A Comparison of the Efficacy and Safety Profile of Sub-lingual and Vaginal Misoprostol for Induction of Labour: A Randomized Controlled Trial
Main Article Content
Abstract
Background:
To prevent adverse obstetric outcomes during pregnancy, induction of labour may become necessary. Either sublingual or vaginal misoprostol can be used however the optimal dosage and route of administration for induction of labour remain unclear in our clinical setting. This study therefore sought to compare the efficacy and safety of sublingual versus vaginal misoprostol for induction of labour in term pregnancies.
Aim:
To compare the outcome of events of labour and delivery using the sub-lingual and vaginal routes for induction of labour.
Methodology:
One hundred and forty (140) pregnant women at term who fulfilled the inclusion criteria were equally randomized into the two arms of the study to receive either 25 µg of misoprostol sublingually or 25µg vaginally and the efficacy and safety profile of the different routes were compared. Data was entered into SPSS spread sheet and analyzed using IBM SPSS version 25 (IBM SPSS Inc., Illinois, USA). A p-value < 0.05 will be considered significant statistically. Results will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Results:
The efficacy of sublingual and vaginal misoprostol for induction of labour was comparable. Though a higher proportion of women in the vaginal group achieved delivery within 24 hours compared with the sublingual group (84.3% vs. 74.3%), this difference was not statistically significant (χ² = 2.13, P = 0.14), meeting the predefined non-inferiority margin (difference = 0.14). The mode of delivery was similar between the two groups, with spontaneous vaginal delivery being the most common outcome (84.3% vs. 80.0%), followed by assisted vaginal delivery (2.8% vs. 4.3%) and Caesarean section (12.9% vs. 15.7%), with no significant difference (p = 0.84). The study found no statistically significant difference in the induction delivery interval between the sublingual misoprostol group and the vaginal misoprostol group.
Safety outcomes were also comparable across both routes. There were no statistically significant differences in the rates of antepartum haemorrhage (1.4% vs. 2.9%, p = 0.55), postpartum haemorrhage (5.7% vs. 7.1%, p = 0.73), blood loss ≥ 500 ml (5.7% vs. 7.1%, p = 0.73), or need for blood transfusion (5.7% vs. 7.1%, p = 0.73). No cases of uterine rupture occurred in either group. Cervical (5.7% vs. 11.4%) and vaginal lacerations (15.7% vs. 47.1%) were more frequent in the vaginal group but without statistical significance (p > 0.05). The study identified a statistically significant difference in the time required to reach the active phase of labour between the sublingual misoprostol group and the vaginal misoprostol group. Mean number of misoprostol doses required was significantly lower in the sublingual group. Need for augmentation was lower in the sublingual group, but this difference was not statistically significant.
Conclusion:
The sublingual and vaginal routes for administration of misoprostol at the same dose showed comparable safety and efficacy for induction of labour and delivery.
Downloads
Article Details
Section
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
All articles published in the journal are licensed under a Creative Commons Attribution (CC BY) license(i.e CC Attribution-NonCommercial-ShareAlike 4.0), allowing others to share, distribute, and build upon the work, provided the original author(s) and source are properly cited. Authors retain the copyright of their work.
How to Cite
References
Ayati S, Vahidroodsari F, Farshidi F, Shahabian M, Afzal AM. (2014). Vaginal Versus Sublingual Misoprostol for Labour Induction at Term and Post Term: a Randomized Prospective Study. Iran Journal of Pharmaceutical Research, 13(1), e125410.
Nimbark N, Joshi PM, Joshi MI. (2023). A randomized comparative study of induction of labour with sublingual misoprostol 50 μg and oral misoprostol 50 μg in term patients. International Journal of Basic and Clinical Pharmacology, 12:211–215.
Essam MS, Alaa EH, Amr AE. (2019). Randomized controlled trial comparing sublingual and vaginal misoprostol for induction of labour at term. Evidence Based Women’s Health Journal, 9(2):407–415.
Martina K, Franziska K. (2014).
