Amr Fathy, Mostafa Seleem, Y. A. Bassiouny, Ayman Taher
Amr Fathy, Mostafa Seleem, Y. A. Bassiouny, Ayman Taher
Department of Obstetrics and Gynecology, Kasr Al-Ainy Faculty of Medicine, Cairo University, Cairo, Egypt.
Volume - 16,
Issue - 5,
Year - 2023
Objective: To evaluate the efficacy of medical abortion induction when Letrozole and misoprostol are combined vs when misoprostol is used alone. Methods: It was intended for 150 women to participate in a randomized controlled experiment. They were split into two groups at random, each with 75 people. While the control group (misoprostol alone group) only got misoprostol, the case group (letrozole group) received pretreatment letrozole 12.5mg for two days. According to American College of Obstetrics and Gynecology (ACOG) recommendations based on gestational Age, misoprostol was administered to both groups in the following dosages: 800mg sublingually in a single dose during the first trimester and 400mg sublingually every 3 hours for up to 5 doses during the second trimester. Results: 137 women in all, 69 of whom received Letrozole and 68 of whom received misoprostol alone. Complete abortions were recorded in 96 instances (70.07%), 51 of which were associated with Letrozole (73.9%) and 45(66.2%) with misoprostol alone (P=0.32). However, the case and control groups had corresponding mean expulsion start times of 7.51.8 hours and 8.31.5 hours. This suggests that the case group had an ejection that began much sooner (P=0.003). Conclusion: The current study found that a combination of misoprostol with Letrozole did not lead to a significantly higher rate of complete abortion if compared with misoprostol alone among women with missed abortion up to 20 weeks gestation. It only significantly shortened the interval to the initiation of expulsion.
Cite this article:
Amr Fathy, Mostafa Seleem, Y. A. Bassiouny, Ayman Taher. The Effectiveness of using Letrozole prior Tomisoprostol Versus Misoprostol alone for Successful Induction of missed Abortion: A Randomized Controlled Trial. Research Journal of Pharmacy and Technology 2023; 16(5):2233-8. doi: 10.52711/0974-360X.2023.00367
Amr Fathy, Mostafa Seleem, Y. A. Bassiouny, Ayman Taher. The Effectiveness of using Letrozole prior Tomisoprostol Versus Misoprostol alone for Successful Induction of missed Abortion: A Randomized Controlled Trial. Research Journal of Pharmacy and Technology 2023; 16(5):2233-8. doi: 10.52711/0974-360X.2023.00367 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-5-26
1. Say L, Chou D, Gemmill A, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323-333. doi:10.1016/S2214-109X(14)70227-X
2. Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012;119(5):1030-1037. doi:10.1097/AOG.0b013e318250b13e
3. Casper RF, Mitwally MFM. Use the aromatase inhibitor letrozole for ovulation induction in women with polycystic ovarian syndrome. Clin Obstet Gynecol. 2011;54(4):685-695. doi:10.1097/GRF.0b013e3182353d0f
4. Pfister CU, Martoni A, Zamagni C, et al. Effect of Age and single versus multiple-dose pharmacokinetics of Letrozole (Femara) in breast cancer patients. Biopharm Drug Dispos. 2001;22(5):191-197. doi:10.1002/bdd.273
5. Albrecht ED, Aberdeen GW, Pepe GJ. The role of estrogen in the maintenance of primate pregnancy. Am J Obstet Gynecol. 2000;182(2):432-438. doi:10.1016/s0002-9378(00)70235-3
6. Baird DT. Mode of action of medical methods of abortion. J Am Med Womens Assoc (1972). 2000;55(3 Suppl):121-126.
7. Bartley J, Brown A, Elton R, Baird DT. Double-blind, randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation. Hum Reprod. 2001;16(10):2098-2102. doi:10.1093/humrep/16.10.2098
8. ACOG practice bulletin No. 104: antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2009;113(5):1180-1189. doi:10.1097/AOG.0b013e3181a6d011
9. Behroozi-Lak T, Derakhshan-Aydenloo S, Broom and F. Evaluation of effect of Letrozole prior to misoprostol in comparison with misoprostol alone in success rate of induced abortion. J Gynecol Obstet Hum Reprod. 2018;47(3):113-117. doi:10.1016/j.jogoh.2017.11.002
10. Roghaei M, Tehrany H, Taherian A, Koleini N. Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial. Int J Fertil Steril. 2009;4.
