Preinduction cervical ripening using oral and vaginal isosorbide dinitrate in patients with term pregnancy : A randomized clinical trial

authors:

avatar Somayeh Moukhah , * , avatar firoozeh ahmadi


how to cite: Moukhah S, ahmadi F. Preinduction cervical ripening using oral and vaginal isosorbide dinitrate in patients with term pregnancy : A randomized clinical trial. koomesh. 2024;17(4):e151178. 

Abstract

Introduction: Cervical ripening in labor is one of the most important objects in midwifery. Isosorbide dinitrate (ISDN) is one of the most important agents, which has been proposed for cervical ripening, but there are still controversies regarding its prescription. The present study aimed to assess the effects of vaginal and oral ISDN for preinduction cervical ripening. Materials and Methods: In this non-blinded clinical trial, 99 nulliparous women with term or prolonged pregnancy were selected and were randomly divided into two groups by block randomization. The intervention groups included those received vaginal ISDN (n=50, 40 mg, daily) and oral ISDN (n=49, 20 mg, twice daily). Size of ripening was measured by bishop score before treatment and 24 hours after that. Results: 24 hours after treatment, bishop score was significantly increased (P < 0.001)in both the vaginal and oral ISDN groups. Both groups were compared regarding the pregnancy termination and cesarean causes, and no significant difference was found between them (P > 0.05).  Duration of induction to the second phase of delivery was compared in two groups.  Although there was not any significant difference between the two groups in terms of shifting time from the active phase to delivery and duration of the second phase (P > 0.05), there was a meaningful difference between two groups in duration from induction to the active phase of delivery (P < 0.001). Also shifting time from induction to the active phase of delivery in vaginal ISDN group was shorter than oral ISDN group (3.7 hour versus 4.8 hour). Conclusion: Prescribing vaginal ISDN for cervical ripening was more effective than oral medication, and it seems to be with minimum side effects.

References

  • 1.

    Cunningham FG, Gant NF, Leveno KJ. Williams Obstetrics. 23nd ed. New York: McGraw-Hill 2010; chapters 37, 9, 22.

  • 2.

    Neale E, Pachulski A, Whiterod S, McGuinness E, Gallagher N, Wallace R. Outpatient cervical ripening prior to induction of labour. J obstet Gynecol 2002; 22: 634-635.

  • 3.

    Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician 2003; 15: 2123-2128.

  • 4.

    Maul H, Mackay L, Garfield RE. Cervical ripening: biochemical, molecular, and clinical considerations. Clin Obstet Gynecol 2006; 49: 551-563.

  • 5.

    Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings (Review). Cochrane Database Sys Rev 2010; 8. http://www.thecochranelibrary.com.

  • 6.

    Mozurkewich EL, Chilimigras JL, Berman DR, Perni UC, Romero VC, King VJ, Keeton KL. Methods of induction of labour: a systematic Review. BMC Pregnancy Childbirth 2011; 11: 1-19.

  • 7.

    Bishop EH. Pelvic scoring for elective induction. Obstet Gynecol 1964; 24: 266-268.

  • 8.

    Wing DA, Gaffaney CA. Vaginal misoprostol administration for cervical ripening and labor induction. Clin Obstet Gynecol 2006; 49: 627-641.

  • 9.

    Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol 2006; 49: 642-657.

  • 10.

    Shepherd JH, Knuppel RA. The role of prostaglandins in ripening the cervix and inducing labor. Clin Perinatol 1981; 8: 49-62.

  • 11.

    Wing DA. Labor induction with misoprostol. Am J Obstet Gynecol 1999; 181: 339-345.

  • 12.

    Herabutya Y, O-Prasertsawat P, Pokpirom J. A comparison of intravaginal misoprostol and intracervical prostaglandin E2 gel for ripening of unfavorable cervix and labor induction. J Obstet Gynaecol Res 1997; 23: 269-274.

  • 13.

    Nicoll AE, MacKenzie F, Greer IA, Norman JE. Vaginal application of the nitric oxide donor isosorbide mononitrate for preinduction cervical ripening: a randomized controlled trial to determine effects on maternal and fetal hemodynamics. Am J Obstet Gynecol 2001; 184: 958-964.

  • 14.

    Kelly AJ, Tan B. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database of Syst Rev 2001; 3: CD003246.

  • 15.

    Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev 2003; 4: CD003101.

  • 16.

    Bollagragada S, Mackenzie F. A randomized placebo controlled trial of outpatient cervical ripening with isosorbidemononitrate prior to induction of labour. BMC Pregnancy Childbirth 2006; 6: 25.

  • 17.

