drugset / Trial / NCT02695563
Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2014-01
- Primary completion
- 2015-03
- Completion
- 2015-09
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lactoferrin | Protein / enzyme biologic | 300 mg | Other |