of psychosis (subscales of Symptom Checklist-90)	35 weeks of pregnancy through 2 months postpartum	Assessed at each of 4 sessions
Self-report questionnaire measure of anxiety symptoms (Generalized Anxiety Disorder-7)	35 weeks of pregnancy through 2 months postpartum	Assessed at each of 4 sessions
Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development	2 months postpartum	Assessed at in-person laboratory session (session 4)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States