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Lactoferrin or Progesterone for Prevention of Preterm Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372942
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Erich Cosmi MD, PhD, University of Padova

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.


Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: Lattoferrin Drug: Progesterone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1030 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Lactoferrin or Progesterone for Prevention of Preterm Delivery
Actual Study Start Date : February 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lattoferrin
Use of Lattoferin for prevention of preterm delivery
Drug: Lattoferrin
515 pregnant women using lattoferrin to prevent preterm delivery
Other Name: Difesan

Experimental: Progesterone
Use of Progesterone for prevention of preterm delivery
Drug: Progesterone
515 pregnant women using lattofferrin to preventf preterm delivery lattoferrin or progesterone
Other Name: Progeffik




Primary Outcome Measures :
  1. delayed days of birth using lattoferrin or progesterone [ Time Frame: days or weeks ]

Secondary Outcome Measures :
  1. neonatal outcome [ Time Frame: 28 days and 2 years follou-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372942


Locations
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Italy
University of Padua
Padua, Italy, 35128
Sponsors and Collaborators
University of Padova
Investigators
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Principal Investigator: Erich Cosmi, MD, PhD University of Padova
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Responsible Party: Erich Cosmi MD, PhD, Associate Professor in Obstetrica and Gynecolgy, University of Padova
ClinicalTrials.gov Identifier: NCT02372942    
Other Study ID Numbers: University of Padua
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Erich Cosmi MD, PhD, University of Padova:
efficacy
prevention
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs