A comparative study to determine the effectiveness of oral mifepristone and vaginal isosorbide mononitrate as cervical ripening agents for induction of labor in pregnant women with gestational  age 28 to 34 weeks

Meeta Pandit; Anupama Dave; Akanksha Thora; Aparna Dwivedi

doi:10.18203/2320-1770.ijrcog20251981

Authors

Meeta Pandit Department of Obstetrics and Gynaecology, MGM Medical College and M.T.H. Hospital, Indore, Madhya Pradesh, India
Anupama Dave Department of Obstetrics and Gynaecology, MGM Medical College and M.T.H. Hospital, Indore, Madhya Pradesh, India
Akanksha Thora Department of Obstetrics and Gynaecology, MGM Medical College and M.T.H. Hospital, Indore, Madhya Pradesh, India
Aparna Dwivedi Department of Obstetrics and Gynaecology, MGM Medical College and M.T.H. Hospital, Indore, Madhya Pradesh, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20251981

Keywords:

Cervical ripening, Oral mifepristone, Vaginal isosorbide mononitrate IMN, Induction of labor IOL

Abstract

Background: The process of inducing labor is definitely one of the most commonly done obstetric procedures worldwide. An unfavourable cervix is a major reason for unsuccessful induction. Cervix must be softened. IOL should only be performed when there is an obvious medical need and advantages are greater than risks.

Methods: The present study was conducted at the Department of Obstetrics and Gynaecology, MGM Medical College, Indore from February 2023 to January 2024.One hundred pregnant women of gestational age 28 to 34 weeks, who had a valid indication for termination of pregnancy, were included in the study after valid consent and randomised into two groups. Oral Mifepristone was used in one group and vaginal isosorbide mononitrate IMN in the other. Modified Bishops Score was subsequently assessed and compared.

Results: In the study, indications for termination were hypertensive disorders of pregnancy, IUFD, anhydramnios, severe oligohydramnios and PPROM. Mean±SD of Bishop score before and after IMN were 1.84±1.23 and 4.40±1.34, whereas for Mifepristone 1.42±1.42 and 4.92±1.68, respectively. Mean cervical ripening to delivery time in IMN group was 30.04±3.37 hours; while in mifepristone group, it was 28.50±3.48 hours. Most patients delivered vaginally in both the groups (IMN group 88%; mifepristone group 94%). Both Mifepristone and IMN were generally well-tolerated by participants.

Conclusions: This study provides evidence supporting the effectiveness of both drugs as cervical ripening agents.

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References

Marconi AM. Recent advances in the induction of labor. F1000Res 2019;8:1829. DOI: https://doi.org/10.12688/f1000research.17587.1

Abrar S, Abrar T, Sayyed E, Naqvi SA. Ruptured uterus: Frequency, risk factors and feto-maternal outcome: Current scenario in a low-resource setup. PLoS One 2022;17(4):e0266062. DOI: https://doi.org/10.1371/journal.pone.0266062

Carlson N, Ellis J, Page K, Dunn Amore A, Phillippi J. Review of evidence-based methods for successful labor induction. J Midwifery Womens Health 2021;66(4):459–69. DOI: https://doi.org/10.1111/jmwh.13238

Arteaga-Troncoso G, Villegas-Alvarado A, Belmont-Gomez A, Martinez-Herrera FJ, Villagrana-Zesati R, Guerra-Infante F. Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception. BJOG 2005;112(12):1615–9. DOI: https://doi.org/10.1111/j.1471-0528.2005.00760.x

Priyanka SS. The effect of mifepristone in induction of labour at term Medpulse. International Journal of Gynaecology February 2021;17:32–5. DOI: https://doi.org/10.26611/10121726

Dixit MS, Somalwar SA, Tathe GR. Effectiveness of Isosorbide Mononitrate vs Prostaglandin E2 Gel for Cervical Ripening: A Study. J South Asian Feder Obst Gynae 2019;11(5):288–91. DOI: https://doi.org/10.5005/jp-journals-10006-1712

Dave A, Nigam P, Maru L. Isosorbide mononitrate a nitric oxide donor: A study of its efficacy and safety as an agent for cervical ripening. J Obstet Gynaecol India 2015;65(3):162–6. DOI: https://doi.org/10.1007/s13224-014-0577-5

Osman I, MacKenzie F, Norrie J, Murray HM, Greer IA, Norman JE. The “PRIM” study: a randomized comparison of prostaglandin E2 gel with the nitric oxide donor isosorbide mononitrate for cervical ripening before the induction of labor at term. Am J Obstet Gynecol 2006;194(4):1012–21. DOI: https://doi.org/10.1016/j.ajog.2005.10.812

Li L, Gao W, Chen S. Labour induction in women at term with mifepristone and misoprostol. Zhonghua Fu Chan Ke Za Zhi 1996;31(11):681–4.

Byrne JD, Wing DA, Fraser M, Fassett MJ, Goodwin TM, Challis JRG. Mifepristone: effect on plasma corticotropin-releasing hormone, adrenocorticotropic hormone, and cortisol in term pregnancy. J Perinatol 2004;24(7):416–20. DOI: https://doi.org/10.1038/sj.jp.7211127

Fathima S, Nayak SR, Rao B, Gandhi P, Shameem V. Mifepristone in induction of labour at term. International Journal of Pharmaceutical and Biomedical Research 2013;4(3):164–6.

Agarwal K, Batra A, Batra A, Aggarwal A. Randomized comparison of isosorbide mononitrate and PGE2 gel for cervical ripening at term including high risk pregnancy. Int J Reprod Med 2014;2014:1–5. DOI: https://doi.org/10.1155/2014/147274

Dharani H, James PN. Mifepristone for induction of labour (review). Chochrane Database Syst Rev 2009;3:1.