Lactoferrin or Progesterone for Prevention of Preterm Delivery

NCT02372942 | Unknown Phase 4 DMC

• 1 other identifier: University of Padua
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

efficacy; prevention

Outcome Measures

Primary Outcomes (1)

• delayed days of birth using lattoferrin or progesterone

  days or weeks

Secondary Outcomes (1)

• neonatal outcome

  28 days and 2 years follou-up

Study Arms (2)

Lattoferrin

EXPERIMENTAL

Use of Lattoferin for prevention of preterm delivery

Drug: Lattoferrin

Progesterone

EXPERIMENTAL

Use of Progesterone for prevention of preterm delivery

Drug: Progesterone

Interventions

Lattoferrin DRUG

515 pregnant women using lattoferrin to prevent preterm delivery

Also known as: Difesan

Lattoferrin

Progesterone DRUG

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

Also known as: Progeffik

Progesterone

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cervical length less than 25 mm between 24 and 34 weeks' gestation (with or without funnelling)
• cervical effacement less than 50 percent and cervical dilatation less than 3 cm
• uterine contractions less than 4 in 30 minutes
• singleton pregnancy
• absence of chorioamnionitis signs (white cells count\< 15.000, Reactive Protein C\< 10 mg/l, Procalcitonin levels \< 0,05 ng/ml),
• absence of premature membrane rupture (pPROM).

You may not qualify if:

• Fetal abnormalities such as severe intrauterine growth restriction and fetal malformations with progressive deterioration
• Maternal diseases such as gestation diabetes insulin-treated, severe nephropaties, severe cardiopathies, autoimmune diseases
• Twin pregnancy
• Signs of maternal infections (chorioamnionitis)
• Premature rupture of membrane

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padua

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Erich Cosmi, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Obstetrica and Gynecolgy

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2020
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)