Maternal and neonatal outcome of labour induction at term comparing two regimens of misoprostol. Journal of Perinatal Medicine, 42:603–609.
Guerra GV et al. (2009). Factors and outcomes associated with the induction of labour in Latin America. BJOG, 116:1762–1772.
World Health Organization (2011). WHO recommendations for induction of labour. Geneva: WHO. Available at: https://www.ncbi.nlm.nih.gov/books/NBK131965/
Martin JA et al. (2021). Births: final data for 2019. National Vital Statistics Reports, 70:1–51.
European Perinatal Health Report (2010). Paris: Euro-Peristat Project. Available at: www.europeristat.com
Ibrahim IA, Obilahi A, Ekine AA. (2012). The Safety of Induction of Labour in the Niger Delta Region. Greener Journal of Medical Sciences, 6(2):173–178.
Ekele BA, Jaiyeola AO. (2002). Induction of labour at Usman Danfodiyo University Teaching Hospital Sokoto. Tropical Journal of Obstetrics and Gynaecology, 19:74–77.
Pavlos V et al. (2023). Efficacy and safety of oral and sublingual versus vaginal misoprostol for induction of labour: systematic review and meta-analysis. Archives of Gynecology and Obstetrics, 308:727–775.
Hofmeyr GJ et al. (2011). Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database of Systematic Reviews, CD000941.
Muzonzini G, Hofmeyr GJ. (2011). Buccal or sublingual misoprostol for cervical ripening and induction of labour. Cochrane Database of Systematic Reviews, CD004221.
Gattás DS et al. (2018). Misoprostol sublingual versus vaginal for induction of labour: randomized controlled trial protocol. Reproductive Health, 15:65.
Ezebialu IU et al. (2015). Methods for assessing pre-induction cervical ripening. Cochrane Database of Systematic Reviews, CD010762.
Ugwuoroko HC et al. (2023). Obstetric outcome of induction of labour in a tertiary hospital in Nigeria. International Journal of Innovative Research in Medical Science, 8(7):235–240.
Kuba K et al. (2023). Reassessing the Bishop score in clinical practice for induction of labor. Placenta and Reproductive Medicine, 2:8.
American College of Obstetricians and Gynecologists (2009). ACOG Practice Bulletin No. 107: Induction of labour. Obstetrics & Gynecology, 114(2):386–397.
Alfirevic Z et al. (2016). Which method is best for induction of labour? Systematic review and network meta-analysis. Health Technology Assessment, 20:1–584.
Bartusevicius A et al. (2006). Sublingual compared with vaginal misoprostol for labour induction at term. British Journal of Obstetrics and Gynaecology, 113:1431–1437.
Souza AS et al. (2008). Comparison of sublingual versus vaginal misoprostol for induction of labour: systematic review. BJOG, 115:1340–1349.
Alfirevic Z et al. (2014). Oral misoprostol for induction of labour. Cochrane Database of Systematic Reviews, CD001338.
Charan J, Biswas T. (2013). How to calculate sample size for different study designs in medical research. Indian Journal of Psychological Medicine, 35:121–126.
Ifariola D et al. (2020). Randomization of vaginal and sublingual misoprostol for cervical ripening and labour induction. Tropical Journal of Obstetrics and Gynaecology, 37:78–84.
Keulen KJ et al. (2019). Induction of labour at 41 weeks versus expectant management. BMJ, 364:344.
Okonkwo RI et al. (2023). Effectiveness and safety of vaginal versus sublingual misoprostol for induction of labour. International Journal of Medical and Health Development, 28:31–38.
Poonam Y et al. (2025). Comparison of effectiveness of sublingual versus vaginal misoprostol use for labour induction. Journal of Neonatal Surgery, 14(18s):1089–1094.
Chhatani PL, Pitre D. (2024). Comparison of 25 microgram sublingual vs vaginal misoprostol for induction of labour. IJCOG, 8(1):28–32.
Kattan EI et al. (2013). Sublingual versus vaginal misoprostol for induction of labor in term primigravidas: randomized study. Evidence Based Women’s Health Journal, 3(3):111–114.