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Lactoferrin or Progesterone for Prevention of Preterm Delivery

NCT02372942 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2018-05-08

No results posted yet for this study

Summary

Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction of the 30% of preterm deliveries versus the use of progesterone, in specific selected patients, with consequent improvement in neonatal outcome.

Secondary endpoint will be compare antibacterial and anti-inflammatory activity of lactoferrin by evaluation of systemic biochemical and urinary markers.

Conditions

  • Preterm Delivery

Interventions

DRUG

Progesterone

515 pregnant women using lattofferrin to preventf preterm delivery lattoferrin or progesterone

DRUG

Lattoferrin

515 pregnant women using lattoferrin to prevent preterm delivery

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Erich Cosmi, MD, PhD · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-11-30
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372942 on ClinicalTrials.gov