    Ekerhovd E, Bullarbo M, Anderson B. Vaginal administration of nitric oxide donor isosorbide mononitrate for cervical ripening at term: A randomized controlled study. Am J Obstet Gynecol 2003; 189: 1692-1697.

  • 18.

    Buhimuschi I, Ali M, Jan V. Differential regulation of nitric oxide in the rat uterus and cervix during pregnancy and labour. Hum Reprod 1996; 11: 1755-1766.

  • 19.

    Visnen-Tommiska MR. Nitric oxide in the human uterine cervix: endogenous ripening factor. Ann Med 2008; 40: 45-55.

  • 20.

    Chwalisz K, Shi SQ, Garfield RE, Beir HM. Cervical ripening in guineapigs after a local application of nitric oxide. Hum Reprod 1997; 12: 2093-2101.

  • 21.

    Buhimschi I, Ali M, Jain V, Chwalisz K, Garfield RE. Differential regulation of nitric oxide in the rat uterus and cervix during pregnancy and labor. Hum Reprod 1996; 11: 1755-1766.

  • 22.

    Facchinetti F, Piccinibi F, Volpe A. Chemical ripening of the cervix with intracervical application of sodium nitroprusside: a randomized controlled trial. Hum Reprod 2000; 15: 2224-2227.

  • 23.

    Monica M, Wolfer, Fabio Facchinetti. Induction of labor at term using isosorbide mononitrate simultaneously with dinoproston compared to dinoprostone alone: A randomized controlled trial. Am J Obstet Gynecol 2006; 195: 1617-1622.

  • 24.

    Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol 2010; 116: 121-126.

  • 25.

    Haghighi L, Homam H, Raoofi Z, Najmi Z. Intravaginal isosorbide dinitrate or misoprostol for cervical ripening prior to induction of labour: A randomised controlled trial. J Obstet Gynaecol 2013; 33: 272-276.

  • 26.

    Arteaga-Troncoso G, Villegas-Alvarado A, Belmont-Gomez A, Martinez-Herrera FG, Villagrana-Zesati R, Guerra-Infantea F. Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomized controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception. BJOG 2005; 112: 1615-1619.

  • 27.

    Hidar S, Bouddebous M, Chaeb A, Jerbi M, Bibi M, Khari H. Randomized controlled trial of vaginal misoprostol versus vaginal misoprostol and isosorbide dinitrate for termination of pregnancy at 1329 weeks. Arch Gynecol Obstet 2005; 273: 157-160.

  • 28.

    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: 1012-1021.

  • 29.

    Chanrachakul B, Herabutya Y, Punyavachira P. Randomized trial of isosorbide mononitrate versus misoprostol for cervical ripening at term. Int J Gynaecol Obstet 2002; 78: 139-145.

  • 30.

    Wlfler MM, Facchinetti F, Venturini P, Huber A, Helmer H, Husslein P, Tschugguel W. Induction of labor at term using isosorbide mononitrate simultaneously with dinoproston compared to dinoprostone alone: A randomized controlled trial. Am J Obstet Gynecol 2006; 195: 1617-1622.

  • 31.

    Bates CD, Nicoll AE, Mullen AB. Serum profile of isosorbide mononitrate after vaginal administration in the third trimester. BJOG 2003; 110: 64-67.##[32 Chanrachakul B, Herabutya Y, Punyavachira P. Randomized trial of isosorbide mononitrate versus misoproston for cervical ripening at term. Int J Gynecol Obstet 2002; 78: 139-145.

  • 32.

    Chanrachakul B, Herabutya Y, Punyavachira P. Randomized comparison of glyceryl trinitrate and prostaglandin E2 for cervical ripening at term. Obstet Gynecol 2000; 96: 549-553.

  • 33.

    Duhan N, Gupta S, Dahiya K, Sirohiwal D, Rohilla S. Comparison of isosorbide mononitrate and misoprostol for cervical ripening in termination of pregnancy between 8 and 12 weeks: a randomized controlled trial. Arch Gynecol Obstet 2010; 13.

  • 34.

    Chanrachakul B, Herabutya Y, Punyavachira P. Randomized trial of isosorbide mononitrate versus misoprostol for cervical ripening at term. Int J Gynaecol Obstet 2002; 78: 139-145.

  • 35.

    Abdellah MS, Hussien M, Aboalhassan A. Intravaginal administration of isosorbide mononitrate and misoprostol for cervical ripening and induction of labour: a randomized controlled trial. Arch Gynecol Obstet 2011; 284: 25-30.

  • 36.

    Romero-Gutirrez G, Bernal Gonzlez OE, Ponce-Ponce de Len AL. Comparison of isosorbide dinitrate and dinoprostone for induction of labor in term pregnancy. Ginecol Obstet Mex 2011; 79: 285-291.##.