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Phospholipase A2 Producing Bacteria and Pre-Term Labor

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 4, 2009
Last Update Posted: July 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CAMC Health System
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.

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obstetric patients in West Virginia

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855543

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

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
First Submitted: March 3, 2009
First Posted: March 4, 2009
Last Update Posted: July 15, 2011
Last Verified: July 2011

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