Department of Obstetrics and Gynaecology, College of Medicine and Sagar Dutta Hospital, 578, Barrackpore Trunk Road, Kolkata, West Bengal, 700058, India.
Arch Gynecol Obstet. 2024 Jun;309(6):2653-2661. doi: 10.1007/s00404-023-07180-9. Epub 2023 Aug 31.
To evaluate the efficacy and safety of transdermal glycerol trinitrate skin patches as an additive and effective agent for facilitating cervical ripening for labour induction.
This was a double-blinded prospective randomised clinical trial carried out in a major obstetric unit in India. Women who planned for labour induction were randomly allocated for induction either by combined application of glycerol trinitrate skin patches [GTN patch] and intracervical dinoprostone gel or by the gel only. Sample randomisation was done using a stratified block randomisation technique with a sealed envelope. The numbers designating the group allocation sequence were concealed from doctors, research staff, and investigators. Six hourly improvements were assessed in the modified Bishop's score, induction-delivery time interval, the need for oxytocin, maternal side effects and foetal outcomes. Data were analysed using SPSS software.
Recruitment Bishop scores, parity and gestational age were matched in both cases and the control group. The modified Bishop's score was statistically improved in study groups, as evidenced compositely and irrespective of parity. The two groups appeared to have no significant differences regarding other outcomes. The additional application of the GTN patch seems helpful to accelerate the progress of labour but could not yield any favourable labour outcome. The GTN patch does not impose additional feto-maternal adverse effects apart from increased incidences of headaches.
评估硝酸甘油透皮贴片作为一种辅助和有效的促宫颈成熟药物，用于引产的疗效和安全性。
这是在印度一家主要产科单位进行的一项双盲前瞻性随机临床试验。计划引产的妇女随机分为联合应用硝酸甘油贴片（GTN 贴片）和宫颈内前列腺素凝胶或仅应用凝胶组进行引产。采用密封信封的分层区组随机化技术进行样本随机化。指定分组序列的数字对医生、研究人员和调查人员保密。每 6 小时评估改良的 Bishop 评分、引产-分娩时间间隔、催产素的需求、母体副作用和胎儿结局的改善情况。使用 SPSS 软件进行数据分析。
病例组和对照组的募集 Bishop 评分、产次和胎龄相匹配。改良的 Bishop 评分在研究组中均有统计学改善，无论产次如何，均有综合改善。两组在其他结局方面似乎没有显著差异。额外应用 GTN 贴片似乎有助于加速产程，但不能产生任何有利的分娩结局。除头痛发生率增加外，GTN 贴片不会对胎儿-母体产生额外的不良影响。
