Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications
NCT ID: NCT02843984
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-03-31
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A - untreated
The patients will be not treated with vaginal lactoferrin
No interventions assigned to this group
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.
Lactoferrin
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.
Lactoferrin
Interventions
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Lactoferrin
Eligibility Criteria
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Inclusion Criteria
* maternal age as the only indication to foetal karyotyping
Exclusion Criteria
* previous miscarriages;
* pregnancy at risk for maternal or foetal disease;
* lactose intolerance.
25 Years
45 Years
FEMALE
No
Sponsors
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Università degli Studi di Ferrara
OTHER
Responsible Party
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Alessandro Trentini
PhD
Locations
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Obstetric Unit, University of Ferrara
Cona, Ferrara, Italy
Countries
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Other Identifiers
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PRUa1GR-2013-00000220-B
Identifier Type: -
Identifier Source: org_study_id
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