Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications
|ClinicalTrials.gov Identifier: NCT02843984|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Drug: Lactoferrin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843984
|Obstetric Unit, University of Ferrara|
|Cona, Ferrara, Italy, 44124|