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 Details — Status: Completed

Administrative data

• NCT number: NCT02695563
• Other study ID #: PRUa1GR-2013-00000220
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2016
• Last updated: March 3, 2016
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton gestation

• maternal age as indication to fetal karyotyping

Exclusion Criteria:

• consumption of drugs interfering with the immune system

• previous miscarriages

• pregnancy at risk for maternal or fetal disease

• lactose intolerance

Study Design

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Lactoferrin

Locations

Country	Name	City	State
Italy	Obstetric Unit, University of Ferrara	Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of inflammatory markers in the amniotic fluid	The investigator will measure the amniotic fluid concentration of Prostaglandin E2(PGE2), active MMP(Matrix Metalloproteinase)-9, active MMP-2, TIMP(Tissue Inhibitor of Matrix Metalloproteinase)-1 and TIMP-2 by commercially available ELISA or activity assay systems; concentration of creatinine in the amniotic fluids will be measured by the alkaline picrate method. Controls and Lactoferrin-treated patients will be compared by parametric or non-parametric statistical tests.	1 month after the enrollment of patients will be concluded.	No