Trial record 12 of 266 for:    infant health | Open Studies | NIH

Happy Mommy! Happy Baby! Study (FAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01700374
First received: October 2, 2012
Last updated: May 8, 2014
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

  • 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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700374

Contacts
Contact: Lisa C Lamprou, B.A. (215) 573-8880 llamprou@mail.med.upenn.edu
Contact: Katie Zagrabbe, M.D. Candidate (215) 573-8878 zagrabbe@mail.med.upenn.edu

Locations
United States, Pennsylvania
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: Kathryn Czarkowski, M.A.    (215) 573-8882    kczar@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: Kathryn Czarkowski    (215) 573-8882    kczar@mail.med.upenn.edu   
Principal Investigator: Deborah R Kim, M.D.         
3701 Market Street Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica L Snell, M.S.    215-573-8880    jessnell@mail.med.upenn.edu   
Contact: Kathryn Czarkowski    (215) 573-8882    kczar@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: Kathryn Czarkowski    (215) 573-8882    kczar@mail.med.upenn.edu   
Principal Investigator: Deborah R Kim, M.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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: May 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 August 28, 2014