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OpenTrials
Completed

NCT Number: NCT02843984

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

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

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Key information

Conditions

Pregnancy

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetric Unit, University of Ferrara

Cona, Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactoferrin

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2016
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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