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Volume 7, Issue 5 (September - October 2022)                   J Obstet Gynecol Cancer Res 2022, 7(5): 382-390 | Back to browse issues page


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Moshfeghi M, Arjmandifar M, Mohammadi M, Eftekhari M, Rezaie Keikhaie K. Comparing the Efficacy of Pessary as an Adjunctive Therapy after Cerclage, and Cerclage Alone in Prevention of Spontaneous Preterm Birth: A Randomized Controlled Trial. J Obstet Gynecol Cancer Res. 2022; 7 (5) :382-390
URL: http://jogcr.com/article-1-504-en.html
1- Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine ACECR, Tehran, Iran , moshfeghimaryam@yahoo.com
2- Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran
3- Department of Biostatistics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4- School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5- Department of Obstetrics and Gynecology, Zabol University of Medical Sciences, Zabol, Iran
Abstract:   (192 Views)

Background & Objective: The aim of this study was to evaluate the effectiveness of adjunctive pessary therapy after cerclage in increasing the gestational age (GA) to 37 weeks in women with cervical insufficiency (CI).
Materials & Methods: This randomized controlled trial (RCT) was conducted at the infertility department of Royan Institute, Tehran, Iran. A total of 170 singleton pregnant women aged 18-42 years old, diagnosed with CI by GA 14-24weeks, who had intact membrane with no signs of intrauterine infection, vaginal bleeding, or uterine contraction, were enrolled. Patients were randomized 1:1 to receive either cervical cerclage or pessary after cerclage. The primary outcome was spontaneous preterm birth (SPB) (<37weeks). The secondary outcomes were GA at the time of delivery, SPB (less than 34, 32 & 28 weeks), delivery method, neonatal outcomes, maternal adverse events, and maternal satisfaction with the intervention.
Results: The incidence of SPB (<37, 34, 32 & 28weeks), method of delivery, GA at time of delivery, and neonatal outcomes were not significantly different between the two groups. The incidence of vaginal bleeding (P=0.007) and pelvic pain (P=0.03) significantly was less in the intervention group. The mean score of satisfaction in the intervention group was significantly higher than the control group (P=0.01).
Conclusion: The placement of an adjunctive pessary for pregnant women with singleton pregnancy and CI, did not result in a lower rate of SPB (<37weeks) compared to cerclage alone. However, pregnancy complications after the intervention until delivery were less in these women, while the level of satisfaction was higher.

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Systematic Review: Original Research | Subject: Maternal Fetal Medicine
Received: 2021/09/22 | Accepted: 2022/01/29 | Published: 2022/07/7

