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Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications

Pregnancy Clinical Trial

Clinical Trial Summary

Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.

Clinical Trial Description

60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one) respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays panel technology.

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02843984
Study type Interventional
Source Università degli Studi di Ferrara
Contact
Status Completed
Phase N/A
Start date March 2011
Completion date March 2012
View Details
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