Phospholipase A2 Producing Bacteria and Pre-Term Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta

NCT01279369

TERMINATED

Prenatal Sonographic Prediction of Placental Histology and Function

NCT06022458

Pregnancy Complications

RECRUITING

The Role of Cytokines in Apparently Normal Pregnancies

NCT01098214

Pregnancy

WITHDRAWN

Direct Measurements of Cervical Remodeling for Predicting Preterm Birth

NCT01175551

Preterm Birth

COMPLETED

Protein and Ultrasound Indicators of Preterm Birth

NCT01412931

Preterm Birth

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes