Sublingual Misoprostol versus Foley catheter for cervical ripening in women with preeclampsia or gestational hypertension: A randomized control trial

Abstract

Background: Delivery is the only definite cure for hypertensive disorders. Therefore, cervical ripening and labor induction are important to achieve favorable outcomes.


Objective: This Randomized Control Trial (RCT) is aimed to compare the effects of sublingual misoprostol and Foley catheter in cervical ripening and labor induction among patients with preeclampsia or gestational hypertension.


Materials and Methods: A total number of 144 women with preeclampsia or gestational hypertention with indication of pregnancy termination, who were referred to academic hospitals of the University of Medical Sciences in Mashhad, Iran, between March 2015 and December 2016, were randomly divided into two groups. In group one (n = 72), 25 μg of misoprostol tablet was administrated sublingually every 4 hr up to six doses. In group two (n = 72), a 16F Foley catheter was placed through the internal cervical os, inflated with 60 cc of sterile saline.


Results: There were no significant differences between groups regarding the demographic characteristics, primary bishop score, and pregnancy termination indication. The cervical ripening time (primary outcome) (8.2 vs 14.2 hr, p < 0.00), induction to delivery interval (15.5 vs 19.9 hr, p < 0.00), and vaginal delivery before 24 hr (63.9% vs 40%, p = 0.03) were significantly different between the two groups. There was no significant difference between groups in view of oxytocin requirement (p = 0.12), neonatal Apgar score (p = 0.84), or neonatal intensive care unit admission (p = 78).


Conclusion: This trial showed that the application of sublingual misoprostol, compared to the Foley catheter, can reduce cervical ripening period and other parameters related to the duration of vaginal delivery. This misoprostol regimen showed inconsiderable maternal complications.

References
[1] Cunningham FG, Leveno KJ, Bloom SL, Spong CY, Dashe JS, Hoffman BL, et al. Williams Obstetrics. 24th Ed. New York: McGraw-Hill Education; 2014.

[2] Chauhan SP, Ananth CV. Induction of labor in the United States: a critical appraisal of appropriateness and
reducibility. Semin Perinatol 2012; 36: 336–343.

[3] Vahid Roudsari F, Ayati S, Ghasemi M, Hasanzadeh Mofrad M, Shakeri MT, Farshidi F, et al. Comparison of vaginal misoprostol with foley catheter for cervical ripening and induction of labor. Iran J Pharm Res 2011; 10: 149–154.

[4] Adeniji AO, Olayemi O, Odukogbe AA. Intravaginal misoprostol versus transcervical Foley catheter in pre-induction cervical ripening. Int J Gynaecol Obstet 2006; 92: 130– 132.

[5] Adeniji OA, Oladokun A, Olayemi O, Adeniji OI, Odukogbe AA, Ogunbode O, et al. Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol. J Obstet Gynaecol 2005; 25: 134–139.

[6] Aduloju OP, Akintayo AA, Adanikin AI, Ade-Ojo IP. Combined Foley’s catheter with vaginal misoprostol for preinduction cervical ripening: A randomised controlled trial. Aust N Z J Obstet Gynaecol 2016; 56: 578–584.

[7] Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet 2005; 89: 263– 267.

[8] Garba I, Muhammed AS, Muhammad Z, Galadanci HS, Ayyuba R, Abubakar IS. Induction to delivery interval using transcervical Foley catheter plus oxytocin and vaginal misoprostol: A comparative study at Aminu Kano Teaching Hospital, Kano, Nigeria. Ann Afr Med 2016; 15: 114–119.

[9] Jozwiak M, ten Eikelder M, Oude Rengerink K, de Groot C, Feitsma H, Spaanderman M, et al. Foley catheter
versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and metaanalysis of literature. Am J Perinatol 2014; 31: 145–156.

[10] Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol
versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand 2010; 89: 1045–1052.

[11] Noor N, Ansari M, Ali SM, Parveen S. Foley catheter versus vaginal misoprostol for labour induction. Int J Reprod Med 2015; 2015: 845735.

[12] Barrilleaux PS, Bofill JA, Terrone DA, Magann EF, May WL, Morrison JC. Cervical ripening and induction of labor with misoprostol, dinoprostone gel, and a Foley catheter: a randomized trial of 3 techniques. Am J Obstet Gynecol 2002; 186: 1124–1129.

[13] Fox NS, Saltzman DH, Roman AS, Klauser CK, Moshier E, Rebarber A. Intravaginal misoprostol versus Foley catheter for labour induction: a meta-analysis. BJOG 2011; 118: 647– 654.

[14] Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG 2008; 115: 1443–1450.

[15] Chen W, Xue J, Peprah MK, Wen SW, Walker M, Gao Y, et al. A systematic review and network meta-analysis
comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of
labour. BJOG 2016; 123: 346–354.

[16] Chavakula PR, Benjamin SJ, Abraham A, Londhe V, Jeyaseelan V, Mathews JE. Misoprostol versus foley
catheter insertion for induction of labor in pregnancies affected by fetal growth restriction. Int J Gynaecol Obstet
2015; 129: 152–155.

[17] Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, et al. [Cervical Foley catheter versus vaginal
misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet 2010; 32: 346–351.

[18] Owolabi AT, Kuti O, Ogunlola IO. Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour. J Obstet Gynaecol 2005; 25: 565–568.

[19] Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, et al.
Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet 2016; 387: 1619–1628.

[20] Giugliano E, Cagnazzo E, Milillo V, Moscarini M, Vesce F, Caserta D, et al. The risk factors for failure of labor
induction: a cohort study. J Obstet Gynaecol India 2014; 64: 111–115.