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

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

Detailed Description
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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.

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Lactoferrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amniotic fluid concentration of mediators involved in inflammation | 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. | 1 month after the enrollment of patients will be concluded. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniocentesis