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Completed

NCT Number: NCT01992744

BDNF Pregnancy Study

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.

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Key information

Conditions

Pregnancy

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

3701 Market Street, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Peripheral Serum BDNF Levels and Poor Birth Outcomes

Acronym: BDNF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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