27Mar 2017

PREGNANCY OUTCOME IN SHORT CERVIX: PROGESTERONE VS CERVICAL ENCERCLAGE.

  • Resident, Department of Obstetrics and Gynaecology, BharatiVidyapeeth Deemed University Medical College, Pune, Maharashtra, India.
  • Professor, Department of Obstetrics and Gynaecology, BharatiVidyapeeth Deemed University Medical College, Pune, Maharashtra, India.
  • Abstract
  • Keywords
  • References
  • Cite This Article as
  • Corresponding Author

Introduction: Preterm birth (PTB), defined as birth before 37 weeks of gestation, is the leading cause of perinatal morbidity and mortality. A sonographic short cervix has emerged as a powerful predictor of preterm birth. The present study was conducted to compare the outcome of pregnancy with short cervix with natural micronized progesterone and cervical cerclage. Materials & Methods: A Prospective Comparative study was conducted in the Department of Obstetrics and Gynaecology of a Tertiary Care Hospital and Medical college. A total of 50 cases of short cervix were included in the study. Out of 50 cases, 25 cases each were divided in two groups by simple random sampling: Group A: Given natural micronized progesterone; and Group B: Underwent cerclage procedure. Detailed history, ANC check-up, USG and appropriate investigations were carried out for each subject. The cases were followed thereafter in antenatal clinic till delivery and pregnancy outcome was noted. Results: The mean maternal age was 22.44 years in progesterone group and 22.64 years in cerclage group (p-0.514). The outcome of pregnancy with natural micronised progesterone reflected 36% births between 28-32 weeks of gestation, 28% after completion of 37 weeks and only 16% before 28 weeks of gestation whereas outcome with cerclage 36% between 28-32 weeks, 44% after completion of 37 weeks and 8% before 28 weeks (p-0.56). The difference in secondary outcome measures (PPROM, LSCS rate)and neonatal outcome (mean birth weight, APGAR, duration of NICU admission, respiratory distress, development of IVH, NEC and neonatal sepsis) in cerclage and progesterone group was also statistically non-significant (p>0.05) Conclusion: Natural micronized progesterone is as effective as cervical cerclage in prevention of premature labour in women with short cervix. Use of natural micronized progesterone is more preferable in clinical practice because it is non-invasive technique, easy to administer and the patients do not suffer from surgical and anaesthesia procedure related adverse effects. It is also not associated with any hospital stay and is very economical.


