Outpatient Cervical Ripening With Misoprostol to Prevent Post-Term Pregnancy: A Double-Blind Randomized Clinical Trial
Abstract
Outpatient use of misoprostol is assessed in a few studies and usually in low doses and vaginal routes. This study aimed to evaluate cervical ripening by outpatient administration of misoprostol to prevent post-term pregnancy. This randomized clinical trial study was performed on 140 patients that were randomly allocated into two groups: 25 μg sublingual SL (group A) and 50 μg PO misoprostol (group B). The patients were primigravid with a gestational age of 40 weeks, with an amniotic fluid index (AFI) of ≥5 cm, a reactive non-stress test (NST) with no evident uterine contraction, Bishop Score of <8, and no notable past medical history. Patients who had a normal vaginal delivery before 41 weeks were considered successful delivery. Maternal age, the number of misoprostol doses, vaginal examination, type of interventions before delivery, the indication of hospitalization, delivery route, the indication of cesarean section, delivery complications, and neonatal outcomes were compared using SPSS software. P<0.05 was considered statistically significant. group A had mean age of 23.27±4.03 years and Group B had a mean age of 24.61±5.46 years with no significant difference (P=0.223). The number of misoprostol doses (P=0.001), extra misoprostol, and oxytocin application were significantly lower in group B (P=0.003). Maternal and neonatal complications showed no significant difference between the two groups (P>0.05). Outpatient cervical ripening with misoprostol appears to be an optimal method. More prospective studies with higher sample sizes are required to ensure its safety for routine recommendations for cervical ripening to prevent post-term pregnancy.
2. Maoz O, Wainstock T, Sheiner E, Walfisch A. Immediate perinatal outcomes of postterm deliveries. J Matern Fetal Neonatal Med 2019;32:1847-52.
3. Sel G. Preterm and Postterm Pregnancies. In: Sel G, ed. Practical Guide to Oral Exams in Obstetrics and Gynecology. Cham: Springer, 2020:107-19.
4. Akuamoah-Boateng J, Spencer R. Woman-centered care: Women's experiences and perceptions of induction of labor for uncomplicated post-term pregnancy: A systematic review of qualitative evidence. Midwifery 2018;67:46-56.
5. Joseph K. The natural history of pregnancy: diseases of early and late gestation. BJOG 2011;118:1617-29.
6. Jahdi F, Kalati M, Kashanian M, Naseri M, Haghani H. Effect of oral evening primrose capsules on ripening of the cervix in nulliparous iranian pregnant women (a randomized trial). Acta Med Mediterr 2016;32:1273-9.
7. Ivars J, Garabedian C, Devos P, Therby D, Carlier S, Deruelle P, et al. Simplified Bishop score including parity predicts successful induction of labor. Eur J Obstet Gynecol Reprod Biol 2016;203:309-14.
8. Solone M, Shaw KA. Induction of labor with an unfavorable cervix. Curr Opin Obstet Gynecol 2020;32:107-12.
9. Dhakal K, Rai SD. A Comparative study of Extra-Amniotic Saline Infusion (EASI), Foley’s Catheter and Prostaglandin E2 (PGE2) gel for Pre-Induction Cervical Ripening. J Karnali Acad Health Sci 2018;1:28-32.
10. PonMalar J, Benjamin SJ, Abraham A, Rathore S, Jeyaseelan V, Mathews JE. Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour. Arch Gynecol Obstet 2017;295:33-8.
11. Bartusevicius A, Barcaite E, Nadisauskiene R. Oral, vaginal and sublingual misoprostol for induction of labor. Int J Gynaecol Obstet 2005;91:2-9.
12. Wolf SB, Sanchez-Ramos L, Kaunitz AM. Sublingual misoprostol for labor induction: a randomized clinical trial. Obstet Gynecol 2005;105:365-71.
13. Marwah S, Gupta S, Batra NP, Bhasin V, Sarna V, Kaur N. A comparative study to evaluate the efficacy of vaginal vs oral prostaglandin E1 analogue (Misoprostol) in management of first trimester missed abortion. J Clin Diagn Res 2016;10:QC14-8.
14. Ten Eikelder ML, Rengerink KO, 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;387:1619-28.
15. Bishnoi S, Bishnoi R, Bora S. To Evaluate the Maternal & Fetal Complications and Outcomes in Post-Term Pregnancy: An Institutional Based Study. J Med Sci Clinic Res 2018;6:650-5.
16. Oboro VO, Tabowei TO. Outpatient misoprostol cervical ripening without subsequent induction of labor to prevent post-term pregnancy. Acta Obstet Gynecol Scand 2005;84:628-31.
17. Adeniji A, Akinola E. A comparison of orally administered misoprostol and membrane sweeping for labour induction in uncomplicated singleton post-term pregnancies. S Afr J Obstet Gynaecol 2013;19:4-7.
Files | ||
Issue | Vol 61 No 5 (2023) | |
Section | Original Article(s) | |
DOI | https://doi.org/10.18502/acta.v61i5.13481 | |
Keywords | ||
Outpatient Cervical ripening Misoprostol Post-term pregnancy |
Rights and permissions | |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |