Evaluation of isosorbide mononitrate for cervical ripening prior to induction of labor at term pregnancy in an outpatient setting
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20160586Keywords:
Cervical ripening, Induction of labour, Isosorbide mononitrate, Outpatient setting, Term pregnancyAbstract
Background: The objectives of the study were to Evaluation of isosorbide mononitrate for cervical ripening prior to induction of labor at term pregnancy in an outpatient.
Methods: A randomized, placebo controlled prospective study was conducted with 120 women with term pregnancies and unfavorable cervices who self-administered vaginally either 2, 40-mg tablets of IMN or pyridoxine as placebo prior to admission for induction of labor. The main outcome variables were change in Bishop Score, time from admission to delivery, and presence or absence of fetal and maternal morbidity.
Results: The Bishop score was significantly improved 24 hours after initiation of the outpatient IMN treatment. In study group change in Bishops score was 4.83±1.88 and in control group was 1.07±1.27. The needs for further cervical ripening and oxytocin infusion were less in the study than in the control group (P=0.001). The time from admission to delivery was also less (P ≤0.001). Moreover, the IMN treatment had no major adverse maternal or fetal effects. The vast majority of women in both groups were either satisfied or very satisfied with the outpatient treatment.
Conclusions: IMN self-administered at home is safe and effective for cervical ripening prior to induction of labor in women with term pregnancies. It is the very effective method for cervical ripening in outpatient setup.References
Abdellah MS, Hussein M, Aboalhassan A. Intravaginal administration of isosorbide mononitrate and misoprostol for cervical ripening and induction of labor: A randomized controlled trial. Arch Gynecol Obstet. 2011;284:25-30.
Watson WJ, Stevens D, Welter S, Day D. Factors predicting successful labour induction. Obstet Gynecol. 1996;88:990-2.
Stitely ML, Browning J, Fowler M, Gendron RT, Gherman RB. Outpatient cervical ripening with intravaginal misoprostol. Obstet Gynecol. 2000;96(5Pt 1):684-8.
McKenna DS, Costa SW, Samuels P: Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999;94(1):11-4.
Farmer KC, Schwartz WJ 3rd, Rayburn WF, Turnbull G. A cost minimization analysis of intracervical prostaglandin E2 for cervical ripening in an outpatient versus inpatient setting. Clin Ther. 1996;18(4):747-56.
Rayburn W, Tassone S, Pearman C: Is cervidil appropriate for outpatient cervical ripening. Obstet Gynecol. 2000;95:S63.
Voss DH, Cumminsky KC, Cook VD, Nethers MS, Spinnato JA, Gall SA: Effect of three concentrations of intracervical prostaglandin E2 gel for cervical ripening. J Matern Fetal Med. 1996;5(4):186-93.
Chwalisz K, Garfield RE. Nitric oxide as the final metabolic mediator of cervical ripening. Hum Reprod. 1998;13:245-8.
Ledingham MA, Denison FC, Kelly RW, Young A, Norman JE. Nitric oxide donors stimulate prostaglandin F (2 alpha) and inhibit thromboxane B (2) production in the human cervix during the first trimester of pregnancy. Mol Hum Reprod. 1999;5:973-82.
Väisänen-Tommiska M. Nitric Oxide in Human Uterine Cervix: Role in Cervical Ripening. Academic Dissertation, Department of Obstetrics and Gynecology, Faculty of Medicine, Institute of Clinical Medicine, University of Helsinki. Finland. 2006:19-23.
Ekerhovd E, Bullarbo M, Andersch B, Norström A. Vaginal administration of the nitric oxide donor isosorbide mononitrate for cervical ripening at term: A randomized controlled study. Am J Obstet Gynecol. 2003;189:1692-7.
Ledingham MA, Thomson AJ, Greer IA, Norman JE. Nitric oxide in parturition. BJOG. 2000;7:581-93.
Nicoll AE, Machenzie 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;184:958-64.
Bollapragada SS, MacKenzie F, Norrie JD, Eddama O. Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour--clinical trial with analyses of efficacy and acceptability. The IMOP study. BJOG. 2009;116(9):1185-95.
Osman I, MacKenzie F, Norrie J, Murray HM. 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.
Agarwal K, Batra A, Batra A, Dabral A, Aggarwal A.Evaluation of isosorbide mononitrate for cervical ripening prior to induction of labor for postdated pregnancy in an outpatient setting. Int J Gynaecol Obstet. 2012;118(3):205-9.
Helal AMM, Abd El-Razek M. Randomized double –blind controlled study to determine the effect of vaginally applied nitric oxide donor (isosorbide mononitrate) for preinduction cervical ripening on maternal & fetal hemodynamics and the ripening of the cervix. El-minia med. 2004;15(1).
Bullarbo M, Orrskog ME, Andersch B, Granström L, Norström A, Ekerhovd E. Outpatient vaginal administration of the nitric oxide donor isosorbide mononitrate for cervical ripening and labor induction post term: A randomized controlled study. Am J Obstet Gynecol. 2007;196:e1-5.
Habib SM, Emam SS, Saber AS. Outpatient cervical ripening with nitric oxide donor isosorbide mononitrate prior to induction of labor. Int J Gynaecol Obstet. 2008;101(1):57-61.
Eddama O, Petrou S, Schroeder L, Bollapragada SS, Mackenzie F, Norrie J. The cost-effectiveness of outpatient (at home) cervical ripening with isosorbide mononitrate prior to induction of labour. BJOG. 2009;116(9):1196-203.
Yazdizadeh H, Abedi P, Najar S. The impact of isosorbide mononitrate on cervical ripening and labor induction in primiparous women with term pregnancy: A double-blind, randomized, controlled trial. Iran J Nurs Midwifery Res. 2013;18(3):246-50.
