Phospholipase A2 Producing Bacteria and Pre-Term Labor

Phospholipase A2 Producing Bacteria, Age at Gestation, Cervical Length Measurement and the Incidence of Pre-Term Labor

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.

Study Overview

• Status: Completed
• Conditions: Preterm Labor

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center/West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Obstetric patients in West Virginia

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Byron C Calhoun, MD, West Virginia Univeristy/Charleston Area Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 3, 2009
• First Submitted That Met QC Criteria: March 3, 2009
• First Posted (Estimate): March 4, 2009

Study Record Updates

• Last Update Posted (Estimate): July 15, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: 08-11-2097