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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controls | No Intervention | The patients will be not treated with vaginal lactoferrin | |
| Lactoferrin | Active Comparator | The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of inflammatory markers in the amniotic fluid | 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. | 1 month after the enrollment of patients will be concluded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Contini, Professor | Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetric Unit, University of Ferrara | Cona | Ferrara | 44124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33015104 | Derived | Trentini A, Maritati M, Rosta V, Cervellati C, Manfrinato MC, Hanau S, Greco P, Bonaccorsi G, Bellini T, Contini C. Vaginal Lactoferrin Administration Decreases Oxidative Stress in the Amniotic Fluid of Pregnant Women: An Open-Label Randomized Pilot Study. Front Med (Lausanne). 2020 Sep 8;7:555. doi: 10.3389/fmed.2020.00555. eCollection 2020. | |
| 27872513 |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Trentini A, Maritati M, Cervellati C, Manfrinato MC, Gonelli A, Volta CA, Vesce F, Greco P, Dallocchio F, Bellini T, Contini C. Vaginal Lactoferrin Modulates PGE2, MMP-9, MMP-2, and TIMP-1 Amniotic Fluid Concentrations. Mediators Inflamm. 2016;2016:3648719. doi: 10.1155/2016/3648719. Epub 2016 Oct 31. |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |