Happy Mommy! Happy Baby! Study (FAP)
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Purpose
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.
| Condition |
|---|
|
Pregnancy Stress, Psychological Stress, Physiological Maternal-fetal Relations |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response |
- Fetal Adrenal Size [ Time Frame: 20 to 22 weeks gestational age ] [ Designated as safety issue: No ]The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.
- Physiologic Arousal [ Time Frame: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum ] [ Designated as safety issue: No ]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.
- Physiologic Arousal [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
- Salivary cortisol;
- Blood plasma Corticotropin-releasing Hormone (CRH).
| Estimated Enrollment: | 1500 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Women without Prepubertal Adversity
At 8-17 weeks gestational age, 1,500 pregnant women will complete:
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 do not list any adverse childhood events 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:
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 indicate increased childhood adversity will be invited to continue in the study as part of the Women with Prepubertal Adversity cohort. We aim to have 125 women in this cohort. |
Detailed Description:
The purpose of this study is to evaluate the impact of maternal psychosocial stress and physiologic arousal on fetal adrenal gland volume across pregnancy. Maternal stress may have an adverse impact on the developing fetus by causing abnormal programming of the fetal Hypothalamic-pituitary-adrenal (HPA) axis which could lead to medical and behavioral health problems later in life. Non-invasive measurements of fetal adrenal gland volume by 3-D ultrasound may allow us to understand if maternal stress can impact fetal adrenal gland size. In addition, the investigators can begin to discern whether fetal adrenal size has behavioral ramifications for the offspring through assessment of the infants HPA axis response to novelty. This study presents a non-invasive, novel approach to understanding the impact of maternal stress on fetal and infant developments.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women from the greater Philadelphia and surrounding areas who are ages 18 to 45 and between 8 to 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. Subject will be enrolled through OB/GYN waiting room recruiting, fliers, advertisements and social media outlets.
Inclusion Criteria:
- 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;
- Either No ACEs or at least 2 ACEs;
- Healthy full term (35 6/7 weeks) infants;
- Fluency in written and spoken English.
Exclusion Criteria:
- 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 features and bipolar disorder;
- Active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist;
- Hamilton Depression Rating Scale Score of 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01700374
| Contact: Jessica L Snell, M.S. | (215) 573-8880 | jessnell@mail.med.upenn.edu |
| United States, Pennsylvania | |
| 3701 Market Street | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jessica L Snell, M.S. 215-573-8880 jessnell@mail.med.upenn.edu | |
| Contact: Claudia Iannelli, M.S. (215) 417-8839 sclaud@mail.med.upenn.edu | |
| Principal Investigator: Deborah R Kim, M.D. | |
| Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jessica L Snell, M.S. 215-573-8880 jessnell@mail.med.upenn.edu | |
| Contact: Claudia Iannelli, M.S. (215) 417-8839 sclaud@mail.med.upenn.edu | |
| Principal Investigator: Deborah R Kim, M.D. | |
| Penn Center for Women's Behavioral Wellness | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jessica L Snell, M.S. 215-573-8880 jessnell@mail.med.upenn.edu | |
| Contact: Claudia Iannelli, M.S. (215) 417-8839 sclaud@mail.med.upenn.edu | |
| Principal Investigator: Deborah R Kim, M.D. | |
| Penn Medicine Washington Square (PMWS) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Jessica L Snell, M.S. 215-573-8880 jessnell@mail.med.upenn.edu | |
| Contact: Claudia Iannelli, M.S. (215) 417-8839 sclaud@mail.med.upenn.edu | |
| Principal Investigator: Deborah R Kim, M.D. | |
| Principal Investigator: | Deborah R Kim, M.D. | Assistant Professor University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01700374 History of Changes |
| Other Study ID Numbers: | 812880, P50MH099910 |
| Study First Received: | October 2, 2012 |
| Last Updated: | December 8, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
pregnancy stress, psychological stress, physiological maternal-fetal relations |
Additional relevant MeSH terms:
|
Stress, Psychological Behavioral Symptoms |
ClinicalTrials.gov processed this record on February 27, 2015