PregnancyFAPNCT01700374
Happy Mommy! Happy Baby! Study
An observational study of Pregnancy and Stress, Psychological, run by University of Pennsylvania at 4 sites in United States.
Trial summary
The purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies. Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Stress, Psychological, Stress, Physiological
- How many people
- 1,506 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2012to Jul 2022
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women from the greater Philadelphia and surrounding areas who are ages 18 - 45 and between 8 and 17 weeks pregnant will be considered for enrollment into this study. All subjects must be physically healthy without a serious major medical illness, as well as be carrying a healthy fetus. Subjects will be recruited through fliers, advertising, and social media and may be directly approached at a University of Pennsylvania Health System (UPHS) or UPHS affiliated obstetrics and gynecology clinic. We anticipate the composition of the proposed study population to reflect the greater Philadelphia referral base. The projected composition from Philadelphia is African American 42.58%, Hispanic 8.5%, Asian 4.42%, Other 2.04% and White, not of Hispanic Origin, 42.46%. Additionally, we plan to include father's of the babies that are willing and able to complete the ACE questionnaire.
Who may be able to join
- Aged 18 to 45 years;
- Able to give written informed consent;
- Between 8 to 17 weeks at time of recruitment;
- Attendance at 20 week ultrasound at a UPHS site;
- Healthy full term (35 6/7 weeks) infants;
- Fluency in written and spoken English.
Who cannot join
- Presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy;
- Presence of a serious medical or neurological illness, requiring treatment during pregnancy;
- Use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period;
- Drug or alcohol abuse history within previous 2 years;
- Life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder
- Active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist;
Show all 10Show fewer
- Hamilton Depression Rating Scale Score > 14;
- Suicidal ideation within the previous 6 months;
- Use of steroids drugs of antihypertensives during pregnancy as they could alter physiologic arousal;
- A history of preterm birth or history of preterm labor in the active pregnancy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
3701 Market Street
Philadelphia, Pennsylvania, 19104
Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, 19104
Penn Medicine Washington Square (PMWS)
Philadelphia, Pennsylvania, 19107
About this study
Official title: Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response
The purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies.
Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.
Read the detailed description
The objectives of this study are to further our understanding of maternal prepubertal adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to determine the degree of maternal stress and prepubertal adversity, and an acoustic startle paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also utilizes an infant stress test to assess infant arousal.
- Keywords
- pregnancy, stress, psychological, stress, physiological, maternal-fetal relations
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women without Prepubertal Adversity | At 8-17 weeks gestational age, 1,500 pregnant women will complete: * Adverse Childhood Events (ACE) Questionnaire; * Perceived Stress Scale (PSS); * A general health and demographic questionnaire. All women who are screened will be asked if they would be willing to allow the study team to access their delivery report. Women who report 0 or 1 adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort. | |
| Women with Prepubertal Adversity | At 8-17 weeks gestational age, 1,500 pregnant women will complete: * Adverse Childhood Events (ACE) Questionnaire; * Perceived Stress Scale (PSS); * A general health and demographic questionnaire. All women who are screened will be asked if they would be willing to allow the study team to access their delivery report. Women who report 2 or more adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Adrenal Size
The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.
Measured: 20 to 22 weeks gestational age
Secondary outcomes (2)
Physiologic Arousal
The secondary outcomes are physiologic arousal based on the maternal response to the acoustic startle paradigm or TSST plus salivary cortisol at 15-17 weeks gestational age and 6-8 weeks postpartum.
Measured: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum
Physiologic Arousal
The secondary outcomes are physiologic arousal based on infant stress responses as measured by the infant behavioral assessment and salivary cortisol at 6 months postpartum.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 1,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cynthia N Epperson, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700374
- Sponsor's protocol ID
- 812880
- Other IDs
- P50MH099910
- Acronym
- FAP
- Status last verified
- Jan 2023
- First submitted
- 2 Oct 2012
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Morrison KE, Epperson CN, Sammel MD, Ewing G, Podcasy JS, Hantsoo L, Kim DR, Bale TL. Preadolescent Adversity Programs a Disrupted Maternal Stress Reactivity in Humans and Mice. Biol Psychiatry. 2017 Apr 15;81(8):693-701. doi: 10.1016/j.biopsych.2016.08.027. Epub 2016 Aug 26.
PubMed 27776734
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response
- ClinicalTrials.gov ID
- NCT01700374
- Acronym / sponsor ID
- FAP / 812880
- Keywords
- pregnancy, stress, psychological, stress, physiological, maternal-fetal relations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,506 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2012 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 4 Oct 2012 (estimated)
- 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 purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies.
Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.
Detailed description
The objectives of this study are to further our understanding of maternal prepubertal adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to determine the degree of maternal stress and prepubertal adversity, and an acoustic startle paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also utilizes an infant stress test to assess infant arousal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women without Prepubertal Adversity | – | –At 8-17 weeks gestational age, 1,500 pregnant women will complete: * Adverse Childhood Events (ACE) Questionnaire; * Perceived Stress Scale (PSS); * A general health and demographic questionnaire. All women who are screened will be asked if they would be willing to allow the study team to access their delivery report. Women who report 0 or 1 adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort. |
| Women with Prepubertal Adversity | – | –At 8-17 weeks gestational age, 1,500 pregnant women will complete: * Adverse Childhood Events (ACE) Questionnaire; * Perceived Stress Scale (PSS); * A general health and demographic questionnaire. All women who are screened will be asked if they would be willing to allow the study team to access their delivery report. Women who report 2 or more adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women from the greater Philadelphia and surrounding areas who are ages 18 - 45 and between 8 and 17 weeks pregnant will be considered for enrollment into this study. All subjects must be physically healthy without a serious major medical illness, as well as be carrying a healthy fetus. Subjects will be recruited through fliers, advertising, and social media and may be directly approached at a University of Pennsylvania Health System (UPHS) or UPHS affiliated obstetrics and gynecology clinic. We anticipate the composition of the proposed study population to reflect the greater Philadelphia referral base. The projected composition from Philadelphia is African American 42.58%, Hispanic 8.5%, Asian 4.42%, Other 2.04% and White, not of Hispanic Origin, 42.46%. Additionally, we plan to include father's of the babies that are willing and able to complete the ACE questionnaire.
Key inclusion criteria (6 listed)
- Aged 18 to 45 years;
- Able to give written informed consent;
- Between 8 to 17 weeks at time of recruitment;
- Attendance at 20 week ultrasound at a UPHS site;
- Healthy full term (35 6/7 weeks) infants;
Key exclusion criteria (10 listed)
- Presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy;
- Presence of a serious medical or neurological illness, requiring treatment during pregnancy;
- Use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period;
- Drug or alcohol abuse history within previous 2 years;
- Life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal Adrenal Size
Time frame: 20 to 22 weeks gestational age
The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.
2 secondary outcomes
Physiologic Arousal
Time frame: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum
Physiologic Arousal
Time frame: 6 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 6 Jan 2023.
- Results publication: PubMed 27776734Morrison KE, Epperson CN, Sammel MD, Ewing G, Podcasy JS, Hantsoo L, Kim DR, Bale TL. Preadolescent Adversity Programs a Disrupted Maternal Stress Reactivity in Humans and Mice. Biol Psychiatry. 2017 Apr 15;81(8):693-701. doi: 10.1016/j.biopsych.2016.08.027. Epub 2016 Aug 26.
- Program WebsiteLink provided by the sponsor.
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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.
Cynthia N Epperson, M.D. principal investigator
University of Pennsylvania
4 sites 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 Stress, Psychological, run by University of Pennsylvania at 4 sites 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 6 inclusion and 10 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Fetal Adrenal Size (time frame: 20 to 22 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700374, which also lists 1 linked publication.
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 6 Jan 2023.