A multi-centre, open-label, prospective, observational study to assess the safety of a nifedipine oral solution in the treatment of preterm labor

Objective: To analyze the safety profile of a nifedipine oral solution in the treatment of preterm labor (PTL). Methods: A multi-center, open-label, prospective, single-arm, observational study was conducted in 500 women with PTL to whom a nifedipine oral solution was prescribed according to its Summary of Product Characteristics. Safety profile and tolerability of oral administration of nifedipine solution during routine clinical practice was assessed as the primary objective of the study and treatment efficacy as secondary objective. Results: No severe adverse events were reported among these women, including severe hypotension. Eight patients (2.3%) reported adverse reactions of moderate intensity, and in 0.9% of the patients (3 cases), these adverse reactions caused the discontinuation of the treatment. Conclusions: The results of this study show that nifedipine oral solution exhibits an excellent safety profile used as a tocolytic treatment in women with PTL. (c) 2023 The Authors. Published by Elsevier Espana, S.L.U. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).