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

Sponsor

Università degli Studi di Ferrara (Other)

Overall Status

Completed

CT.gov ID

NCT02695563

Collaborator

(none)

111

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: Lactoferrin	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Influence of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on PGE2, MMP-9, MMP-2, TIMP-1 and TIMP-2 Amniotic Fluid Concentrations

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: controls The patients will be not treated with vaginal lactoferrin
Active Comparator: Lactoferrin The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.	Drug: Lactoferrin

Arm

Intervention/Treatment

No Intervention: controls

The patients will be not treated with vaginal lactoferrin

Active Comparator: Lactoferrin

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

Drug: Lactoferrin

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetric Unit, University of Ferrara	Cona	Ferrara	Italy	44124

Sponsors and Collaborators

Università degli Studi di Ferrara

Investigators

Study Director: Carlo Contini, Professor, Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alessandro Trentini, PhD, Università degli Studi di Ferrara

ClinicalTrials.gov Identifier:

NCT02695563

Other Study ID Numbers:

PRUa1GR-2013-00000220

First Posted:

Mar 1, 2016

Last Update Posted:

Mar 4, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Alessandro Trentini, PhD, Università degli Studi di Ferrara

Amniocentesis

Additional relevant MeSH terms:

Lactoferrin

Study Results

No Results Posted as of Mar 4, 2016