BDNF Pregnancy Study

Completed

• Conditions: Pregnancy

• Registration Number: NCT01992744
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Status Verified: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropeptide & Blood Levels	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

Name	Time	Method
Clinician and Patient Ratings	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)

Trial Locations

Locations (4)

3701 Market Street; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Medicine Washington Square (PMWS); 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Center for Women's Behavioral Wellness; 🇺🇸 Philadelphia, Pennsylvania, United States

Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States