BDNF Pregnancy Study

Pregnancy Clinical Trial

— BDNF  

Official title:

Peripheral Serum BDNF Levels and Poor Birth Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992744
• Other study ID #: 815839
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: May 29, 2015
• Start date: May 2012
• Est. completion date: April 2015

Study information

• Verified date: October 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	3701 Market Street	Philadelphia	Pennsylvania
United States	Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Center for Women's Behavioral Wellness	Philadelphia	Pennsylvania
United States	Penn Medicine Washington Square (PMWS)	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Birth Outcomes	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)	Postpartum (30 days postpartum)	No
Primary	Neuropeptide & Blood Levels	BDNF; Complete blood count (CBC)	First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum)	No
Secondary	Clinician and Patient Ratings	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)	First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum)	No

External Links

•   Program Website