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

March 3, 2016 updated by: Alessandro Trentini, Università degli Studi di Ferrara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Obstetric Unit, University of Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of inflammatory markers in the amniotic fluid
Time Frame: 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.
1 month after the enrollment of patients will be concluded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRUA1GR-2013-00000220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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