NCT02695563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2 pregnancy

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

February 24, 2016

Last Update Submit

March 3, 2016

Conditions

Pregnancy

Keywords

Amniocentesis

Outcome Measures

Primary Outcomes (1)

  • Measurement of inflammatory markers in the amniotic fluid

    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.

Study Arms (2)

controls

NO INTERVENTION

The patients will be not treated with vaginal lactoferrin

Lactoferrin

ACTIVE COMPARATOR

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

Drug: Lactoferrin

Interventions

LactoferrinDRUG
Lactoferrin

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton gestation
  • maternal age as indication to fetal karyotyping

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetric Unit, University of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (2)

  • Trentini A, Maritati M, Rosta V, Cervellati C, Manfrinato MC, Hanau S, Greco P, Bonaccorsi G, Bellini T, Contini C. Vaginal Lactoferrin Administration Decreases Oxidative Stress in the Amniotic Fluid of Pregnant Women: An Open-Label Randomized Pilot Study. Front Med (Lausanne). 2020 Sep 8;7:555. doi: 10.3389/fmed.2020.00555. eCollection 2020.

    PMID: 33015104DERIVED

  • Trentini A, Maritati M, Cervellati C, Manfrinato MC, Gonelli A, Volta CA, Vesce F, Greco P, Dallocchio F, Bellini T, Contini C. Vaginal Lactoferrin Modulates PGE2, MMP-9, MMP-2, and TIMP-1 Amniotic Fluid Concentrations. Mediators Inflamm. 2016;2016:3648719. doi: 10.1155/2016/3648719. Epub 2016 Oct 31.

    PMID: 27872513DERIVED

MeSH Terms

Interventions

Lactoferrin

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteins

Study Officials

  • Carlo Contini, Professor

    Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 1, 2016

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

March 4, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)