Comparison of oral, vaginal and sublingual misoprostol for induction of labour in premature rupture of membranes after 34 weeks of gestation: a randomized controlled trial

Authors

  • Chandana Galidevara Department of Obstetrics and Gynecology, Mahatma Gandhi Medical College and Research Institute, Puducherry, India
  • Latha Chaturvedula Department of Obstetrics and Gynecology, JIPMER, Puducherry, India
  • Syed Habeebullah Department of Obstetrics and Gynecology, JIPMER, Puducherry, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20180958

Keywords:

Induction of labour, Oral misoprostol, Premature rupture of membranes, Sublingual misoprostol, Vaginal misoprostol

Abstract

Background: Purpose of this study was to evaluate the efficacy and safety of different routes of administration of misoprostol - 50µg oral, 25µg vaginal and 50µg sublingual for induction of labour in women with premature rupture of membranes after 34 weeks of gestation.

Methods: Women admitted to labour ward with premature rupture of membranes (PROM) after 34 weeks of gestation and requiring induction of labour were randomized into three groups. A total of 246 women participated in the study and were assigned to three groups to receive either 50µg oral misoprostol (n=80) or 25µg vaginal misoprostol(n=83) or 50µg sublingual misoprostol (n=83). The doses were repeated 4 hourly till active labour was established or up to a maximum of 4 doses. Patient factors, induction to delivery intervals, maternal side effects and fetal outcomes were noted.

Results: The mean induction to active labour interval was not significantly different in the three groups (oral vs vaginal vs sublingual-7.52±4.8 vs 7.75±4.1 h vs 7.68±5.3 h; p=0.93). There was no significant difference in the induction to delivery time interval among the three misoprostol groups (oral vs vaginal vs sublingual - 10.9± 5.9 h vs 11.2±5.0 h vs 11.4±6.6 h; p= 0.88). Spontaneous vaginal delivery rate, instrumental delivery rate and lower segment ceasarean section rates were comparable among the three groups. The number of neonates with APGAR score <7 (low APGAR) at 1 minute of birth was highest in sublingual group and lowest in vaginal group which was statistically significant (oral vs vaginal vs sublingual, 16% vs 7.2% vs 20.5%; p= 0. 04). APGAR score <7 at 5 minutes was not significantly different among the three groups (oral vs vaginal vs sublingual, 4.8% vs 2.4% vs 7.2%; p=0.2). This implies that the need for immediate resuscitation was more in the sublingual group. Neonatal intensive care admission was least in the vaginal group although the difference was not statistically significant. Sublingual group had a higher rate of hyperstimulation and fetal heart rate abnormalities compared to oral and vaginal groups although these parameters did not reach statistical significance.

Conclusions: Oral, vaginal and sublingual routes of administration of misoprostol are equally effective for labour induction in women with premature rupture of membranes after 34 weeks with sublingual route having slightly higher incidence of low APGAR scores at one minute for the neonate.

References

Gunn GC, Mishell DR Jr, Morton DG. Premature rupture of the fetal membranes. A review. Am J Obstet Gynecol. 1970 Feb 1;106(3):469-83.

Duff P. Premature rupture of the membranes in term patients. Semin Perinatol. 1996 Oct;20(5):401-8.

(2013) ACOG practice bulletin No.139: premature rupture of membranes. Obstet Gynecol 122:918–930

Horvath B, Grasselly M, Bodecs T, Boncz I, Bodis J. Histological chorioamnionitis is associated with cerebral palsy in preterm neonates. Eur J Obstet Gynecol Reprod Biol. 2012 Jun7

Tan BH, Hannah ME. Prostaglandins for prelabour rupture of membranes at or near term. Cochrane Database Syst Rev. 2000;(2):CD000178.

Cunningham FG, Leveno KJ, Bloom SL, Hauth JC, Rouse D, Spong C. Labour induction. Williams obstetrics – 23rdedition. McGraw Hill Companies, Inc. USA, 2010, P501.

Weeks A, Alfirevic Z, Faundes A, Hofmeyr GJ, Safar P, Wing D. Misoprostol for induction of labour with a live fetus. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S194-7.

Hofmeyr GJ, Gülmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour.Cochrane Database Syst Rev. 2010 Oct 6;(10):CD000941.

Alfirevic Z, Weeks A. Oral misoprostol for induction of labour.. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001338.

Shetty A, Danielian P, Templeton A. Sublingual misoprostol for the induction of labour at term. Am J Obstet Gynecol. 2002 Jan;186(1):72-6.

Elhassan EM, Nasr AM, Adam I. Sublingual compared with oral and vaginal misoprostol for labour induction. Int J Gynaecol Obstet.2007 May;97(2): 153-4.

Hall R, Duarte-Gardea M, Harlass F. Oral versus vaginal misoprostol for labour induction. Obstet Gynecol. 2002 Jun;99(6):1044-8.

Paungmora N, HerabutyaY, O-Prasertsawat P, Punyavachira P. Comparison of oral and vaginal misoprostol for induction of labour at term: a randomized controlled trial. J Obstet Gynaecol Res.2004 Oct;30(5):358-62.

Mehrotra S, Singh U, Gupta HP. A prospective double blind study using oral versus vaginal misoprostol for labour induction. J Obstet Gynaecol. 2010; 30(5):461-4.

Bartusevicius A, Barcaite E, Krikstolaitis R, Gintautas V, Nadisauskiene R. Sublingual compared with vaginal misoprostol for labour induction at term: a randomised controlled trial. BJOG. 2006 Dec;113(12):1431-7.

Zahran KM, Shahin AY, Abdellah MS, Elsayh KI. Sublingual versus vaginal misoprostol for induction of labour at term: a randomized prospective placebo-controlled study. J Obstet Gynaecol Res. 2009 Dec;35(6):1054-60.

Feitosa FE, Sampaio ZS, Alencar CA Jr, Amorim MM, Passini R Jr. Sublingual vs. vaginal misoprostol for induction of labour. Int J Gynaecol Obstet. 2006 Aug;94(2):91-5

Shetty A, Mackie L, Danielian P, Rice P, Templeton A. Sublingual compared with oral misoprostol in term labour induction: a randomised controlled trial. BJOG. 2002 Jun;109(6): 645-50.

Shetty A, Danielian.P, Templeton.A. A comparison of oral and vaginal misoprostol tablets in induction of labour at term. BJOG. 2001 Mar;108(3):238-43.

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Published

2018-03-27

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Original Research Articles