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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02695563
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Alessandro Trentini, Università degli Studi di Ferrara

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Lactoferrin Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
No Intervention: controls
The patients will be not treated with vaginal lactoferrin
Active Comparator: Lactoferrin
The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.
Drug: Lactoferrin



Primary Outcome Measures :
  1. Measurement of inflammatory markers in the amniotic fluid [ Time Frame: 1 month after the enrollment of patients will be concluded. ]
    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.



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695563


Locations
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Italy
Obstetric Unit, University of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
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Study Director: Carlo Contini, Professor Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alessandro Trentini, PhD, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT02695563    
Other Study ID Numbers: PRUa1GR-2013-00000220
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alessandro Trentini, Università degli Studi di Ferrara:
Amniocentesis
Additional relevant MeSH terms:
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Lactoferrin
Anti-Infective Agents