Background: To compare the efficacy of misoprostol (PG E1 analog) and Dinoprostone (PGE2) for induction of labour in patients with premature rupture of membranes (PROM).
Methods: This prospective study was conducted at the Department of Obstetrics and Gynaecology, Dr. BVP Rural medical college, Loni, Ahmednagar, Maharashtra. A total of 120 women (60 in each group) presenting with PROM (premature rupture of membranes) within 48 hours with gestational age between 34 weeks to 40 weeks were included. Group A women received tab misoprostol 25 mcg orally and Group B women received Dinoprostone gel vaginally kept in posterior vaginal fornix for induction of labour. Dose was repeated every 4th hourly in Group A with maximum of 4 doses and it was repeated 6th hourly In Group B with maximum of 3 doses.
Results: Among 60 patients in Group A, 47 (78.33%) delivered vaginally and 13 (21.66%) were delivered by caesarean section. In Group B, 39(65%) patients delivered vaginally and 21(35%) were delivered by LSCS.
Conclusions: Oral misoprostol 25 mcg 4 hourly is efficient and cost-effective alternative to PGE2 gel for cervical ripening and induction of labour in PROM patients

Bangal, V. B.

R. S., Rachana

English

International Journal of Reproduction, Contraception, Obstetrics and Gynecology

                                                                                                                                   March 2025 · Volume 14 · Issue 3    Page 765 International Journal of Reproduction, Contraception, Obstetrics and Gynecology Rachana RS et al. Int J Reprod Contracept Obstet Gynecol. 2025 Mar;14(3):765-768 www.ijrcog.org pISSN 2320-1770 | eISSN 2320-1789 Original Research Article Misoprostol versus Dinoprostone for induction of labour in premature rupture of membranes  Rachana R. S.*, V. B. Bangal               INTRODUCTION Prostaglandins are essential mediators of labor, influencing cervical remodelling and myometrial contractions.1,2 Their role in cervical ripening and labor induction is well-established, with synthetic analogs like prostaglandin E1 (Misoprostol) and Prostaglandin E2 (Dinoprostone) widely used in clinical practice.3 However, the choice between these agents remains debated, particularly in pre-labor rupture of membranes (PROM) cases, where induction strategies must balance efficacy with the risk of infection and maternal-fetal complications.4 PROM, defined as the rupture of fetal membranes before labor onset, has an incidence of 5-10%, with 60% occurring at term.2 The management of PROM is time-sensitive, as prolonged latency increases the risk of chorioamnionitis, neonatal sepsis, and adverse perinatal outcomes.5,6 The American college of obstetricians and gynaecologists (ACOG) recommends labor induction in PROM at or beyond 34 weeks to mitigate these risks.7,8 However, the optimal prostaglandin choice, particularly in resource-limited settings, requires further evaluation. Rationale for study While both PGE1 (misoprostol) and PGE2 (dinoprostone) are used for labor induction, their mechanisms of action, administration routes, storage requirements, and safety profiles differ significantly.9,10 Misoprostol (PGE1 analog) is a low-cost, heat-stable agent available in oral, sublingual, and vaginal forms, making it particularly advantageous in low-resource settings where refrigeration is not feasible.11 Dinoprostone (PGE2 gel or pessary) requires cold chain storage and carries a higher risk of DOI: https://dx.doi.org/10.18203/2320-1770.ijrcog20250501 Department of Obstetrics & Gynaecology, Dr. BVP Rural Medical College, Loni, Ahmednagar, Maharashtra, India  Received: 24 January 2025 Revised: 16 February 2025 Accepted: 17 February 2025  *Correspondence: Dr. Rachana R. S., E-mail: rachana.sridhar666@gmail.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: To compare the efficacy of misoprostol (PG E1 analog) and Dinoprostone (PGE2) for induction of labour in patients with premature rupture of membranes (PROM). Methods: This prospective study was conducted at the Department of Obstetrics and Gynaecology, Dr. BVP Rural medical college, Loni, Ahmednagar, Maharashtra. A total of 120 women (60 in each group) presenting with PROM (premature rupture of membranes) within 48 hours with gestational age between 34 weeks to 40 weeks were included. Group A women received tab misoprostol 25 mcg orally and Group B women received Dinoprostone gel vaginally kept in posterior vaginal fornix for induction of labour. Dose was repeated every 4th hourly in Group A with maximum of 4 doses and it was repeated 6th hourly In Group B with maximum of 3 doses. Results: Among 60 patients in Group A, 47 (78.33%) delivered vaginally and 13 (21.66%) were delivered by caesarean section. In Group B, 39(65%) patients delivered vaginally and 21(35%) were delivered by LSCS. Conclusions: Oral misoprostol 25 mcg 4 hourly is efficient and cost-effective alternative to PGE2 gel for cervical ripening and induction of labour in PROM patients.  Keywords: Labour, Misoprostol, Dinoprostone  Rachana RS et al. Int J Reprod Contracept Obstet Gynecol. 2025 Mar;14(3):xxx-xxx International Journal of Reproduction, Contraception, Obstetrics and Gynecology                                     Volume 14 · Issue 3    Page 766 ascending infections due to repeated vaginal examinations.12,13 Given these differences, understanding the comparative efficacy and safety profiles of these agents in PROM cases is crucial for optimizing clinical outcomes. Study objectives Primary objective To compare vaginal delivery rates in patients induced with misoprostol (PGE1) versus dinoprostone (PGE2) in PROM cases. Secondary objectives To evaluate LSCS rates and indications in both groups. To assess neonatal outcomes, including, incidence of meconium-stained liquor. Apgar scores at birth. NICU admissions. METHODS The present study is hospital based prospective study done at the Department of Obstetrics & Gynaecology, Dr. BVP Rural medical college, Loni, Ahmednagar, Maharashtra. All pregnant women with age group of 15-30 years and period of gestation between 34 to 40weeks assessed by LMP irrespective of parity, presenting with PROM within 72 hours and cephalic presentation with bishop’s less than 5 with no uterine contractions were included in the study. Exclusion criteria Non-cephalic presentation, twin pregnancy, cervix ≥3 cm dilatation, hypersensitivity to prostaglandins, history of any uterine surgery like previous LSCS, myomectomy, hysterotomy, placenta previa, grand multiparity, history of medical disorder like hypertensive disorders, asthma, heart disease, gestational diabetes, any evidence of chorioamnionitis like temperature >37.5℃, uterine tenderness, ↑TLC, Fetal distress, Meconium-stained liquor. Sample size in the present study is 120 depending on the average number of PROM cases in two-year period from December 2022-November 2024. Study period was 24 months (18 months for data collection and 6 months for data compilation) of December 2022-November 2024. All women meeting the inclusion criteria were enrolled in the study through labour ward. The purpose of the study was explained to the patients and written informed consent was obtained. A detailed history was taken regarding age, parity, and time since PROM. Obstetrical examination was done to confirm the PROM. All included patients were randomly allocated in two groups. Sampling technique was based on simple random sampling where patients receiving oral misoprostol 25 mcg drug were allocated in group A and patients receiving Dinoprostone gel vaginally were allocated in group B. Dose was repeated every 4th hourly in Group A with maximum of 4 doses and it was repeated 6th hourly In Group B with maximum of 3 doses. RESULTS 120 patients were enrolled in the study. Group A had 60 patients and group B had 60 patients. Group A were induced with 25 mcg misoprostol tablet orally and group B were induced with dinoprostone PGE2 gel. Both the groups had comparable age wise distribution as seen in Table 1. In group A 71.67% of women were belonging to the age group of 18-25 while in group B it was 65%. In group A 28.33%. Both groups had comparable number of primigravida and multigravida. There were 33 primigravida in Group A and 40 in group B and 35 multigravidas in Group A and 39 in group B (Table 1). Table 1: Age, parity, mode of delivery wise distribution.   