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

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: NCT02843984
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Alessandro Trentini, Università degli Studi di Ferrara

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

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Lactoferrin Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
No Intervention: A - untreated
The patients will be not treated with vaginal lactoferrin
Active Comparator: B - 4 hrs treatment
The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.
Drug: Lactoferrin
Active Comparator: C - 12 hrs treatment
The patients will be administered with a single dose of 300 mg vaginal lactoferrin 12 hours prior to mid-trimester genetic amniocentesis.
Drug: Lactoferrin



Primary Outcome Measures :
  1. Amniotic fluid concentration of mediators involved in inflammation [ Time Frame: 1 month after the enrollment of patients will be concluded. ]
    The investigator will measure the amniotic fluid concentration of 47 mediators (cytokines, chemokines and growth factors) involved in the inflammatory process by Luminex multiplex immunoassays. 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 physiological pregnancy;
  • maternal age as the only indication to foetal karyotyping

Exclusion Criteria:

  • assumption of drugs interfering with the immune system;
  • previous miscarriages;
  • pregnancy at risk for maternal or foetal 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): NCT02843984


Locations
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Italy
Obstetric Unit, University of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
Università degli Studi di Ferrara
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Responsible Party: Alessandro Trentini, PhD, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT02843984    
Other Study ID Numbers: PRUa1GR-2013-00000220-B
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 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