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Evaluation of nitric acid donor, transdermal glycerol trinitrate patches for facilitating cervical ripening: a randomised controlled trial

  • Maternal-Fetal Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

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.

Methods

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.

Results and discussion

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.

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Data availability

Data supporting this study are included within the article and/or supporting materials.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, College of Medicine and Sagar Dutta Hospital, 578, Barrackpore Trunk Road, Kolkata, West Bengal, 700058, India

    Sanjoy Kumar Bhattacharyya, Prithwikar Mandal, Sanjib Dutta, Subhadeep Basak, Rumina Bagchi & Alapan Halder

Authors
  1. Sanjoy Kumar Bhattacharyya
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  2. Prithwikar Mandal
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  3. Sanjib Dutta
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  6. Alapan Halder
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Contributions

SKB: concept and design and protocol development of the study, data retrieval, data analysis and manuscript drafting and writing. PM: participated in the study, data retrieval, data analysis and manuscript drafting. SB: participated in the study, data retrieval, data analysis and manuscript drafting. SD and AH: statistical analysis and helped to edit the manuscript. RB: participated in the study in later part and also played a role while drafting the manuscript.

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Correspondence to Sanjoy Kumar Bhattacharyya.

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Bhattacharyya, S.K., Mandal, P., Dutta, S. et al. Evaluation of nitric acid donor, transdermal glycerol trinitrate patches for facilitating cervical ripening: a randomised controlled trial. Arch Gynecol Obstet (2023). https://doi.org/10.1007/s00404-023-07180-9

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  • DOI: https://doi.org/10.1007/s00404-023-07180-9

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