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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

Tracking Information
First Submitted Date October 30, 2013
First Posted Date November 25, 2013
Last Update Posted Date June 1, 2015
Study Start Date May 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2013)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 19, 2013)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2013)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title BDNF Pregnancy Study
Official Title Peripheral Serum BDNF Levels and Poor Birth Outcomes
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
- Brain-Derived Neurotrophic Factor
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.
Condition Pregnancy
Intervention Not Provided
Study Groups/Cohorts Healthy Pregnant Women
Participants 8 to 12 weeks gestational age as determined by their physician.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 29, 2015)
32
Original Estimated Enrollment
 (submitted: November 19, 2013)
100
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01992744
Other Study ID Numbers 815839
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Deborah R Kim, M.D. Assistant Professor University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date October 2013