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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00855543
Other study ID # 08-11-2097
Secondary ID
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


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, 

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