Phospholipase A2 Producing Bacteria and Pre-Term Labor

C

CAMC Health System

Status

Completed

Conditions

Preterm Labor

Study type

Observational

Funder types

Other

Identifiers

NCT00855543
08-11-2097

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

14 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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