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The Role Of Tocolytic Agents and Calcium Channel Blockers (Nifedipine) In Preterm Birth Management

Year 2020, Volume: 17 Issue: 4, 621 - 628, 31.12.2020

Seyit Ahmet Erol , Ayşe Kırbaş , Yaprak Ustun

https://doi.org/10.38136/jgon.670061
Cited By: 2

Abstract

Preterm birth is an important risk factor for neonatal
morbidity and mortality. Calcium channel blockers (nifedipine) are safe and
these agents are preferred frequently in medical treatment of preterm labor. Due
to lack of license, they may use off-label in the treatment of preterm labor. In
this review, current literature on tocolytic agents and nifedipine used in the
treatment of preterm delivery is presented.

Keywords

Preterm birth tocolysis calcium channel blockers nifedipine

References

  • 1-Practice Bulletin No. 171: Management of Preterm Labor. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi:10.1097/AOG.0000000000001711. Review.
  • 2- Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications, Lancet 379:2162–2172, 2012.
  • 3- Prevention and Management of Preterm Parturition. In: Resnik R, Lockwood CJ, Moore TR, Greene MF, Copel JA, Silver RM, et al. Creasy and Resnik’s Maternal-Fetal Medicine: Principles and Practice, 8th Edition. Elsevier; 2019, 679-700.
  • 4-Preterm Birth. In: Cunningham FG, Leveno JK, Bloom SL, Dashe SJ, Hoffman BL, Casey BM, et al. Williams Obstetrics, 25th Edition. McGraw-Hill Education; 2018, 804-828.
  • 5-Matthews TJ, MacDorman MF, Thoma ME. Infant Mortality Statistics From the 2013 Period Linked Birth/Infant Death Data Set.Natl Vital Stat Rep. 2015 Aug 6;64(9):1-30.
  • 6-Frey HA, Klebanoff MA. The epidemiology, etiology, and costs of preterm birth. Semin Fetal Neonatal Med. 2016 Apr;21(2):68-73. doi: 10.1016/j.siny.2015.12.011.
  • 7-Younge N, Goldstein RF, Bann CM, Hintz SR, Patel RM, Smith PB, Bell EF, et al. Survival and neurodevelopmental outcomes among periviable infants. N Engl J Med. 2017 Feb 16;376(7):617-628. doi: 10.1056/NEJMoa1605566.
  • 8-Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008 Apr 17;358(16):1700-11. doi: 10.1056/NEJMra0707601.
  • 9- Goldenberg RL. The management of preterm labor. Obstet Gynecol. 2002 Nov;100(5 Pt 1):1020-37.
  • 10- Walker KF, Thornton JG. Tocolysis and preterm labour. Lancet. 2016 May 21;387(10033):2068-2070. doi: 10.1016/S0140-6736(16)00590-0
  • 11- Preterm Labour and Birth.National Collaborating Centre for Women's and Children's Health (UK).London: National Institute for Health and Care Excellence (UK); 2015 Nov.
  • 12- Lamont CD, Jørgensen JS, Lamont RF. The safety of tocolytics used for the inhibition of preterm labour. Review, Expert Opin Drug Saf. 2016 Sep;15(9):1163-73. doi: 10.1080/14740338.2016.1187128
  • 13- Lewis R, Mercer BM, Salama M, Walsh MA, Sibai BM. Oral terbutaline after parenteral tocolysis: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1996 Oct;175(4 Pt 1):834-7.
  • 14-Cotton DB, Strassner HT, Hill LM, Schifrin BS, Paul RH. Comparison between magnesium sulfate, terbutaline and a placebo for inhibition of preterm labor: a randomized study. J Reprod Med. 1984 Feb;29(2):92-7.
  • 15- Cox SM, Sherman ML, Leveno KJ. Randomized investigation of magnesium sulfate for prevention of preterm birth. Am J Obstet Gynecol. 1990 Sep;163(3):767-72.
  • 16- Crowther CA, Brown J, McKinlay CJ, Middleton P. Magnesium sulphate for preventing preterm birth in threatened preterm labour. Cochrane Database Syst Rev. 2014 Aug 15;(8):CD001060. doi: 10.1002/14651858.CD001060.pub2. Review.
  • 17- Food and Drug Administration: FDA drug safety communication: FDA recommends against prolonged use of magnesium sulfate to stop pre-term labor due to bone changes in exposed babies. May 30, 2013. Available at: http://www.fda.gov/drugs/drugsafety/ucm35333.htmAccessed November 9, 2017
  • 18- Morales WJ, Madhav H. Efficacy and safety of indomethacin compared with magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993 Jul;169(1):97-102.
  • 19-Berghella V, Rust OA, Althuisius SM. Short cervix on ultrasound: does indomethacin prevent preterm birth?Am J Obstet Gynecol. 2006 Sep;195(3):809-13.
  • 20- Norton ME, Merrill J, Cooper BA, Kuller JA, Clyman RI. Neonatal complications after the administration of indomethacin for preterm labor. N Engl J Med. 1993 Nov 25;329(22):1602-7.
  • 21- Amin SB, Sinkin RA, Glantz JC. Metaanalysis of the effect of antenatal indomethacin on neonatal outcomes. Am J Obstet Gynecol. 2007 Nov;197(5):486.e1-10.
  • 22- Reinebrant HE, Pileggi-Castro C, Romero CL, Dos Santos RA, Kumar S, Souza JP, Flenady V. Cyclo-oxygenase (COX) inhibitors for treating preterm labour. Cochrane Database Syst Rev. 2015 Jun 5;(6):CD001992. doi: 10.1002/14651858.CD001992.pub3. Review.
  • 23- Bisits A, Madsen G, Knox M, Gill A, Smith R, Yeo G, et al. The randomized nitric oxide tocolysis trial (RNOTT) for the treatment of preterm labor. Am J Obstet Gynecol. 2004 Sep;191(3):683-90.
  • 24- Romero R, Sibai BM, Sanchez-Ramos L, Valenzuela GJ, Veille JC, Tabor B, et al. An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue. Am J Obstet Gynecol. 2000 May;182(5):1173-83.
  • 25- Flenady V, Reinebrant HE, Liley HG, Tambimuttu EG, Papatsonis DN. Oxytocin receptor antagonists for inhibiting preterm labour. Cochrane Database Syst Rev. 2014 Jun 6;(6):CD004452. doi: 10.1002/14651858.CD004452.pub3. Review.
  • 26- Oei SG. Calcium channel blockers for tocolysis: a review of their role and safety following reports of serious adverse events, Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):137-45. Epub 2006 Mar 29.
  • 27-Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, et al. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7.
  • 28-Salim R, Garmi G, Nachum Z, Zafran N, Baram S, Shalev E. Nifedipine compared with atosiban for treating preterm labor: a randomized controlled trial. Obstet Gynecol. 2012 Dec;120(6):1323-31. doi: http://10.1097/AOG.0b013e3182755dff.
  • 29- Klauser CK, Briery CM, Martin RW, Langston L, Magann EF, Morrison JC. A comparison of three tocolytics for preterm labor: a randomized clinical trial J Matern Fetal Neonatal Med. 2014 May;27(8):801-6. doi: 10.3109/14767058.2013.847416.
  • 30- Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
  • 31- How HY, Zafaranchi L, Stella CL, Recht K, Maxwell RA, Sibai BM, Spinnato JA. Tocolysis in women with preterm labor between 32 0/7 and 34 6/7 weeks of gestation: a randomized controlled pilot study. Am J Obstet Gynecol. 2006 Apr;194(4):976-81.
  • 32- Vis JY, van Baaren GJ, Wilms FF, Oudijk MA, Kwee A, Porath MM et al.Randomized comparison of nifedipine and placebo in fibronectin-negative women with symptoms of preterm labor and a short cervix (APOSTEL-I Trial).Am J Perinatol. 2015 Apr;32(5):451-60. doi: 10.1055/s-0034-1390346.
  • 33- Roos C, Spaanderman ME, Schuit E, Bloemenkamp KW, Bolte AC, Cornette J et al.Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial. JAMA. 2013 Jan 2;309(1):41-7. doi: 10.1001/jama.2012.153817.
  • 34- van Vliet EOG, Nijman TAJ, Schuit E, Heida KY, Opmeer BC, Kok M, et al. Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial. Lancet. 2016 May 21;387(10033):2117-2124. doi: 10.1016/S0140-6736(16)00548-1.
  • 35- Nijman TAJ, Goedhart MM, Naaktgeboren CN, de Haan TR, Vijlbrief DC, Mol BW, et al.Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL-III trial.Ultrasound Obstet Gynecol. 2018 Jun;51(6):806-812. doi: 10.1002/uog.17512.
  • 36- Nijman T, van Baaren GJ, van Vliet E, Kok M, Gyselaers W, Porath MM, et al.Cost effectiveness of nifedipine compared with atosiban in the treatment of threatened preterm birth (APOSTEL III trial).BJOG. 2019 Jun;126(7):875-883. doi: 10.1111/1471-0528.15625.
  • 37- Hermans FJ, Schuit E, Opmeer BC, Oudijk MA, Bekker M, Woiski M, et al. Effectiveness of a cervical pessary for women who did not deliver 48 h after threatened preterm labor (Assessment of perinatal outcome after specific treatment in early labor: Apostel VI trial).BMC Pregnancy Childbirth. 2016 Jul 12;16(1):154. doi: 10.1186/s12884-016-0935-7.
  • 38- Klumper J, Breebaart W, Roos C, Naaktgeboren CA, van der Post J, Bosmans J, et al.Study protocol for a randomised trial for atosiban versus placebo in threatened preterm birth: the APOSTEL 8 study.BMJ Open. 2019 Nov 26;9(11):e029101. doi: 10.1136/bmjopen-2019-029101.