11. Jain JK, Dutton C, Harwood B, Meckstroth KR, Mishell DR. A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Hum Reprod. 2002;17(6):1477-1482. doi:10.1093/humrep/17.6.1477
12. Cohen MH, Johnson JR, Li N, Chen G, Pazdur R. Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer. Clin Cancer Res. 2002;8(3):665-669.
13. Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011;117(2 Pt 1):317-323. doi:10.1097/AOG.0b013e3182073fbf
14. Livshits A, Machtinger R, David LB, Spira M, Moshe-Zahav A, Seidman DS. Ibuprofen and paracetamol for pain relief during medical abortion: a double-blind randomized controlled study. Fertil Steril. 2009;91(5):1877-1880. doi:10.1016/j.fertnstert.2008.01.084
15. Pritts EA, Yuen AK, Sharma S, Genisot R, Olive DL. The use of high dose letrozole in ovulation induction and controlled ovarian hyperstimulation. ISRN Obstet Gynecol. 2011;2011:242864. doi:10.5402/2011/242864
16. Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without Letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020;151(2):214-218. doi:10.1002/ijgo.13326
17. Naghshineh E, Allame Z, Farhat F. The effectiveness of using misoprostol with and without Letrozole for successful medical abortion: A randomized placebo-controlled clinical trial. J Res Med Sci. 2015;20(6):585-589. doi:10.4103/1735-1995.165964
18. Torky HA, Marie H, ElDesouky E, et al. Letrozole vs. Placebo Pretreatment in the Medical Management of First Trimester Missed Miscarriage: a Randomized Controlled Trial. Geburtshilfe Frauenheilkd. 2018;78(1):63-69. doi:10.1055/s-0043-122499
19. IE Otuokere, FJ Amaku. Conformational analysis and excited – state properties of a highly potent and totally selective aromatase inhibitor, 4,4'-(1H-1,2,4-triazole-1-ylmethanediyl) dibenzo nitrile (Letrozole). Research Journal of Pharmacology and Pharmacodynamics. 2015; 7(4): 176-180.
20. 20.Swati B. Pokale, Ghanshayam Jadhav. Piper longum (Linn.) restores ovarian function in Letrozole induced PCOS in Rats: Comparison with Metformin and Clomiphene citrate. Research Journal of Pharmacy and Technology. 2021; 14(10):5190-6.
21. Devadasu C.H., Harika S., Mallikarjuna T., Adilakshmi G., Sreenath A., Swetha Ratna G. A Spectrophotometric Assay for the Simultaneous Analysis of Mifepristone and Misoprostol in Tablets Using Vierodt’s and Absorbance Ratio Methods. Research J. Pharm. and Tech. 5(1): Jan. 2012; Page 46-49.
22. N. Sravanthi, K. Alekhya, S. Punitha. Formulation and Process Scale up of Misoprostol Tablets. Research J. Pharm. and Tech. 4(11): Nov. 2011; Page 1673-1675.
23. Maysoon Khudair. AL-Hadrawi, Ahmed Abdul Hasan Mohsin, Kais K.AL- Hadrawai, Noor Ismael Nasser, Ali k. Metab. Study the predictable correlation between recurrent abortion with the level of proteins S, C, Age and blood groups in women in AL-Najaf governorate, Iraq. Research Journal of Pharmacy and Technology. 2022; 15(7):3200-4.
24. N. Sravanthi, K. Alekhya, S. Punitha. Formulation and Process Scale up of Misoprostol Tablets. Research J. Pharm. and Tech. 4(11): Nov. 2011; Page 1673-1675.
25. Mary Lucita (Agasa. K. S). A Study of the Socio-Demographic and Maternal Factors Affecting Spontaneous Abortion. Int. J. Adv. Nur. Management 2(3): July-Sept.,2014; Page 159-161.
26. Samrithi Yuvaraj, A. Jothi Priya, Nirisha Sriram. Effect of Non Steroidal Anti Inflammatory Drugs in Pregnancy: A Systematic Review. Research J. Pharm. and Tech. 8(6): June, 2015; Page 787-791.
27. Muhammed A. H. Aldabagh. Immune Profile in Iraqi women with Recurrent Spontaneous Abortion (RSA) Proved with Cytomegalovirus Infection (CMV). Research J. Pharm. and Tech 2018; 11(2):599-603.
28. Hussein O. Al-Dahmoshi, Mourouge S. Alwash, Sura I. Chabuck, Noor S. Al-Khafaji, Susan I. Jabuk. Antimicrobial Susceptibility Patterns of Genital Mycoplasma Infections in Pregnancy and Spontaneous Abortion. Research J. Pharm. and Tech. 2019; 12(12):6198-6202.