Phospholipase A2 Producing Bacteria and Pre-Term Labor

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.

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Charleston Area Medical Center/West Virginia University

Charleston, West Virginia, 25304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Mar 4, 2009
Registry last updated: Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed