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Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators

Pregnancy Clinical Trial

Official title:
Influence of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on PGE2, MMP-9, MMP-2, TIMP-1 and TIMP-2 Amniotic Fluid Concentrations

Clinical Trial Summary

The aim of the study is to evaluate the effect of vaginal lactoferrin administration on amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two groups of patients will be prospectively enrolled: not treated with lactoferrin and treated with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.

Clinical Trial Description

Pregnant women undergoing genetic amniocentesis within the 16th-18th gestational week will be enrolled at the Obstetric Unit, University of Ferrara.

The selected patients will be randomly assigned to receive a vaginal compound containing 300 mg of lactoferrin 4 hours before amniocentesis or they will be untreated (controls).

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, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02695563
Study type Interventional
Source Università degli Studi di Ferrara
Contact
Status Completed
Phase Phase 2
Start date January 2014
Completion date September 2015
View Details
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