  1. World Health Organization. Manual of the international statistical classification of diseases, injuries, and causes of death. Vol. 1 (9th revision). Geneva (Switzerland): World Health Organization; 1975.
  2. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of pretermbirth. Lancet 2008;371:75-84.
  3. Blencowe H, Cousens S, Chou D. et al. Born Too Soon: The global epidemiology of 15 million preterm births. Reproductive Health 2013,10(S2)
  4. Schaaf JM, Mol BW, Abu-Hanna A, Ravelli AC. Trends in preterm birth: singleton and multiple pregnancies in the Netherlands, 2000-2007.BJOG 2011 Sep;118(10):1196-204.
  5. StichtingPerinataleRegistratie Nederland, PerinataleZorg in Nederland 2010, Utrecht, StichtingPerinataleRegistratie Nederland 2013.
  6. Conde-Agudelo A, Romero R, Nicolaides K, Chaiworapongsa T, O'brien JM, Cetingoz E, da Fonseca E, Creasy G, Soma-Pillay P, Fusey S, Cam C. Vaginal progesterone vs cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis. American journal of obstetrics and gynecology. 2013 Jan 31;208(1):42-e1.
  7. Gomez R, Romero R, Nien JK, et al. Antibioticadministration to patients with preterm prematurerupture of membranes does not eradicateintra-amniotic infection. J MaternFetalNeonatal Med 2007;20:167-73.
  8. Ma S, Yang L, Romero R, Cui Y. Varyingcoefficient model for gene-environment interaction:a non-linear look. Bioinformatics 2011;27:2119-26.
  9. Macones GA, Parry S, Elkousy M, ClothierB, Ural SH, Strauss JF III. A polymorphism inthe promoter region of TNF and bacterialvaginosis: preliminary evidence of gene-environmentinteraction in the etiology of spontaneouspreterm birth. Am J ObstetGynecol2004;190:1504-8; discussion 3A.
  10. Parimi N, Tromp G, Kuivaniemi H, et al. Analyticalapproaches to detect maternal/fetal genotypeincompatibilities that increase risk ofpre-eclampsia. BMC Med Genet 2008;9:60
  11. Csapo AI. The ?see-saw? theory of parturition.Ciba Found Symp 1977;47:159-210.
  12. Kerenyi T. Forgotten ?father of progesterone.?Am J ObstetGynecol 2010;202:e10-1.
  13. Csapo A. The luteo-placental shift, theguardian of pre-natal life. Postgrad Med J1969;45:57-64.
  14. Csapo AI, Pulkkinen MO, Wiest WG. Effectsofluteectomy and progesterone replacement therapy in early pregnant patients. Am J ObstetGynecol 1973;115:759-65.
  15. 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;357:462?9. [PubMed]
  16. Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW. 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;38:18?31.
  17. Romero R. Vaginal progesterone in asymptomatic women with a sonographic short cervix.?Am J Obstet Gynecol.?2012.
  18. Shennan A H, RCOG Green-top guidelines No. 60. Royal College of Obstetricians & Gynaecologists. May 2011:1-21.
  19. 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;357:462?469.
  20. Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW. 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;38:18?31.
  21. Higgins JPT, Altman DG, Sterne JAC. Higgins JPT, Green S, editors. Chapter 8: Assessing risk of bias in included studies. Cochrane Handbook for Systematic Reviews of Interventions Version 510 (updated March 2011) The Cochrane Collaboration 2011. 2011
  22. Stewart LA, Parmar MK. Meta-analysis of the literature or of individual patient data: is there a difference? Lancet. 1993;341:418?422.
  23. Thompson SG, Higgins JP. Treating individuals 4: can meta-analysis help target interventions at individuals most likely to benefit? Lancet. 2005;365:341?346. [PubMed]
  24. Sutton AJ, Kendrick D, Coupland CA. Meta-analysis of individual- and aggregate-level data. Stat Med. 2008;27:651?669.
  25. Riley RD, Lambert PC, Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ. 2010;340:c221.
  26. Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012;206:124. e1?19.
  27. O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007;30:687?696.
  28. Rode L, Klein K, Nicolaides K, Krampl-Bettelheim E, Tabor A. Prevention of preterm delivery in twin gestations (PREDICT): A multicentrerandomised placebo-controlled trial on the effect of vaginal micronised progesterone. Ultrasound Obstet Gynecol. 2011;38:272?280.
  29. Cetingoz E, Cam C, Sakalli M, Karateke A, Celik C, Sancak A. Progesterone effects on preterm birth in high-risk pregnancies: a randomized placebo-controlled trial. Arch Gynecol Obstet. 2011;283:423?429.
  30. Shirodkar VN, et al. A new method of operative treatment for habitual abortions in the second trimester of pregnancy.?Antiseptic.?1955;52:299?300
  31. To MS, Alfirevic Z, Heath VC, Cicero S, Cacho AM, Williamson PR, Nicolaides KH. Cervical cerclage for prevention of preterm delivery in women with short cervix: randomised controlled trial. Lancet. 2004;363:1849?1853.
  32. Althuisius S, Dekker G, Hummel P, Bekedam D, Kuik D, van Geijn H. Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): effect of therapeutic cerclage with bed rest vs. bed rest only on cervical length. Ultrasound Obstet Gynecol. 2002;20:163?167.
  33. Althuisius SM, Dekker GA, Hummel P, Bekedam DJ, van Geijn HP. Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): therapeutic cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol. 2001;185:1106?1112.
  34. Final report of the Medical Research Council/Royal College of Obstetricians and Gynaecologistsmulticentrerandomised trial of cervical cerclage. MRC/RCOG Working Party on Cervical Cerclage. Br J ObstetGynaecol. 1993;100:516?523.
  35. Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol. 2011;117:663?671.
  36. Rust OA, Atlas RO, Reed J, van Gaalen J, Balducci J. Revisiting the short cervix detected by transvaginal ultrasound in the second trimester: why cerclage therapy may not help. Am J Obstet Gynecol. 2001;185:1098?1105.
  37. Berghella V, Odibo AO, Tolosa JE. Cerclage for prevention of preterm birth in women with a short cervix found on transvaginal ultrasound examination: a randomized trial. Am J Obstet Gynecol. 2004;191:1311?1317.
  38. Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009;201:375. e1?8.
  39. Berghella V, Mackeen AD. Cervical length screening with ultrasound-indicated cerclage compared with history-indicated cerclage for prevention of preterm birth: a meta-analysis. Obstet Gynecol. 2011;118:148?155.
  40. Keeler SM, Kiefer D, Rochon M, et al 2009 : A randomized trial of cerclage vs. 17alpha-hydroxyprogesteronecaproate fortreatment of short cervix. J PerinatMed.;37(5):473-9
  41. Conde-Agudelo A, Romero R, Nicolaides K, et al. Vaginal progesterone versus cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, singleton gestation, and previous preterm birth: A systematic review and indirect comparison meta-analysis.?American journal of obstetrics and gynecology. 2013;208(1):42-48.

[Nikita Gandotra and Vandana Nimbargi. (2017); PREGNANCY OUTCOME IN SHORT CERVIX: PROGESTERONE VS CERVICAL ENCERCLAGE. Int. J. of Adv. Res. 5 (Mar). 1144-1150] (ISSN 2320-5407). www.journalijar.com


Dr. Nikita Gadotra
Department of Obstetrics and Gynaecology, BharatiVidyapeeth Deemed University Medical College, Pune, Maharashtra, India

DOI:


Article DOI: 10.21474/IJAR01/3618      
DOI URL: https://dx.doi.org/10.21474/IJAR01/3618