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

Pregnancy Clinical Trial

— BUMPP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05537259
• Other study ID #: 31077
• Status: Active, not recruiting
• Start date: June 27, 2022
• Est. completion date: November 7, 2024

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: November 7, 2024
• Est. primary completion date: November 7, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Health Issue
• Postpartum
• Pregnancy

Intervention

Other:
• Observation Group
No intervention; this is an observational study.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Self-report questionnaire measure of manic symptoms (Highs Scale)	Assessed at each of 4 sessions	35 weeks of pregnancy through 2 months postpartum
Primary	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
Primary	Mother-infant behavior during 5 min play episode coded using Global Rating Scales	Assessed at in-person laboratory session (session 4)	2 months postpartum
Primary	Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development	Assessed at in-person laboratory session (session 4)	2 months postpartum
Secondary	Monthly cortisol levels determined from hair sample	1 sample at session 4	35 weeks of pregnancy through 2 months postpartum
Secondary	Cytokine levels determined from finger prick blood spot	3 samples (sessions 1, 2, and 4)	35 weeks of pregnancy through 2 months postpartum