Medical Management of Late Intrauterine Death.

Summary

The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide dinitrate-oxytocin in combination in the management of late intrauterine foetal death.

Timeline

Start

2008-05

Primary completion

2013-09

Completion

2014-05

Publications

• Background World Health Organization. Induction and augmentation of labour. In: WHO, UNFPA, UNICEF, World Bank, editor. Managing Complications in Pregnancy and Childbirth: A Guide for Midwives and Doctors. Geneva: WHO; 2000. pp. 17-25.
• Results Koopmans L, Wilson T, Cacciatore J, Flenady V. Support for mothers, fathers and families after perinatal death. Cochrane Database Syst Rev. 2013 Jun 19;2013(6):CD000452. doi: 10.1002/14651858.CD000452.pub3.
• Results Radestad I, Steineck G, Nordin C, Sjogren B. Psychological complications after stillbirth--influence of memories and immediate management: population based study. BMJ. 1996 Jun 15;312(7045):1505-8. doi: 10.1136/bmj.312.7045.1505.
• Results Silver RM, Heuser CC. Stillbirth workup and delivery management. Clin Obstet Gynecol. 2010 Sep;53(3):681-90. doi: 10.1097/GRF.0b013e3181eb3297.
• Results Hughes EG, Kelly AJ, Kavanagh J. Dinoprostone vaginal insert for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 2001 May;97(5 Pt 2):847-55. doi: 10.1016/s0029-7844(00)01216-3.
• Results Neiger R, Greaves PC. Comparison between vaginal misoprostol and cervical dinoprostone for cervical ripening and labor induction. Tenn Med. 2001 Jan;94(1):25-7.
• Results Bolnick JM, Velazquez MD, Gonzalez JL, Rappaport VJ, McIlwain-Dunivan G, Rayburn WF. Randomized trial between two active labor management protocols in the presence of an unfavorable cervix. Am J Obstet Gynecol. 2004 Jan;190(1):124-8. doi: 10.1016/s0002-9378(03)00952-9.
• Results Khan RU, El-Refaey H, Sharma S, Sooranna D, Stafford M. Oral, rectal, and vaginal pharmacokinetics of misoprostol. Obstet Gynecol. 2004 May;103(5 Pt 1):866-70. doi: 10.1097/01.AOG.0000124783.38974.53.
• Results 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 Dec;112(12):1615-9. doi: 10.1111/j.1471-0528.2005.00760.x.
• Results Ignarro LJ, Lippton H, Edwards JC, Baricos WH, Hyman AL, Kadowitz PJ, Gruetter CA. Mechanism of vascular smooth muscle relaxation by organic nitrates, nitrites, nitroprusside and nitric oxide: evidence for the involvement of S-nitrosothiols as active intermediates. J Pharmacol Exp Ther. 1981 Sep;218(3):739-49. No abstract available.
• Results Ignarro LJ. Heme-dependent activation of soluble guanylate cyclase by nitric oxide: regulation of enzyme activity by porphyrins and metalloporphyrins. Semin Hematol. 1989 Jan;26(1):63-76. No abstract available.
• Results Schmidt HH, Lohmann SM, Walter U. The nitric oxide and cGMP signal transduction system: regulation and mechanism of action. Biochim Biophys Acta. 1993 Aug 18;1178(2):153-75. doi: 10.1016/0167-4889(93)90006-b. No abstract available.
• Results Murad F. Regulation of cytosolic guanylyl cyclase by nitric oxide: the NO-cyclic GMP signal transduction system. Adv Pharmacol. 1994;26:19-33. doi: 10.1016/s1054-3589(08)60049-6.
• Results Chung SJ, Fung HL. Identification of the subcellular site for nitroglycerin metabolism to nitric oxide in bovine coronary smooth muscle cells. J Pharmacol Exp Ther. 1990 May;253(2):614-9.
• Results Feelisch M, Kelm M. Biotransformation of organic nitrates to nitric oxide by vascular smooth muscle and endothelial cells. Biochem Biophys Res Commun. 1991 Oct 15;180(1):286-93. doi: 10.1016/s0006-291x(05)81290-2.
• Results Michel T, Smith TW. Nitric oxide synthases and cardiovascular signaling. Am J Cardiol. 1993 Sep 9;72(8):33C-38C. doi: 10.1016/0002-9149(93)90253-9.
• Results Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Control Clin Trials. 2000 Dec;21(6):552-60. doi: 10.1016/s0197-2456(00)00104-5.
• Results Wagaarachchi PT, Ashok PW, Narvekar NN, Smith NC, Templeton A. Medical management of late intrauterine death using a combination of mifepristone and misoprostol. BJOG. 2002 Apr;109(4):443-7. doi: 10.1111/j.1471-0528.2002.01238.x.
• Results Espey MG, Miranda KM, Feelisch M, Fukuto J, Grisham MB, Vitek MP, Wink DA. Mechanisms of cell death governed by the balance between nitrosative and oxidative stress. Ann N Y Acad Sci. 2000;899:209-21. doi: 10.1111/j.1749-6632.2000.tb06188.x.
• Results Rapoport RM, Draznin MB, Murad F. Endothelium-dependent vasodilator-and nitrovasodilator-induced relaxation may be mediated through cyclic GMP formation and cyclic GMP-dependent protein phosphorylation. Trans Assoc Am Physicians. 1983;96:19-30. No abstract available.
• Results Lokugamage AU, Forsyth SF, Sullivan KR, El Refaey H, Rodeck CH. Randomized trial in multiparous patients: investigating a single vs. two-dose regimen of intravaginal misoprostol for induction of labor. Acta Obstet Gynecol Scand. 2003 Feb;82(2):138-42. doi: 10.1034/j.1600-0412.2003.00084.x.
• Results Cabrol D, Dubois C, Cronje H, Gonnet JM, Guillot M, Maria B, Moodley J, Oury JF, Thoulon JM, Treisser A, et al. Induction of labor with mifepristone (RU 486) in intrauterine fetal death. Am J Obstet Gynecol. 1990 Aug;163(2):540-2. doi: 10.1016/0002-9378(90)91193-g.
• Results Urquhart DR, Templeton AA. The use of mifepristone prior to prostaglandin-induced mid-trimester abortion. Hum Reprod. 1990 Oct;5(7):883-6. doi: 10.1093/oxfordjournals.humrep.a137203.
• Results Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.
• Results Mariani Neto C, Leao EJ, Barreto EM, Kenj G, De Aquino MM, Tuffi VH. [Use of misoprostol for labor induction in stillbirth]. Rev Paul Med. 1987 Nov-Dec;105(6):325-8. No abstract available. Portuguese.
• Results Bartha JL, Comino-Delgado R, Garcia-Benasach F, Martinez-Del-Fresno P, Moreno-Corral LJ. Oral misoprostol and intracervical dinoprostone for cervical ripening and labor induction: a randomized comparison. Obstet Gynecol. 2000 Sep;96(3):465-9. doi: 10.1016/s0029-7844(00)00954-6.
• Results Titiz H, Wallace A, Voaklander DC. Manual removal of the placenta--a case control study. Aust N Z J Obstet Gynaecol. 2001 Feb;41(1):41-4. doi: 10.1111/j.1479-828x.2001.tb01292.x.
• Results Gomez Ponce de Leon R, Wing D, Fiala C. Misoprostol for intrauterine fetal death. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S190-3. doi: 10.1016/j.ijgo.2007.09.010. Epub 2007 Oct 24.
• Results 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 Apr;184(5):958-64. doi: 10.1067/mob.2001.111797.
• Arteaga-Troncoso G, Chacon-Calderon AE, Martinez-Herrera FJ, Cruz-Nunez SG, Lopez-Hurtado M, Belmont-Gomez A, Guzman-Grenfell AM, Farfan-Labonne BE, Neri-Mendez CJ, Zea-Prado F, Guerra-Infante FM. A randomized controlled trial comparing isosorbide dinitrate-oxytocin versus misoprostol-oxytocin at management of foetal intrauterine death. PLoS One. 2019 Nov 21;14(11):e0215718. doi: 10.1371/journal.pone.0215718. eCollection 2019.

Drugs

Indications