Preterm Doğum Yönetiminde Tokolitik Ajanlar ve Kalsiyum Kanal Blokerlerinin (Nifedipin) Yeri

Year 2020, Volume: 17 Issue: 4, 621 - 628, 31.12.2020

Seyit Ahmet Erol , Ayşe Kırbaş , Yaprak Ustun

https://doi.org/10.38136/jgon.670061
Cited By: 2

Abstract

Preterm doğum, neonatal morbidite ve mortalite yönünden önemli bir risk faktörüdür. Kalsiyum kanal blokerleri (nifedipin) preterm doğum medikal tedavisinde kullanımı güvenlidir ve uluslararası kılavuzlarda sık tercih edilen ajanlardan birisidir. Ruhsatlanımı olmaması nedeniyle preterm doğum tedavisinde endikasyon dışı (off-label) kullanılmaktadır. Bu derlemede preterm doğum tedavisinde kullanılan tokolitik ajanlar ve nifedipin ile ilgili güncel literatür sunulmuştur.

Keywords

Preterm doğum tokoliz kalsiyum kanal blokerler nifedipin

References

  • 1-Practice Bulletin No. 171: Management of Preterm Labor. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi:10.1097/AOG.0000000000001711. Review.
  • 2- Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications, Lancet 379:2162–2172, 2012.
  • 3- Prevention and Management of Preterm Parturition. In: Resnik R, Lockwood CJ, Moore TR, Greene MF, Copel JA, Silver RM, et al. Creasy and Resnik’s Maternal-Fetal Medicine: Principles and Practice, 8th Edition. Elsevier; 2019, 679-700.
  • 4-Preterm Birth. In: Cunningham FG, Leveno JK, Bloom SL, Dashe SJ, Hoffman BL, Casey BM, et al. Williams Obstetrics, 25th Edition. McGraw-Hill Education; 2018, 804-828.
  • 5-Matthews TJ, MacDorman MF, Thoma ME. Infant Mortality Statistics From the 2013 Period Linked Birth/Infant Death Data Set.Natl Vital Stat Rep. 2015 Aug 6;64(9):1-30.
  • 6-Frey HA, Klebanoff MA. The epidemiology, etiology, and costs of preterm birth. Semin Fetal Neonatal Med. 2016 Apr;21(2):68-73. doi: 10.1016/j.siny.2015.12.011.
  • 7-Younge N, Goldstein RF, Bann CM, Hintz SR, Patel RM, Smith PB, Bell EF, et al. Survival and neurodevelopmental outcomes among periviable infants. N Engl J Med. 2017 Feb 16;376(7):617-628. doi: 10.1056/NEJMoa1605566.
  • 8-Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008 Apr 17;358(16):1700-11. doi: 10.1056/NEJMra0707601.
  • 9- Goldenberg RL. The management of preterm labor. Obstet Gynecol. 2002 Nov;100(5 Pt 1):1020-37.
  • 10- Walker KF, Thornton JG. Tocolysis and preterm labour. Lancet. 2016 May 21;387(10033):2068-2070. doi: 10.1016/S0140-6736(16)00590-0
  • 11- Preterm Labour and Birth.National Collaborating Centre for Women's and Children's Health (UK).London: National Institute for Health and Care Excellence (UK); 2015 Nov.
  • 12- Lamont CD, Jørgensen JS, Lamont RF. The safety of tocolytics used for the inhibition of preterm labour. Review, Expert Opin Drug Saf. 2016 Sep;15(9):1163-73. doi: 10.1080/14740338.2016.1187128
  • 13- Lewis R, Mercer BM, Salama M, Walsh MA, Sibai BM. Oral terbutaline after parenteral tocolysis: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1996 Oct;175(4 Pt 1):834-7.
