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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Drug: Lactoferrin

• Registration Number: NCT02843984
• Lead Sponsor: Università degli Studi di Ferrara

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-21
• Last Update Submitted: 2016-07-21
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C - 12 hrs treatment	Lactoferrin	The patients will be administered with a single dose of 300 mg vaginal lactoferrin 12 hours prior to mid-trimester genetic amniocentesis.
B - 4 hrs treatment	Lactoferrin	The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.

Primary Outcome Measures

Name	Time	Method
Amniotic fluid concentration of mediators involved in inflammation	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.

Trial Locations

Locations (1)

Obstetric Unit, University of Ferrara; 🇮🇹 Cona, Ferrara, Italy