Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators

Phase 2

Completed

• Conditions: Pregnancy
• Interventions: Drug: Lactoferrin

• Registration Number: NCT02695563
• Lead Sponsor: Università degli Studi di Ferrara

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-02-29
• Status Verified: 2016-03
• Study First Posted: 2016-03-01
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 111

Inclusion Criteria

• singleton gestation
• maternal age as indication to fetal karyotyping

Exclusion Criteria

• consumption of drugs interfering with the immune system
• previous miscarriages
• pregnancy at risk for maternal or fetal disease
• lactose intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin	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
Measurement of inflammatory markers in the amniotic fluid	1 month after the enrollment of patients will be concluded.	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.

Trial Locations

Locations (1)

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