  • 14-Cotton DB, Strassner HT, Hill LM, Schifrin BS, Paul RH. Comparison between magnesium sulfate, terbutaline and a placebo for inhibition of preterm labor: a randomized study. J Reprod Med. 1984 Feb;29(2):92-7.
  • 15- Cox SM, Sherman ML, Leveno KJ. Randomized investigation of magnesium sulfate for prevention of preterm birth. Am J Obstet Gynecol. 1990 Sep;163(3):767-72.
  • 16- Crowther CA, Brown J, McKinlay CJ, Middleton P. Magnesium sulphate for preventing preterm birth in threatened preterm labour. Cochrane Database Syst Rev. 2014 Aug 15;(8):CD001060. doi: 10.1002/14651858.CD001060.pub2. Review.
  • 17- Food and Drug Administration: FDA drug safety communication: FDA recommends against prolonged use of magnesium sulfate to stop pre-term labor due to bone changes in exposed babies. May 30, 2013. Available at: http://www.fda.gov/drugs/drugsafety/ucm35333.htmAccessed November 9, 2017
  • 18- Morales WJ, Madhav H. Efficacy and safety of indomethacin compared with magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993 Jul;169(1):97-102.
  • 19-Berghella V, Rust OA, Althuisius SM. Short cervix on ultrasound: does indomethacin prevent preterm birth?Am J Obstet Gynecol. 2006 Sep;195(3):809-13.
  • 20- Norton ME, Merrill J, Cooper BA, Kuller JA, Clyman RI. Neonatal complications after the administration of indomethacin for preterm labor. N Engl J Med. 1993 Nov 25;329(22):1602-7.
  • 21- Amin SB, Sinkin RA, Glantz JC. Metaanalysis of the effect of antenatal indomethacin on neonatal outcomes. Am J Obstet Gynecol. 2007 Nov;197(5):486.e1-10.
  • 22- Reinebrant HE, Pileggi-Castro C, Romero CL, Dos Santos RA, Kumar S, Souza JP, Flenady V. Cyclo-oxygenase (COX) inhibitors for treating preterm labour. Cochrane Database Syst Rev. 2015 Jun 5;(6):CD001992. doi: 10.1002/14651858.CD001992.pub3. Review.
  • 23- Bisits A, Madsen G, Knox M, Gill A, Smith R, Yeo G, et al. The randomized nitric oxide tocolysis trial (RNOTT) for the treatment of preterm labor. Am J Obstet Gynecol. 2004 Sep;191(3):683-90.
  • 24- Romero R, Sibai BM, Sanchez-Ramos L, Valenzuela GJ, Veille JC, Tabor B, et al. An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue. Am J Obstet Gynecol. 2000 May;182(5):1173-83.
  • 25- Flenady V, Reinebrant HE, Liley HG, Tambimuttu EG, Papatsonis DN. Oxytocin receptor antagonists for inhibiting preterm labour. Cochrane Database Syst Rev. 2014 Jun 6;(6):CD004452. doi: 10.1002/14651858.CD004452.pub3. Review.
  • 26- Oei SG. Calcium channel blockers for tocolysis: a review of their role and safety following reports of serious adverse events, Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):137-45. Epub 2006 Mar 29.
  • 27-Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, et al. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7.
  • 28-Salim R, Garmi G, Nachum Z, Zafran N, Baram S, Shalev E. Nifedipine compared with atosiban for treating preterm labor: a randomized controlled trial. Obstet Gynecol. 2012 Dec;120(6):1323-31. doi: http://10.1097/AOG.0b013e3182755dff.
  • 29- Klauser CK, Briery CM, Martin RW, Langston L, Magann EF, Morrison JC. A comparison of three tocolytics for preterm labor: a randomized clinical trial J Matern Fetal Neonatal Med. 2014 May;27(8):801-6. doi: 10.3109/14767058.2013.847416.
  • 30- Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
  • 31- How HY, Zafaranchi L, Stella CL, Recht K, Maxwell RA, Sibai BM, Spinnato JA. Tocolysis in women with preterm labor between 32 0/7 and 34 6/7 weeks of gestation: a randomized controlled pilot study. Am J Obstet Gynecol. 2006 Apr;194(4):976-81.
  • 32- Vis JY, van Baaren GJ, Wilms FF, Oudijk MA, Kwee A, Porath MM et al.Randomized comparison of nifedipine and placebo in fibronectin-negative women with symptoms of preterm labor and a short cervix (APOSTEL-I Trial).Am J Perinatol. 2015 Apr;32(5):451-60. doi: 10.1055/s-0034-1390346.
  • 33- Roos C, Spaanderman ME, Schuit E, Bloemenkamp KW, Bolte AC, Cornette J et al.Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial. JAMA. 2013 Jan 2;309(1):41-7. doi: 10.1001/jama.2012.153817.
  • 34- van Vliet EOG, Nijman TAJ, Schuit E, Heida KY, Opmeer BC, Kok M, et al. Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial. Lancet. 2016 May 21;387(10033):2117-2124. doi: 10.1016/S0140-6736(16)00548-1.
  • 35- Nijman TAJ, Goedhart MM, Naaktgeboren CN, de Haan TR, Vijlbrief DC, Mol BW, et al.Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL-III trial.Ultrasound Obstet Gynecol. 2018 Jun;51(6):806-812. doi: 10.1002/uog.17512.
  • 36- Nijman T, van Baaren GJ, van Vliet E, Kok M, Gyselaers W, Porath MM, et al.Cost effectiveness of nifedipine compared with atosiban in the treatment of threatened preterm birth (APOSTEL III trial).BJOG. 2019 Jun;126(7):875-883. doi: 10.1111/1471-0528.15625.
  • 37- Hermans FJ, Schuit E, Opmeer BC, Oudijk MA, Bekker M, Woiski M, et al. Effectiveness of a cervical pessary for women who did not deliver 48 h after threatened preterm labor (Assessment of perinatal outcome after specific treatment in early labor: Apostel VI trial).BMC Pregnancy Childbirth. 2016 Jul 12;16(1):154. doi: 10.1186/s12884-016-0935-7.
  • 38- Klumper J, Breebaart W, Roos C, Naaktgeboren CA, van der Post J, Bosmans J, et al.Study protocol for a randomised trial for atosiban versus placebo in threatened preterm birth: the APOSTEL 8 study.BMJ Open. 2019 Nov 26;9(11):e029101. doi: 10.1136/bmjopen-2019-029101.
There are 38 citations in total.

Details

Primary Language Turkish
Subjects Obstetrics and Gynaecology
Journal Section Review
Authors

Seyit Ahmet Erol 0000-0002-2494-4896

Ayşe Kırbaş 0000-0002-4522-9461

Yaprak Ustun 0000-0002-1011-3848

Publication Date December 31, 2020
Submission Date January 3, 2020
Acceptance Date May 14, 2020
Published in Issue Year 2020 Volume: 17 Issue: 4

Cite

Vancouver Erol SA, Kırbaş A, Ustun Y. Preterm Doğum Yönetiminde Tokolitik Ajanlar ve Kalsiyum Kanal Blokerlerinin (Nifedipin) Yeri. JGON. 2020;17(4):621-8.

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