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

IF 0.1 Q4 OBSTETRICS & GYNECOLOGY Clinica e Investigacion en Ginecologia y Obstetricia Pub Date : 2023-10-01 DOI:10.1016/j.gine.2023.100883

C. Murillo , F. Migliorelli , C. Nieto , H. Martínez , C. Rueda , R. Bermejo , A. Corrales , M. Palacio

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Abstract

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.

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一项评估硝苯地平口服溶液治疗早产安全性的多中心、开放标签、前瞻性观察性研究

目的分析硝苯地平口服液治疗早产（PTL）的安全性。在常规临床实践中口服硝苯地平溶液的安全性和耐受性被评估为本研究的主要目标，治疗效果被评估为次要目标。结果在这些妇女中没有报告严重的不良事件，包括严重低血压。8名患者（2.3%）报告了中等强度的不良反应，0.9%的患者（3例）因这些不良反应而停止治疗。结论本研究结果表明，硝苯地平口服液用于PTL妇女的保胎治疗具有良好的安全性。

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来源期刊

Clinica e Investigacion en Ginecologia y Obstetricia OBSTETRICS & GYNECOLOGY-

CiteScore

0.20

自引率

0.00%

发文量

期刊介绍： Una excelente publicación para mantenerse al día en los temas de máximo interés de la ginecología de vanguardia. Resulta idónea tanto para el especialista en ginecología, como en obstetricia o en pediatría, y está presente en los más prestigiosos índices de referencia en medicina.