NCT02843984

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 19, 2016

Last Update Submit

July 21, 2016

Conditions

Pregnancy

Keywords

Amniocentesis

Outcome Measures

Primary Outcomes (1)

  • Amniotic fluid concentration of mediators involved in inflammation

    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.

    1 month after the enrollment of patients will be concluded.

Study Arms (3)

A - untreated

NO INTERVENTION

The patients will be not treated with vaginal lactoferrin

B - 4 hrs treatment

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

C - 12 hrs treatment

ACTIVE COMPARATOR

The patients will be administered with a single dose of 300 mg vaginal lactoferrin 12 hours prior to mid-trimester genetic amniocentesis.

Drug: Lactoferrin

Interventions

LactoferrinDRUG
B - 4 hrs treatmentC - 12 hrs treatment

Eligibility Criteria

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

You may qualify if:

  • singleton physiological pregnancy;
  • maternal age as the only indication to foetal karyotyping

You may not qualify if:

  • assumption of drugs interfering with the immune system;
  • previous miscarriages;
  • pregnancy at risk for maternal or foetal 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

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 26, 2016

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 26, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)