Maintenance tocolysis, tocolysis in preterm premature rupture of membranes and in cervical cerclage – a Germany-wide survey on the current practice after dissemination of the German guideline

Patrick Stelzl; Sven Kehl; Peter Oppelt; Andreas Mayr; Tobias Fleckenstein; Holger Maul; Sabine Enengl; Richard Berger; Werner Rath

doi:10.1515/jpm-2022-0572

Article

Maintenance tocolysis, tocolysis in preterm premature rupture of membranes and in cervical cerclage – a Germany-wide survey on the current practice after dissemination of the German guideline

Patrick Stelzl , Sven Kehl , Peter Oppelt , Andreas Mayr , Tobias Fleckenstein , Holger Maul , Sabine Enengl , Richard Berger and Werner Rath

Published/Copyright: March 28, 2023

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From the journal Journal of Perinatal Medicine Volume 51 Issue 6

Abstract

Objectives

To investigate the adherence of German perinatal specialist units and those of basic obstetric care to the national guideline we compared data from a nation-wide survey on the practice of maintenance tocolysis, tocolysis in preterm premature rupture of membranes and in the perioperative setting of cervical cerclage, and bedrest during and after tocolysis with recommendations from the current German Guideline 015/025 “Prevention and Treatment of Preterm Birth”.

Methods

A total of 632 obstetric clinics in Germany were approached and received a link to an online questionnaire. Data were descriptively analyzed by performing measures of frequency. To compare two or more groups Fisherʼs exact test was used.

Results

The response rate was 19%; 23 (19.2%) of respondents did not perform maintenance tocolysis, while 97 (80.8%) conducted maintenance tocolysis; 30 (25.0%) of obstetric units performed cervical cerclage without tocolysis and 90 (75.0%) combined cervical cerclage with tocolysis; 11 (9.2%) of respondents did not use tocolytics in patients with preterm premature rupture of membranes, while 109 (90.8%) conducted tocolysis in these patients; 69 (57.5%) of obstetric units did not recommend bed rest during tocolysis, whereas 51 (42.5%) favored bedrest. Perinatal care centers of basic obstetric care recommend bed arrest during tocolysis statistically significant more often to their patients than those of higher perinatal care levels (53.6 vs. 32.8%, p=0.0269).

Conclusions

The results of our survey are in accordance to others from different countries and reveal considerable discrepancies between evidence-based guideline recommendations and daily clinical practice.

Keywords: bed rest; cervical cerclage; German-wide survey; maintenance tocolysis; preterm premature rupture of membranes

Corresponding author: Dr. Patrick Stelzl, Universitätsklinik für Gynäkologie, Geburtshilfe und gynäkologische Endokrinologie, Kepler Universitätsklinikum Johannes Kepler Universität Linz, Altenberger Str. 69, 4040 Linz, Austria; and Frauenklinik, Universitätsklinikum Erlangen, Universitätsstrasse 21 – 23, 91054 Erlangen, Germany, E-mail: patrick.stelzl@kepleruniklinikum.at

Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: Not applicable.

References

1. Liu, L, Johnson, HL, Cousens, S, Perin, J, Scott, S, Lawn, JE, et al.. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet 2012;379:2151–61. https://doi.org/10.1016/s0140-6736(12)60560-1.Search in Google Scholar PubMed

2. Romero, R, Dey, SK, Fisher, SJ. Preterm labor: one syndrome, many causes. Science 2014;345:760–5. https://doi.org/10.1126/science.1251816.Search in Google Scholar PubMed PubMed Central

3. Vogel, JP, Chawanpaiboon, S, Moller, A-B, Watananirun, K, Bonet, M, Lumbiganon, P. The global epidemiology of preterm birth. Best Pract Res Clin Obstet 2018;52:3–12.10.1016/j.bpobgyn.2018.04.003Search in Google Scholar PubMed

4. You, D, Hug, L, Ejdemyr, S, Beise, J. Levels and trends in child mortality. Report 2015. Estimates developed by the UN inter-agency Group for Child Mortality Estimation. New York: United Nations Children’s Fund; 2015.Search in Google Scholar

5. Berger, R, Abele, H, Bahlmann, F, Bedei, I, Doubek, K, Felderhoff-Müser, U, et al.. Prevention and therapy of preterm labour. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry No. 015/025, February 2019) - Part 2 with recommendations on the tertiary prevention of preterm birth and the management of preterm premature rupture of membranes. Geburtshilfe Frauenheilkd 2019;79:813–33. https://doi.org/10.1055/a-0903-2735.Search in Google Scholar PubMed PubMed Central

6. National Collaborating Centre for Women’s and Children’s Health (UK). Preterm labour and birth. London: National Institute for Health and Care Excellence (UK); 2015.Search in Google Scholar

7. Sentilhes, L, Sénat, M-V, Ancel, P-Y, Azria, E, Benoist, G, Blanc, J, et al.. Prevention of spontaneous preterm birth: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol 2017;210:217–24. https://doi.org/10.1016/j.ejogrb.2016.12.035.Search in Google Scholar PubMed

8. RCOG. Green-top Guideline No. 1b Tocolysis for women in preterm labour. London: Royal College of Obstetricians and Gynaecologists (RCOG); 2011.Search in Google Scholar

9. American College of Obstetricians and Gynecologists. Practice bulletin No. 171: management of preterm labor. Obstet Gynecol 2016;128:e155–64. https://doi.org/10.1097/AOG.0000000000001711.Search in Google Scholar PubMed

10. Stelzl, P, Kehl, S, Rath, W. Maintenance tocolysis: a reappraisal of clinical evidence. Arch Gynecol Obstet 2019;300:1189–99. https://doi.org/10.1007/s00404-019-05313-7.Search in Google Scholar PubMed

11. Eleje, GU, Eke, AC, Ikechebelu, JI, Ezebialu, IU, Okam, PC, Ilika, CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev 2020;9:CD012871. https://doi.org/10.1002/14651858.CD012871.pub2.Search in Google Scholar PubMed PubMed Central

12. Smith, J, DeFranco, E. Tocolytics used as adjunctive therapy at the time of cerclage placement: a systematic review. J Perinatol 2015;35:561–5. https://doi.org/10.1038/jp.2015.38.Search in Google Scholar PubMed

13. Lorthe, E, Goffinet, F, Marret, S, Vayssiere, C, Flamant, C, Quere, M, et al.. Tocolysis after preterm premature rupture of membranes and neonatal outcome: a propensity-score analysis. Am J Obstet Gynecol 2017;217:212. https://doi.org/10.1016/j.ajog.2017.04.015.Search in Google Scholar PubMed

14. van Winden, T, Roos, C, Nijman, T, Kleinrouweler, C, Olaru, A, Mol, B, et al.. Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: a propensity score analysis. Eur J Obstet Gynecol Reprod Biol 2020;255:67–73. https://doi.org/10.1016/j.ejogrb.2020.10.015.Search in Google Scholar PubMed

15. Mackeen, AD, Seibel-Seamon, J, Muhammad, J, Baxter, JK, Berghella, V. Tocolytics for preterm premature rupture of membranes. Cochrane Database Syst Rev 2014:CD007062. https://doi.org/10.1002/14651858.CD007062.pub3.Search in Google Scholar PubMed

16. McCarty-Singleton, S, Sciscione, AC. Maternal activity restriction in pregnancy and the prevention of preterm birth: an evidence-based review. Clin Obstetr Gynecol 2014;57:616–27. https://doi.org/10.1097/grf.0000000000000048.Search in Google Scholar PubMed

17. Rousseau, A, Azria, E, Baumann, S, Deneux‐Tharaux, C, Senat, M. Do obstetricians apply the national guidelines? A vignette‐based study assessing practices for the prevention of preterm birth. BJOG An Int J Obstet Gynaecol 2020;127:467–76. https://doi.org/10.1111/1471-0528.16039.Search in Google Scholar PubMed

18. Fox, NS, Gelber, SE, Kalish, RB, Chasen, ST. Contemporary practice patterns and beliefs regarding tocolysis among US maternal–fetal medicine specialists. Obstet Gynecol 2008;112:42–7. https://doi.org/10.1097/aog.0b013e318176158e.Search in Google Scholar

19. Parant, O, Maillard, F, Tsatsaris, V, Delattre, M, Subtil, D, Goffinet, F, et al.. Management of threatened preterm delivery in France: a national practice survey (the EVAPRIMA study). BJOG An Int J Obstet Gynaecol 2008;115:1538–46. https://doi.org/10.1111/j.1471-0528.2008.01929.x.Search in Google Scholar PubMed

20. Parant, O, Deudon, R, Bennevent, J, Viard, C, Damase-Michel, C, Guyard-Boileau, B. Use of calcium channel blockers (CCB) for tocolysis in France and abroad. Journal de gynecologie, obstetrique et biologie de la reproduction 2015;44:312–23. https://doi.org/10.1016/j.jgyn.2014.12.016.Search in Google Scholar PubMed

21. Hui, D, Liu, G, Kavuma, E, Hewson, SA, McKay, D, Hannah, ME. Preterm labour and birth: a survey of clinical practice regarding use of tocolytics, antenatal corticosteroids, and progesterone. J Obstet Gynaecol Can 2007;29:117–24. https://doi.org/10.1016/s1701-2163(16)32384-2.Search in Google Scholar PubMed

22. Cook, CM, Peek, MJ. Survey of the management of preterm labour in Australia and New Zealand in 2002. Aust N Z J Obstet Gynaecol 2004;44:35–8, https://doi.org/10.1111/j.1479-828x.2004.00173.x.Search in Google Scholar PubMed

23. Lee, HH, Yeh, C-C, Yang, S-T, Liu, C-H, Chen, Y-J, Wang, P-H. Tocolytic treatment for the prevention of preterm birth from a Taiwanese perspective: a survey of Taiwanese obstetric specialists. Int J Environ Res Publ Health 2022;19:4222. https://doi.org/10.3390/ijerph19074222.Search in Google Scholar PubMed PubMed Central

24. Nazifovic, E, Husslein, H, Lakovschek, I, Heinzl, F, Wenzel-Schwarz, E, Klaritsch, P, et al.. Differences between evidence-based recommendations and actual clinical practice regarding tocolysis: a prospective multicenter registry study. BMC Pregnancy Childbirth 2018;18:446. https://doi.org/10.1186/s12884-018-2078-5.Search in Google Scholar PubMed PubMed Central

25. Stelzl, P, Kehl, S, Oppelt, P, Maul, H, Enengl, S, Kyvernitakis, I, et al.. Do obstetric units adhere to the evidence-based national guideline? A Germany-wide survey on the current practice of initial tocolysis. Eur J Obstet Gynecol Reprod Biol 2022;270:133–8.10.1016/j.ejogrb.2022.01.006Search in Google Scholar PubMed

26. gBA [Internet]. (German Joint Federal Committee). Guideline for quality assurance on premature and full-term newborns. Available from: https://www.g-ba.de/informationen/richtlinien/41/2018.Search in Google Scholar

27. Diguisto, C, Le Ray, C, Maillard, F, Khoshnood, B, Verspyck, E, Perrotin, F, et al.. Individual and organisational determinants associated with maintenance tocolysis in the management of preterm labour: a multilevel analysis. PLoS One 2012;7:e50788. https://doi.org/10.1371/journal.pone.0050788.Search in Google Scholar PubMed PubMed Central

28. Morfaw, F, Fundoh, M, Bartoszko, J, Mbuagbaw, L, Thabane, L. Using tocolysis in pregnant women with symptomatic placenta praevia does not significantly improve prenatal, perinatal, neonatal and maternal outcomes: a systematic review and meta-analysis. Syst Rev 2018;7:1–11. https://doi.org/10.1186/s13643-018-0923-2.Search in Google Scholar PubMed PubMed Central

29. Shigemi, D, Aso, S, Yasunaga, H. Inappropriate use of ritodrine hydrochloride for threatened preterm birth in Japan: a retrospective cohort study using a national inpatient database. BMC Pregnancy Childbirth 2019;19:1–5. https://doi.org/10.1186/s12884-019-2352-1.Search in Google Scholar PubMed PubMed Central

30. Vliet, E, Dijkema, G, Schuit, E, Heida, K, Roos, C, Post, J, et al.. Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta‐analysis. BJOG An Int J Obstet Gynaecol 2016;123:1753–60. https://doi.org/10.1111/1471-0528.14249.Search in Google Scholar PubMed

31. Rath, W, Kuon, R. Progesterone - effective for tocolysis and maintenance treatment after arrested labour? Geburtshilfe Frauenheilkd 2019;79:834–43.10.1055/a-0829-3992Search in Google Scholar PubMed PubMed Central

32. Goldenberg, RL, Culhane, JF, Iams, JD, Romero, R. Epidemiology and causes of preterm birth. Lancet 2008;371:75–84. https://doi.org/10.1016/s0140-6736(08)60074-4.Search in Google Scholar PubMed PubMed Central

33. Sosa, CG, Althabe, F, Belizán, JM, Bergel, E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane Database Syst Rev 2015;3:CD003581. https://doi.org/10.1002/14651858.CD003581.pub3.Search in Google Scholar PubMed PubMed Central

34. da Silva Lopes, K, Takemoto, Y, Ota, E, Tanigaki, S, Mori, R. Bed rest with and without hospitalisation in multiple pregnancy for improving perinatal outcomes. Cochrane Database Syst Rev 2017;3:CD012031. https://doi.org/10.1002/14651858.CD012031.pub2.Search in Google Scholar PubMed PubMed Central

35. Hobel, CJ, Ross, MG, Bemis, RL, Bragonier, JR, Nessim, S, Sandhu, M, et al.. The West Los Angeles preterm birth prevention project: I. program impact on high-risk women. Am J Obstet Gynecol 1994;170:54–62. https://doi.org/10.1016/s0002-9378(94)70384-1.Search in Google Scholar PubMed

36. Elliott, JP, Miller, HS, Coleman, S, Rhea, D, Abril, D, Hallbauer, K, et al.. A randomized multicenter study to determine the efficacy of activity restriction for preterm labor management in patients testing negative for fetal fibronectin. J Perinatol 2005;25:626–30. https://doi.org/10.1038/sj.jp.7211359.Search in Google Scholar PubMed

Received: 2022-11-25

Accepted: 2023-02-26

Published Online: 2023-03-28

Published in Print: 2023-07-26

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Articles in the same Issue

https://doi.org/10.1515/jpm-2022-0572

Keywords for this article

bed rest; cervical cerclage; German-wide survey; maintenance tocolysis; preterm premature rupture of membranes