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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00855543

Enrollment

Registered

2009-03-04

Start date

2009-08-01

Completion date

2010-12-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of spontaneous preterm birth	From enrollment during pregnancy until birth

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORByron C Calhoun, MD

West Virginia Univeristy/Charleston Area Medical Center

Outcome results