Phospholipase A2 Producing Bacteria and Pre-Term Labor

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855543
• Other study ID #: 08-11-2097
• Status: Completed
• Phase: N/A
• First received: March 3, 2009
• Last updated: July 14, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labor

Locations

Country	Name	City	State
United States	Charleston Area Medical Center/West Virginia University	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States,