Happy Mommy! Happy Baby! Study (FAP)

This study is currently recruiting participants.

See

Contacts and Locations

Verified September 2016 by University of Pennsylvania

Sponsor:

ClinicalTrials.gov Identifier:

NCT01700374

First Posted: October 4, 2012

Last Update Posted: September 2, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

University of Pennsylvania

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

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Physiologic Arousal [ Time Frame: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum ]
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 ]
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: 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 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: 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 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.

Groups/Cohorts

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 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:

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 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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 Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700374

Contacts


Contact: Jessica L Snell, M.S.	(215) 573-8880	jessnell@mail.med.upenn.edu

Locations


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.

Sponsors and Collaborators

University of Pennsylvania

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Deborah R Kim, M.D.	Assistant Professor University of Pennsylvania

More Information

Additional Information:

Program Website This link exits the ClinicalTrials.gov site


Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01700374 History of Changes
Other Study ID Numbers:	812880 P50MH099910 ( U.S. NIH Grant/Contract )
First Submitted:	October 2, 2012
First Posted:	October 4, 2012
Last Update Posted:	September 2, 2016
Last Verified:	September 2016

Keywords provided by University of Pennsylvania:


pregnancy stress, psychological stress, physiological maternal-fetal relations

Additional relevant MeSH terms:


Stress, Psychological Behavioral Symptoms

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