Efficacy and safety of isosorbide mononitrate plus misoprostol compared to misoprostol alone in the management of the first and second trimester abortion: a systematic review and meta-analysis.
Humans
Misoprostol
/ administration & dosage
Female
Pregnancy
Pregnancy Trimester, Second
Isosorbide Dinitrate
/ analogs & derivatives
Abortion, Induced
/ methods
Abortifacient Agents, Nonsteroidal
/ administration & dosage
Pregnancy Trimester, First
Drug Therapy, Combination
Administration, Intravaginal
Treatment Outcome
Abortion
Isosorbide Mononitrate
Misoprostol
Pregnancy
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
10 Jun 2024
10 Jun 2024
Historique:
received:
03
01
2024
accepted:
29
05
2024
medline:
11
6
2024
pubmed:
11
6
2024
entrez:
10
6
2024
Statut:
epublish
Résumé
However, misoprostol is often used to terminate a pregnancy, but it can also cause side effects. Isosorbide mononitrate (ISMN) can help the cervix mature by increasing the production of prostaglandin E2 and vasodilation. Considering that the results of studies in this field are contradictory, it is the purpose of this study to evaluate the efficacy and safety of vaginal ISMN plus misoprostol compared to misoprostol alone in the management of first- and second-trimester abortions. The search process was conducted for MEDLINE through the PubMed interface, Scopus, Web-of-Science, Science Direct, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform until November 10, 2023. Our assessment of bias was based on version 2 of the risk-of-bias tool (RoB2) for randomized trials and our level of evidence quality was determined by GRADE. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1. Seven randomized clinical trials were included in the systematic review and three in the meta-analysis, with mixed quality. The results of the meta-analysis revealed that in the second-trimester abortion, the inclusion of ISMN in conjunction with vaginal misoprostol results in a noteworthy reduction in the induction abortion interval, specifically by 4.21 h (95% CI: -7.45 to -0.97, P = 0.01). The addition of vaginal ISMN to misoprostol, compared to vaginal misoprostol alone, increased the odds of a completed abortion by 3.76 times. (95% CI: 1.08 to 13.15, P = 0.04). The findings of this study can offer valuable insights aimed at enhancing counseling and support for non-surgical methods of medication abortion within professional settings. Moreover, it improves the effectiveness of clinical treatment and reduces the occurrence of unnecessary surgical interventions in the abortion management protocol.
Sections du résumé
BACKGROUND
BACKGROUND
However, misoprostol is often used to terminate a pregnancy, but it can also cause side effects. Isosorbide mononitrate (ISMN) can help the cervix mature by increasing the production of prostaglandin E2 and vasodilation. Considering that the results of studies in this field are contradictory, it is the purpose of this study to evaluate the efficacy and safety of vaginal ISMN plus misoprostol compared to misoprostol alone in the management of first- and second-trimester abortions.
METHOD
METHODS
The search process was conducted for MEDLINE through the PubMed interface, Scopus, Web-of-Science, Science Direct, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform until November 10, 2023. Our assessment of bias was based on version 2 of the risk-of-bias tool (RoB2) for randomized trials and our level of evidence quality was determined by GRADE. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1.
RESULT
RESULTS
Seven randomized clinical trials were included in the systematic review and three in the meta-analysis, with mixed quality. The results of the meta-analysis revealed that in the second-trimester abortion, the inclusion of ISMN in conjunction with vaginal misoprostol results in a noteworthy reduction in the induction abortion interval, specifically by 4.21 h (95% CI: -7.45 to -0.97, P = 0.01). The addition of vaginal ISMN to misoprostol, compared to vaginal misoprostol alone, increased the odds of a completed abortion by 3.76 times. (95% CI: 1.08 to 13.15, P = 0.04).
CONCLUSION
CONCLUSIONS
The findings of this study can offer valuable insights aimed at enhancing counseling and support for non-surgical methods of medication abortion within professional settings. Moreover, it improves the effectiveness of clinical treatment and reduces the occurrence of unnecessary surgical interventions in the abortion management protocol.
Identifiants
pubmed: 38858628
doi: 10.1186/s12884-024-06614-9
pii: 10.1186/s12884-024-06614-9
doi:
Substances chimiques
Misoprostol
0E43V0BB57
isosorbide-5-mononitrate
LX1OH63030
Isosorbide Dinitrate
IA7306519N
Abortifacient Agents, Nonsteroidal
0
Types de publication
Journal Article
Systematic Review
Meta-Analysis
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
419Informations de copyright
© 2024. The Author(s).
Références
Moradinazar M, Rostami R, Armaghan N, Shakiba M, Rai A, Azizi SA, Shakiba E. Epidemiological features of spontaneous abortion in the North Africa and the Middle East from 1990 to 2019: results from the global burden of Disease Study 2019. J Family Reproductive Health. 2022;16(3):183.
Mi M, Hall H, Rupp T. Threatened Abortion. StatPearls [Internet] Treasure Island (FL): StatPearls Publishing. 2022.
Kortsmit K, Nguyen AT, Mandel MG, Clark E, Hollier LM, Rodenhizer J, Whiteman MK. Abortion surveillance—United States, 2020. MMWR Surveillance Summaries. 2022;71(10):1.
doi: 10.15585/mmwr.ss7110a1
pmcid: 9707346
Goel A, Mittal S, Taneja B, Singal N, Attri S. Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2011;283:1409–13.
doi: 10.1007/s00404-011-1881-2
pubmed: 21431329
von Hertzen H, Huong N, Piaggio G, Bayalag M, Cabezas E, Fang A, et al. Misoprostol dose and route after mifepristone for early medical abortion: a randomised controlled noninferiority trial. BJOG: Int J Obstet Gynecol. 2010;117(10):1186–96.
doi: 10.1111/j.1471-0528.2010.02636.x
Wildschut H, Both MI, Medema S, Thomee E, Wildhagen MF, Kapp N. Medical methods for mid-trimester termination of pregnancy. Cochrane Database Syst Reviews. 2011(1).
Prasad S, Kumar A, Divya A. Early termination of pregnancy by single-dose 800 µg misoprostol compared with surgical evacuation. Fertil Steril. 2009;91(1):28–31.
doi: 10.1016/j.fertnstert.2007.11.028
pubmed: 18295212
Stockheim D, Machtinger R, Wiser A, Dulitzky M, Soriano D, Goldenberg M, et al. A randomized prospective study of misoprostol or mifepristone followed by misoprostol when needed for the treatment of women with early pregnancy failure. Fertil Steril. 2006;86(4):956–60.
doi: 10.1016/j.fertnstert.2006.03.032
pubmed: 17027362
Fernlund A, Jokubkiene L, Sladkevicius P, Valentin L. Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial. Wiley Online Library; 2018.
Abdellah MS, Hussien M, AboAlhassan A. Intravaginal administration of isosorbide mononitrate and misoprostol for cervical ripening and induction of labour: a randomized controlled trial. Arch Gynecol Obstet. 2011;284:25–30.
doi: 10.1007/s00404-010-1572-4
pubmed: 20582425
Bollapragada S, MacKenzie F, Norrie J, Eddama O, Petrou S, Reid M, Norman JE. Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour–clinical trial with analyses of efficacy and acceptability. The IMOP Study. BJOG: Int J Obstet Gynecol. 2009;116(9):1185–95.
doi: 10.1111/j.1471-0528.2009.02216.x
Dave A, Mourya P, Dave A. Role of Isosorbide Mononitrate as an Agent for Cervical ripening in second-trimester abortions. J South Asian Federation Obstet Gynecol. 2021;13(5):311–5.
doi: 10.5005/jp-journals-10006-1961
Abdel Dayem HM, Ahmed TA, Mohammed AH, Elmasrawy AH. Use of Misoprostol versus Combined Misoprostol and Isosorbide Mononitrate for Cervical Ripening before Surgical evacuation of early missed abortion. Egypt J Hosp Med. 2023;90(2):2339–44.
doi: 10.21608/ejhm.2023.286007
Atalla EI. Second trimester a abortion induction with misoprostol only versus misoprostol plus isosorbide mononitrate: a randomized controlled study. Al-Azhar Int Med J. 2022;3(4):92–6.
Mousiolis A, Sindos M, Papantoniou N, Antsaklis A. Can isosorbide mononitrate be useful in second trimester termination of pregnancies? Contraception. 2013;88(1):41–4.
doi: 10.1016/j.contraception.2012.11.018
pubmed: 23290428
Saxena P, Jaiswal N, Kabra SL, Kadam VK, Saxena V. Second trimester termination of pregnancy with misoprostol alone and misoprostol with isosorbide mononitrate: a comparative study. Int J Reprod Contracept Obstet Gynecol. 2021;10(3):971–4.
doi: 10.18203/2320-1770.ijrcog20210718
Rukkayal Fathima P. Comparison of misoprostol and misoprostol with isosorbide mononotrate in second trimester termination of pregnancy. Madras Medical College, Chennai; 2016.
Ledingham M-A, Thomson AJ, Lunan CB, Greer IA, Norman JE. A comparison of isosorbide mononitrate, misoprostol and combination therapy for first trimester pre-operative cervical ripening: a randomised controlled trial. Br J Obstet Gynaecol. 2001;108(3):276–80.
Li C-fI. Ho P-c. A study of the efficacy of cervical ripening with nitric oxide donor versus placebo for cervical priming before second-trimester termination of pregnancy. Contraception. 2003;68(4):269–72.
doi: 10.1016/S0010-7824(03)00170-7
pubmed: 14572890
Hidar S, Bouddebous M, Chaïeb A, Jerbi M, Bibi M, Khaïri H. Randomized controlled trial of vaginal misoprostol versus vaginal misoprostol and isosorbide dinitrate for termination of pregnancy at 13–29 weeks. Arch Gynecol Obstet. 2005;273:157–60.
doi: 10.1007/s00404-005-0053-7
pubmed: 16041629
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Int J Surg. 2021;88:105906.
doi: 10.1016/j.ijsu.2021.105906
pubmed: 33789826
Higgins JP, Green S. Cochrane handbook for systematic reviews of interventions. 2008.
Cumpston M, Li T, Page MJ, Chandler J, Welch VA, Higgins JP, Thomas J. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev. 2019;2019(10).
Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann HJ. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–6.
doi: 10.1136/bmj.39489.470347.AD
pubmed: 18436948
pmcid: 2335261
Khalifa EA-DM, Abdellah MS, Abdelaleem MA, Saad S. Misoprostol plus Isosorbide Mononitrate versus Misoprostol for termination of anembryonic pregnancy. Archives Health Sci. 2021;5(1):1–7.
Abu-Zaid A, Khadawardi K, Al-Matary A, Alshahrani MS, Miski NT, Abuzaid M, et al. Isosorbide mononitrate versus dinoprostone for cervical ripening during labor induction: a systematic review and meta-analysis of randomized controlled trials. Reproductive Sci. 2023;30(2):380–9.
doi: 10.1007/s43032-022-00909-y
Redinger A, Nguyen H. Incomplete abortions. 2020.
Organization WH. Abortion care guideline. 2022.
Movahed MS, Barghazan SH, Askari F, Zozani MA. The economic burden of abortion and its complication treatment cares: a systematic review. J Family Reproductive Health. 2020;14(2):60.
Abuzaid M, Baradwan S, Alkhamis WH, Alshahrani MS, Khadawardi K, Miski NT, et al. Misoprostol plus Isosorbide Mononitrate versus misoprostol alone for cervical ripening during labor induction: a systematic review and meta-analysis of randomized controlled trials. J Gynecol Obstet Hum Reprod. 2022;51(1):102235.
doi: 10.1016/j.jogoh.2021.102235
pubmed: 34583026
Ghosh A, Lattey KR, Kelly AJ. Nitric oxide donors for cervical ripening and induction of labour. Cochrane Database Syst Reviews. 2016(12).