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

Università degli Studi di Ferrara

Status: Completed

Conditions: Pregnancy

Treatments: Drug: Lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02843984

PRUa1GR-2013-00000220-B

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

A - untreated

No Intervention group

Description:

The patients will be not treated with vaginal lactoferrin

B - 4 hrs treatment

Active Comparator group

Description:

The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.

Treatment:

Drug: Lactoferrin

C - 12 hrs treatment

Active Comparator group

Description:

The patients will be administered with a single dose of 300 mg vaginal lactoferrin 12 hours prior to mid-trimester genetic amniocentesis.

Treatment:

Drug: Lactoferrin