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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

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE March 1, 2016
Last Update Posted Date March 4, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators
Official Title  ICMJE Influence of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on PGE2, MMP-9, MMP-2, TIMP-1 and TIMP-2 Amniotic Fluid Concentrations
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pregnancy
Intervention  ICMJE Drug: Lactoferrin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Lactoferrin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2016)
111
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02695563
Other Study ID Numbers  ICMJE PRUa1GR-2013-00000220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alessandro Trentini, Università degli Studi di Ferrara
Study Sponsor  ICMJE Università degli Studi di Ferrara
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carlo Contini, Professor Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara
PRS Account Università degli Studi di Ferrara
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP