Phospholipase A2 Producing Bacteria and Pre-Term Labor

NCT00855543 | Completed

• 1 other identifier: 08-11-2097
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obstetric patients in West Virginia

You may qualify if:

• Gestational age \<34 weeks
• Singleton gestation
• Urinalysis and urine culture collected via clean catch
• Age range 14 - 45
• Patient receiving prenatal care at CAMC Women's Medicine Center

You may not qualify if:

• In labor or with uterine contractions
• Known fetal anomalies
• Cerclage
• Dark amniotic fluid suggestive of previous bleeding
• Multiple gestation
• Known unbalance chromosomal complement
• Pregnant patient with prior history of excisional cervical biopsy (either cold knife, loop electrosurgical excision procedure, or laser conization)
• Patient with mullerian anomaly
• Patient with 2 or more D\&E secondary to spontaneous or induced abortion

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center/West Virginia University

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Byron C Calhoun, MD

  West Virginia Univeristy/Charleston Area Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 15, 2011

Record last verified: 2011-07

Locations

US (1)