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Therapeutic Areas: Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Women's Health
Location: United States, NY

Clinical Trial Details

Overview

Research Study Summary

Mechanisms Underlying Preterm Birth in Minority Women NIH Grant R01NR010552-01A1

Purpose

The overall objective of this study is to decrease preterm birth (PTB) in minority women. Mechanisms underlying preterm birth will be explicated by developing a prognostic model of PTB in African American (AA) women at 22-24 weeks, a period of periviability, and validating the model in Mexican American (MA) women. Additionally, in AA women, who are most at risk for early PTB (<32 weeks gestation), mechanisms underlying preterm labor and PTB will be explicated. As only 40-50% of preterm labor ends in PTB, understanding factors that differentiate preterm labor from PTB is vital in improving care of preterm labor and in preventing preterm birth. To meet the specific aims of this study we will:

Specific Aim 1: In African-American women experiencing uncomplicated pregnancies examine the predictive ability at 22-24 weeks gestation of stress (perceived stress, racism, CRH), depression, coping behaviors, immune function (vaginal cytokines), health behaviors (BMI and smoking), and infection (including Chlamydia, gonorrhea, and bacterial vaginosis), in differentiating those African-American women who will deliver preterm, from those who will deliver at term, by building a prognostic model.

Specific Aim 2: In African-American women experiencing early preterm labor (between 22-32 weeks gestation) examine the predictive ability of stress (perceived stress, racism, CRH), depression, coping behaviors, immune function (vaginal and cervical cytokines), infection (including Chlamydia, gonorrhea and bacterial vaginosis), and health behaviors (smoking, BMI, nutritional intake) in differentiating those African-American women who will deliver preterm from those who will deliver at term by building a prognostic model.

Specific Aim 3: Examine the timing and contribution of factors including stress (perceived stress and CRH), depression, coping behaviors, immune function (vaginal and cervical cytokines), infection ( including Chlamydia, gonorrhea and bacterial vaginosis), and health behaviors (smoking, BMI and nutritional intake) between the onset of preterm labor (or 22-24 weeks of gestation for women who do not experience preterm labor) to delivery outcome in three groups of African-American women (those who: 1) labor and deliver prematurely, 2) labor prematurely but deliver at term and 3) experience only term labor and delivery).

A. Objective: Looking to compare the differences in preterm birth in minority populations which will create 3 sub groups:

  • Preterm labor - preterm delivery (PTL - PTD)
  • Preterm labor - term delivery (PTL - TD)
  • Term labor - term delivery (TL - TD)

The portion of evaluation in the Labor & Delivery triage unit will be looking at the sub groups a. (PTL - PTD) and b (PTL - TD). The 3rd subgroup will be evaluated through the outpatient prenatal care clinic.

Patient Inclusion Criteria:

  • Any pregnant woman who identifies herself as being Black, African American or Caribbean American will be eligible for study inclusion.
  • Pregnancy care will be at Jacobi Medical Center, Bronx, NY.
  • Gestational age 22 - 32 weeks
  • Singleton gestation
  • True preterm labor and therefore eligible for this study she must be experiencing:
    • Uterine contractions occurring between 22 - 32 completed weeks gestation (Gestational age determined by a combination of last menstrual period, physical assessment, and ultrasound findings) occurring at least a rate of four in 20 minutes
    • Uterine contractions will be associated with evidence of a change in the position, consistency, length and/or dilatation of the cervix

Patient Exclusion Criteria:

  • Adolescents under age18 years
  • Inability to read English or Spanish
  • Known uterine or cervical abnormalities
  • Multiple gestations: twin or triplet gestations
  • Kidney disease, pyelonephritis in the current pregnancy, or chronic hypertension;
  • Known heart disease, coronary artery disease, history of peripartum cardiomyopathy;
  • Known autoimmune disorders: lupus (SLE), antiphospholipid syndrome (APS)
  • Type 1 or Type 2 diabetics or gestational diabetics (GDM) on insulin
  • Known asthma requiring use of steroid inhaler
  • Preeclampsia at time of data collection
  • Oral steroid use one month prior to the time of enrollment
  • Known congenital fetal anomalies as determined on fetal ultrasound, especially those leading to polyhydramnios, trisomies, major structural anomalies such as neural tube defects, ventral wall defects, congenital heart disease)
  • Known blood group isoimmunization
  • Active cervico-vaginal bleeding or known placenta previa

To Learn more
Gender

Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

David J. Garry, DO, Department of OB/GYN and Women's Health
The Harold & Muriel Block Institute for Clinical and Translational Research at Einstein & Montefiore
Jacobi Medical Center
1400 Pelham Parkway South
Bronx, NY 10461
Phone: 718-918-6300
Fax: 718-918-6318

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CW ID: 154636

Date Last Changed: July 24, 2013


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