Group A Group B Age (years) 18-25 71.67% 65% >25 28.33% 35% Parity Primigravida 55% 73.33% Multigravida 45% 26.67% Mode of delivery Vaginally 78.33% 65% LSCS 21.67% 35% Table 2: LSCS indications. LSCS indication Group A Group B Meconium-stained liquor 9 6 Failed induction 2 11 Fetal distress 2 4 13 (100%) 21 (100%) Among 60 patients in group A, 47(78.33%) delivered vaginally and 13(21.67%) were delivered by cesarean section. In group B, 39(65%) patients delivered vaginally and 21(35%) were delivered by LSCS (Table 1). The indications of LSCS were meconium-stained liquor, fetal distress and failed induction (Table 2). Among 13 patients delivered through LSCS in group A 9 patients had meconium-stained liquor, 2 patients had failure of induction and 2 patients had fetal distress. In group B out of 21 patients delivered through LSCS, 6 patients had meconium-stained liquor, 11 patients had failure of induction and 4 patients had fetal distress.  Among 60 patients in group A, 47 (78.33%) delivered vaginally and 13 (21.66%) were delivered by cesarean section. In group B, 39 (65%) patients delivered vaginally and 21 (35%) were delivered by LSCS. Among the patients delivered, 12 had meconium-stained liquor in group A out of which, 3 delivered vaginally and 9 were delivered through LSCS. 7 had meconium-stained liquor in group B, out of which 1 was delivered vaginally and 6 were delivered through LSCS. 2 patients in group A had APGAR<5, and 1 in group B had APGAR<5. These babies needed NICU admission. Rachana RS et al. Int J Reprod Contracept Obstet Gynecol. 2025 Mar;14(3):xxx-xxx International Journal of Reproduction, Contraception, Obstetrics and Gynecology                                     Volume 14 · Issue 3    Page 767   Figure 1 (A and B): Mode of delivery: vaginal and LSCS rates in group A and group B  Figure 2: LSCS indications. DISCUSSION In the present study, the synthetic PGE1 analogue, oral misoprostol, was compared with PGE2 intracervical dinoprostone gel in patients with premature rupture of membranes (PROM). The study aimed to evaluate the vaginal delivery rate, mode of delivery, incidence of meconium-stained liquor, and APGAR scores in both groups. Vaginal delivery The vaginal delivery rate was 78.33% in the misoprostol group and 65% in the dinoprostone group. These findings align with those reported by Shetty et al, who found a similar success rate for misoprostol in PROM cases.14 Additionally, Kumari et al, observed a higher vaginal delivery rate of 73.97% with misoprostol compared to 47.22% with dinoprostone, further supporting the efficacy of misoprostol in improving labor outcomes.15 Several studies have demonstrated the advantages of oral misoprostol in labor induction, particularly its longer half-life, ease of administration, and cost-effectiveness compared to dinoprostone gel. Moreover, misoprostol has been found to produce a more sustained uterotonic effect, thereby increasing the likelihood of vaginal delivery without significantly increasing maternal or neonatal complications. Caesarean section rate The caesarean section rate was 21.66% in the misoprostol group and 35% in the dinoprostone group, indicating a lower need for surgical intervention with misoprostol. These findings are consistent with the studies conducted by Patil et al and Shetty et al, which also reported a reduced caesarean rate with misoprostol use.14,16 The lower caesarean section rate in the misoprostol group may be attributed to its more effective cervical ripening and stronger uterotonic action, leading to a higher rate of spontaneous vaginal delivery. However, it is essential to consider factors such as uterine tachysystole and hyperstimulation, which have been associated with misoprostol use and may necessitate timely monitoring during labor induction. Neonatal outcome The mean APGAR score at 5 minutes was comparable between the two groups, suggesting that both misoprostol and Dinoprostone are safe for neonatal outcomes when used appropriately. The incidence of meconium-stained liquor was slightly higher in the misoprostol group, which aligns with some previous studies reporting an increased risk of fetal distress with misoprostol use. However, this difference was not statistically significant, indicating that both drugs are equally effective in ensuring fetal well-being. Additionally, neonatal NICU admissions and 78%22%GROUP AVAGINAL DELIVERY LSCS65%35%GROUP BVAGINAL DELIVERY LSCS B0481216MECONIUMSTAINEDLIQUORFAILEDINDUCTIONFETALDISTRESSGROUP A GROUP BA Rachana RS et al. Int J Reprod Contracept Obstet Gynecol. 