PregnancyBUMPPNCT05537259
BUMPP: A Study to Better Understand Mood During the Perinatal Period
An observational study of Pregnancy and Postpartum, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Postpartum, Mental Health Issue
- What is being tested?
- Observation Group
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant women and their infants
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- Observation Group
- Keywords
- Pregnancy, Postpartum, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation GroupOther
No intervention; this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale)
Assessed at each of 4 sessions
Measured: 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
Measured: 35 weeks of pregnancy through 2 months postpartum
Self-report questionnaire measure of manic symptoms (Highs Scale)
Assessed at each of 4 sessions
Measured: 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
Measured: 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)
Measured: 2 months postpartum
Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development
Assessed at in-person laboratory session (session 4)
Measured: 2 months postpartum
Secondary outcomes (2)
Monthly cortisol levels determined from hair sample
1 sample at session 4
Measured: 35 weeks of pregnancy through 2 months postpartum
Cytokine levels determined from finger prick blood spot
3 samples (sessions 1, 2, and 4)
Measured: 35 weeks of pregnancy through 2 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start27 Jun 2022
- Primary completion7 Nov 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Gunnar, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537259
- Sponsor's protocol ID
- CEHD-2023-31101
- Acronym
- BUMPP
- Status last verified
- Jan 2025
- First submitted
- 6 Jul 2022
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BUMPP: A Study to Better Understand Mood During the Perinatal Period
- ClinicalTrials.gov ID
- NCT05537259
- Acronym / sponsor ID
- BUMPP / CEHD-2023-31101
- Conditions
- Pregnancy, Postpartum, Mental Health Issue
- Keywords
- Pregnancy, Postpartum, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Group | – | Other: Observation GroupResearchers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women and their infants
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation GroupNo intervention; this is an observational study. | Other | Observation Group |
Primary outcome
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
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
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
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
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)
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 secondary outcomes
Monthly cortisol levels determined from hair sample
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Gunnar, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Postpartum, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale) (time frame: 35 weeks of pregnancy through 2 months postpartum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.