Phospholipase A2 Producing Bacteria and Pre-Term Labor

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. Identifier: NCT00855543
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : July 15, 2011
Information provided by:
CAMC Health System

Brief Summary:
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 or disease
Preterm Labor

Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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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

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 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

Responsible Party: Dr. Byron C. Calhoun, M.D., Charleston Area Medical Center/West Virginia University Identifier: NCT00855543     History of Changes
Other Study ID Numbers: 08-11-2097
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011

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