2025 Mar;14(3):xxx-xxx International Journal of Reproduction, Contraception, Obstetrics and Gynecology                                     Volume 14 · Issue 3    Page 768 perinatal complications did not show a marked difference between the two groups, reinforcing the safety profile of oral misoprostol in labor induction. However, given the potential risks of uterine hyperstimulation, careful dose titration and fetal monitoring remain crucial to optimizing neonatal outcomes. Limitations Clinical protocol differences variations in protocols and clinician preferences may affect induction success rate. Uncontrolled confounding factors like cervical status, Bishop score might influence labour induction outcomes. Mode of administration: differences in vaginal and oral administration could influence results. CONCLUSION Induction of labour confers benefits in various maternal and fetal conditions like PROM. Misoprostol and Dinoprostone have a significant role as inducing agents. However, both drugs have their pros and cons. This study concluded that efficacy of misoprostol is more than Dinoprostone for induction of labor in terms of rate of vaginal delivery among women with prelabour rupture of membranes & preterm premature rupture of membranes. Oral misoprostol 25 mcg 4 hourly is efficient and cost-effective alternative to PGE2 gel for cervical ripening and induction of labour in PROM patients. Funding: No funding sources Conflict of interest: None declared Ethical approval: The study was approved by the Institutional Ethics Committee REFERENCES 1. Arias F. Pharmacology of oxytocin and prostaglandins. Clin Obstet Gynecol. 2000;43:455-68. 2. Kehl S, Weiss C, Dammer U. “Induction of labour: change of method and its effects,” Geburtshilfe und Frauenheilkunde, 2015;75(3):238–43. 3. Hwa J, Martin K. The Eicosanoids: Prostaglandins, Thromboxanes, Leukotrienes, & Related Compounds; Basic & Clinical Pharmacology.14th Edition-2018; Bertram Katzung; McGraw-Hill Education. 2018: 321-338. 4. Bangal VB, Giri PA, Shah BG. A comparative study of outcome of labour induction with vaginal misoprostol versus intravenous oxytocin in premature rupture of membranes beyond 36 weeks of gestation. Int J Pharm Biomed Res. 2011;2(4):233-6. 5. Laughon SK, Zhang J, Grewal J. Induction of labor in contemporary obstetric cohort. Am J Obstet Gynecol. 2012;206(6):486-9. 6. Hofmeyr GJ, Gülmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010;10:941. 7. Fowlie A. Preterm pre-labour rupture of membranes, In: Arukumaran S, Symonds IM, Fowlie A (eds): Oxford Handbook of Obstetrics and Gynaecology. 2nd edition New Delhi, Oxford University Press. 2004: 247-249. 8. Jairam VK, Sudha S. A study of premature rupture of membranes C Management and Outcome. J of Obst and Gynec of India. 2001;51(2):58-60. 9. Duff P. Premature rupture of the membranes at term. N Engl J Med. 1996;334(16):1053-4. 10. Nayot D, Penava D, Da-Silva O, Richardson BS, De-Vrijer B. Neonatal outcomes are associated with latency after preterm premature rupture of membranes. J Perinatol. 2012;32(12):970-7. 11. Azria E, Anselem O, Schmitz T, Tsatsaris V, Senat MV, Goffinet F. Comparison of perinatal outcome after pre‐viable preterm prelabour rupture of membranes in two centres with different rates of termination of pregnancy. BJOG. 2012;119(4):449-57. 12. Van der Ham DP, van der Heyden JL, Opmeer BC, Mulder AL, Moonen RM, van Beek JHJ, et al. Management of late-preterm premature rupture of membranes: the PPROMEXIL-2 trial. Am J Obstet Gynecol. 2012;207(4):276. 13. ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynaecologists. Obstet Gynecol 2010;109:1007–19. 14. Shetty A, Livingstone I, Acharya S, Rice P. A randomized comparison of oral misoprotol and vaginal prostaglanding E2 tablets in labour induction at term. BJOG. 2004;111(5):436-40. 15. Kumari A, Chauhan N, Vidyarthi A. A comparative study of the effect of induction of labour with vaginal misoprostol versus prostaglandin E2 gel on the incidence of pathological cardiotocography tracing. Int J Reprod, Contracep, Obst and Gynecol. 2020;9(6):1-7. 16. Patil P, Patil A. Misoprostol v/s Cerviprime Gel for Induction of Labour. Int J Med Res Rev. 2013;1(2):63-70.      Cite this article as: Rachana RS, Banga VB, Misoprostol versus Dinoprostone for induction of labour in premature rupture of membranes. Int J Reprod Contracept Obstet Gynecol 2025;14:765-8. 

Misoprostol versus Dinoprostone for induction of labour in premature rupture of membranes

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Misoprostol versus Dinoprostone for induction of labour in premature rupture of membranes

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International Journal of Reproduction, Contraception, Obstetrics and Gynecology