References
1. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. The lancet. 2008;371(9606):75-84. [DOI:10.1016/S0140-6736(08)60074-4]
2. Vakilian K, Ranjbaran M, Khorsandi M, Sharafkhani N, Khodadost M. Prevalence of preterm labor in Iran: A systematic review and meta-analysis. Int J Reprod Biomed. 2015;13(12):743. [DOI:10.29252/ijrm.13.12.743] [PMID] [PMCID]
3. Hille ET, Weisglas-Kuperus N, Van Goudoever J, Jacobusse GW, Ens-Dokkum MH, de Groot L, et al. Functional outcomes and participation in young adulthood for very preterm and very low birth weight infants: the Dutch Project on Preterm and Small for Gestational Age Infants at 19 years of age. Pediatrics. 2007;120(3):e587-e95. [DOI:10.1542/peds.2006-2407] [PMID]
4. Mwaniki MK, Atieno M, Lawn JE, Newton CR. Long-term neurodevelopmental outcomes after intrauterine and neonatal insults: a systematic review. The Lancet. 2012;379(9814):445-52. [DOI:10.1016/S0140-6736(11)61577-8]
5. Drakeley AJ, Roberts D, Alfirevic Z. Cervical stitch (cerclage) for preventing pregnancy loss in women. Cochrane Database Syst Rev. 2003(1). [DOI:10.1002/14651858.CD003253] [PMID] [PMCID]
6. Daskalakis G, Papantoniou N, Mesogitis S, Antsaklis A. Management of cervical insufficiency and bulging fetal membranes. Obstet Gynecol. 2006;107(2):221-6. [DOI:10.1097/01.AOG.0000187896.04535.e6] [PMID]
7. El-Nashar SA, Paraiso MF, Rodewald K, Muir T, AbdelHafez F, Lazebnik N, et al. Laparoscopic cervicoisthmic cerclage: technique and systematic review of the literature. Gynecol Obstet Invest. 2013;75(1):1-8. [DOI:10.1159/000343036] [PMID]
8. Rust O, Odibo A. American College of Obstetricians and Gynaecologists Practice Bulletin No. 142: Cerclage for management of cervical insufficiency. Obstet Gynecol. 2014;123(2 Pt 1):372-9. [DOI:10.1097/01.AOG.0000443276.68274.cc] [PMID]
9. Marret S, Ancel PY, Marpeau L, Marchand L, Pierrat V, Larroque B, et al. Neonatal and 5-year outcomes after birth at 30-34 weeks of gestation. Obstet Gynecol. 2007;110(1):72-80. [DOI:10.1097/01.AOG.0000267498.95402.bd] [PMID]
10. Laughon SK, Reddy UM, Sun L, Zhang J. Precursors for late preterm birth in singleton gestations. Obstet Gynecol. 2010;116(5):1047. [DOI:10.1097/AOG.0b013e3181f73f97] [PMID] [PMCID]
11. Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-85. [DOI:10.1056/NEJMoa035140] [PMID]
12. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007;357(5):462-9. [DOI:10.1056/NEJMoa067815] [PMID]
13. Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double‐blind, placebo‐controlled trial. Ultrasound Obstet Gynecol. 2011;38(1):18-31. [DOI:10.1002/uog.9017] [PMID] [PMCID]
14. Visintine J, Airoldi J, Berghella V. Indomethacin administration at the time of ultrasound-indicated cerclage: is there an association with a reduction in spontaneous preterm birth? Am J Obstet Gynecol. 2008;198(6):643.e1-643.e3. [DOI:10.1016/j.ajog.2007.11.052] [PMID]
15. Berghella V, Prasertcharoensuk W, Cotter A, Rasanen J, Mittal S, Chaithongwongwatthana S, et al. Does indomethacin prevent preterm birth in women with cervical dilatation in the second trimester? Am J Perinatol. 2009;26(1):013-019. [DOI:10.1055/s-0028-1091398] [PMID]
16. Flenady V, Hawley G, Stock OM, Kenyon S, Badawi N. Prophylactic antibiotics for inhibiting preterm labour with intact membranes. Cochrane Database Syst Rev. 2013(12). [DOI:10.1002/14651858.CD000246.pub2] [PMCID]
17. Kovacevich GJ, Gaich SA, Lavin JP, Hopkins MP, Crane SS, Stewart J, et al. The prevalence of thromboembolic events among women with extended bed rest prescribed as part of the treatment for premature labor or preterm premature rupture of membranes. Am J Obstet Gynecol. 2000;182(5):1089-92. [DOI:10.1067/mob.2000.105405] [PMID]
18. Maloni JA. Antepartum bed rest for pregnancy complications: efficacy and safety for preventing preterm birth. Biol Res Nurs. 2010;12(2):106-24. [DOI:10.1177/1099800410375978] [PMID]
19. Cross RG. Treatment of habitual abortion due to cervical incompetence. The Lancet. 1959;274(7094):127. [DOI:10.1016/S0140-6736(59)92242-1]
20. Abdel‐Aleem H, Shaaban OM, Abdel‐Aleem MA. Cervical pessary for preventing preterm birth. Cochrane Database Syst Rev. 2013(5). [DOI:10.1002/14651858.CD007873.pub3]
21. Arabin B, Alfirevic Z. Cervical pessaries for prevention of spontaneous preterm birth: past, present and future. Ultrasound Obstet Gynecol. 2013;42(4):390-9. [DOI:10.1002/uog.12540] [PMID] [PMCID]
22. Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, et al. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012;379(9828):1800-6. [DOI:10.1016/S0140-6736(12)60030-0]
23. Saccone G, Maruotti GM, Giudicepietro A, Martinelli P. Effect of cervical pessary on spontaneous preterm birth in women with singleton pregnancies and short cervical length: a randomized clinical trial. JAMA. 2017;318(23):2317-24. [DOI:10.1001/jama.2017.18956] [PMID] [PMCID]
24. Naeiji Z, Heydari S, Bahaar M, Mirzamoradi M, Moridi A, Fathi M. Efficacy and Safety of Cervical Pessary in Decreasing the Preterm Labor in Symptomatic Pregnant Women: A Randomized Clinical Trial. J Obstet Gynecol and Cancer Res (JOGCR). 2021;6(4):195-201. [DOI:10.30699/jogcr.6.4.195]
25. Rezaie Kahkha L, Shahraki Z, Esbati S, Afshari M, Kamali A, Shirazi M, et al. Accuracy of the anterior uterocervical angle in predicting the transvaginal cerclage failure to prevent spontaneous preterm birth relative to the cervical length in sonography. J Obstet Gynecol and Cancer Res (JOGCR). 2021;6(4):181-7. [DOI:10.30699/jogcr.6.4.181]
26. Hui SY, Chor CM, Lau TK, Lao TT, Leung TY. Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial. Am J Perinatol. 2013;30(04):283-8. [DOI:10.1055/s-0032-1322550] [PMID]
27. Kosinska-Kaczynska K, Bomba-Opon D, Zygula A, Kaczynski B, Wegrzyn P, Wielgos M. Adjunctive pessary therapy after emergency cervical cerclage for cervical insufficiency with protruding fetal membranes in the second trimester of pregnancy: a novel modification of treatment. Biomed Res Int. 2015;2015. [DOI:10.1155/2015/185371] [PMID] [PMCID]
28. Altman DG, Bland JM. Treatment allocation in controlled trials: why randomise? Bmj. 1999;318(7192):1209. [DOI:10.1136/bmj.318.7192.1209] [PMID] [PMCID]
29. Final report of the Medical Research Council/Royal College of Obstetricians and Gynaecologists multicentre randomised trial of cervical cerclage. Br J Obstet Gynaecol. 1993;100(6):516-23. [DOI:10.1111/j.1471-0528.1993.tb15300.x] [PMID]
30. Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, et al. The length of the cervix and the risk of spontaneous premature delivery. N Engl J Med. 1996;334(9):567-73. [DOI:10.1056/NEJM199602293340904] [PMID]
31. DeFranco EA, Valent AM, Newman T, Regan J, Smith J, Muglia LJ. Adjunctive therapies to cerclage for the prevention of preterm birth: a systematic review. Obstet Gynecol Int. 2013;2013. [DOI:10.1155/2013/528158] [PMID] [PMCID]
32. Timofeev J. Use of Cervical Pessary in the Management of Cervical Insufficiency. Clin Obstet Gynecol. 2016;59(2):311-9. [DOI:10.1097/GRF.0000000000000196] [PMID]
33. Arabin B, Halbesma JR, Vork F, Hübener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. [DOI:10.1515/JPM.2003.017] [PMID]

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