Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries
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13.08.2019 |
Villani M.
Baldini D.
Totaro P.
Larciprete G.
Kovac M.
Carone D.
Passamonti S.
Permunian E.
Bartolotti T.
Lojacono A.
Cacciola R.
Pinto G.
Bucherini E.
De Stefano V.
Lodigiani C.
Lavopa C.
Cho Y.
Pizzicaroli C.
Colaizzo D.
Grandone E.
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BMC Pregnancy and Childbirth |
10.1186/s12884-019-2444-y |
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© 2019 The Author(s). Background: Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50-60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries. Methods: OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. Discussion: Although RCTs are the 'gold standard' for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions. Trial registration: NCT 02385461, retrospectively registered 5 March 2015 (OTTILIA); NCT 02685800, registered 10 February 2016 (FIRST).
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Preparation of Low-Molecular-Weight Heparins by Radiation-Induced Destruction
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01.05.2018 |
Tuaeva N.
Trukhan V.
Kardonskii D.
Eganov A.
Grebenkina E.
Veselov V.
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Pharmaceutical Chemistry Journal |
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0 |
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© 2018, Springer Science+Business Media, LLC, part of Springer Nature. Low-molecular-weight heparins (LMWHs) are widely used in medical practice. LMWHs are produced using various methods of controlled depolymerization of unfractionated heparin (UFH). Herein, a method for radiation-induced destruction of aqueous heparin solutions using a 60Co gamma-irradiation source is presented. The optimal conditions for depolymerization of starting heparin were found. The anticoagulant activity of LMWHs was studied as a function of irradiation dose. The results allowed this LMWH production method to be recommended for development of new anticoagulants.
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