BDNF Pregnancy Study

NCT ID: NCT01992744

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Pregnant Women

Participants 8 to 12 weeks gestational age as determined by their physician.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah R Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor University of Pennsylvania

Locations

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3701 Market Street

Philadelphia, Pennsylvania, United States

Site Status

Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Penn Center for Women's Behavioral Wellness

Philadelphia, Pennsylvania, United States

Site Status

Penn Medicine Washington Square (PMWS)

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Related Links

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Other Identifiers

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815839

Identifier Type: -

Identifier Source: org_study_id

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