Phospholipase A2 Producing Bacteria and Pre-Term Labor

This study has been completed.
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00855543
First received: March 3, 2009
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to better understand (1) if phospholipase A2 producing microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing bacteria than a pregnant adults and (3) if there is a difference in the cytokines between pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may trigger the onset of premature labor. The following are hypothesized: (a) The microorganism cultured should show high activities of phospholipase A2 (b) The cervical length measurement predictive value should correspond to the gestation age at term (c) Vaginal flora of teen will be more susceptible to colonization with higher phospholipase A2 producing bacteria than that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4, IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is different in the production of inflammatory cytokines and modulators(e) The maternal genotype of teens therefore influences the production of phospholipase A2 and causes an increase in preterm delivery.


Condition
Preterm Labor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phospholipase A2 Producing Bacteria, Age at Gestation, Cervical Length Measurement and the Incidence of Pre-Term Labor

Further study details as provided by CAMC Health System:

Estimated Enrollment: 60
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obstetric patients in West Virginia

Criteria

Inclusion Criteria:

  1. Gestational age <34 weeks
  2. Singleton gestation
  3. Urinalysis and urine culture collected via clean catch
  4. Age range 14 - 45
  5. Patient receiving prenatal care at CAMC Women's Medicine Center

Exclusion Criteria:

  1. In labor or with uterine contractions
  2. Known fetal anomalies
  3. Cerclage
  4. Dark amniotic fluid suggestive of previous bleeding
  5. Multiple gestation
  6. Known unbalance chromosomal complement
  7. Pregnant patient with prior history of excisional cervical biopsy (either cold knife, loop electrosurgical excision procedure, or laser conization)
  8. Patient with mullerian anomaly
  9. Patient with 2 or more D&E secondary to spontaneous or induced abortion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855543

Locations
United States, West Virginia
Charleston Area Medical Center/West Virginia University
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Byron C Calhoun, MD West Virginia Univeristy/Charleston Area Medical Center
  More Information

No publications provided

Responsible Party: Dr. Byron C. Calhoun, M.D., Charleston Area Medical Center/West Virginia University
ClinicalTrials.gov Identifier: NCT00855543     History of Changes
Other Study ID Numbers: 08-11-2097
Study First Received: March 3, 2009
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014