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BDNF Pregnancy Study (BDNF)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992744
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

The purpose of this study is to evaluate the correlation between varying levels of neuropeptides and birth outcomes. Neuropeptides are substances (proteins) produced in the body in very small amounts but without which the nervous system cannot function properly, and which might have a role in the health of a newborn. As part of this study, we are collecting blood samples from pregnant women.

Neuropeptides and hormones can be measured in blood. This study will involve three blood draws from the participants arm. Demographic information will also be requested, and participants will be asked to complete questionnaires about their mood and personal experiences at each visit.

Our hypothesis is that participants with lower levels of brain-derived neurotrophic factor (BDNF) will be at increased risk for poor birth outcomes.


Condition or disease
Pregnancy

Detailed Description:

This prospective, non-randomized trial will evaluate peripheral serum blood levels of BDNF in participants recruited from previously identified University of Pennsylvania obstetrics and gynecological (OB/GYN) clinics. A total of 100 pregnant subjects will be recruited consecutively and evaluated in the first and third trimester of their pregnancy as well as within a month after delivery.

The entire project will take one year.

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peripheral Serum BDNF Levels and Poor Birth Outcomes
Study Start Date : May 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Group/Cohort
Healthy Pregnant Women
Participants 8 to 12 weeks gestational age as determined by their physician.



Primary Outcome Measures :
  1. Neuropeptide & Blood Levels [ Time Frame: First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum) ]
    • BDNF
    • Complete blood count (CBC)


Secondary Outcome Measures :
  1. Clinician and Patient Ratings [ Time Frame: First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum) ]
    • Edinburgh Postnatal Depression Score (EPDS)
    • Perceived Stress Scale Score (PSS)
    • Adverse Childhood Events Questionnaire Score (ACEs)
    • Beck Depression Inventory (BDI)
    • Brief Anxiety Inventory (BAI)
    • Brief Symptom Inventory (BSI)


Other Outcome Measures:
  1. Birth Outcomes [ Time Frame: Postpartum (30 days postpartum) ]
    • Birth weight (low birth weight < 2.5 kg; very low birth weight < 1.5 kg)
    • APGAR score (at one minute, at five minutes)
    • Preterm birth (before 37 weeks gestation; very early preterm birth, before 35 weeks gestation); gestational age at delivery
    • Infant mortality/ Neonatal Intensive Care Unit (NICU) Admission
    • Major congenital malformations (especially neurologic)
    • Head circumference (cm)


Biospecimen Retention:   Samples With DNA
- Brain-Derived Neurotrophic Factor


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 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 39 and between 8 to 12 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:

  • Participants must be at least 18 years old and being treated at an outpatient OB/GYN clinic;
  • At least 8 weeks pregnant;
  • Capable of giving informed consent.

Exclusion Criteria:

  • Participants younger than 18 years of age;
  • History of preterm birth;
  • Psychiatric medications during current pregnancy;
  • Participants with a history of hematologic disorders;
  • Participants who refuse informed consent.

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): NCT01992744


Locations
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United States, Pennsylvania
3701 Market Street
Philadelphia, Pennsylvania, United States, 19104
Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, United States, 19104
Penn Medicine Washington Square (PMWS)
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Deborah R Kim, M.D. Assistant Professor University of Pennsylvania
Additional Information:
Publications:
Kim DR, Gonzalez JM, Sammel MD, Parry S, Epperson CN. Brain Derived Neurotrophic Factor is Altered in Human Pregnancy. Clinical Neuropsychiatry 2012 Dec; 9(6):207-11.

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01992744    
Other Study ID Numbers: 815839
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: October 2013
Keywords provided by University of Pennsylvania:
pregnancy
brain-derived neurotrophic factor
birth outcomes