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SU SU TUN, MAY MYO KYWE, SAN SAN MYINT, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,

SUBLINGUAL VERSUS VAGINAL MISOPROSTOL FOR CERVICAL RIPENING PRIOR TO MANUAL VACUUM ASPIRATION IN FIRST TRIMESTER MISCARRIAGE. SU SU TUN, MAY MYO KYWE, SAN SAN MYINT, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, UNIVERSITY OF MEDICINE (1), YANGON, MYANMAR.

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SU SU TUN, MAY MYO KYWE, SAN SAN MYINT, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,

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  1. SUBLINGUAL VERSUS VAGINAL MISOPROSTOL FOR CERVICAL RIPENINGPRIOR TO MANUAL VACUUM ASPIRATION IN FIRST TRIMESTER MISCARRIAGE SU SU TUN, MAY MYO KYWE, SAN SAN MYINT, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, UNIVERSITY OF MEDICINE (1), YANGON, MYANMAR

  2. Introduction Miscarriage common gynaecologicalproblem worldwide 1st trimester miscarriage - Miscarriage occurring below and at 12week gestational age Treatment options - expectant, medical and surgical management Among different surgical methods, manual vacuum aspiration (MVA) is safe and convenient.

  3. Vacuum aspiration A method by which the contents of the uterus are evacuated through a plastic or metal cannula that is attached to vacuum source. • Cervical ripening is necessary prior to (MVA)- to prevent uterine perforation and cervical laceration due to forceful dilatation of cervix. • Misoprostol is a commonly used drug for cervical ripening

  4. Misoprostol • Synthetic analogue of naturally occurring PGE1 • Binds to myometrial cells to cause strong myometrial contractions leading toexpulsion of tissue. • Causes cervical ripening with softening and dilatation of the cervix. • Vaginal, oral and sublingual route are commonly used for cervical ripening

  5. WHO guideline for safe abortion recommends 400 mcg misoprostol either vaginally3-4 hours or sublingually 2-3 hours prior to the surgical procedure is effective in cervical ripening (WHO, 2012).

  6. Aim To study the effectiveness and side-effects of same dose (400 μg) of sublingual to vaginal misoprostol for cervical ripening before MVA in 1st trimester miscarriage

  7. About the study • Hospital based randomized controlled trial • Study area- B block, Central Women's Hospital, Yangon • Study period-From 1st January 2016 to 31st December 2016 (1 year) • Study Population- A total of 200 women admitted with spontaneous miscarriage, gestational age up to 12 weeks with baseline cervical dilatation <4mm

  8. Exclusion Criteria Septic abortion and induced abortion Molar pregnancies Uterine anomalies Medically or haemodynamically unstable patients Women with pelvic infection History of misoprostol allergy, anticoagulant usage, chronic illness and bleeding disorders Women with baseline cervical dilatation ≥4mm

  9. Participants Randomization Vaginal misoprostol 400mcg Sublingual misoprostol 400mcg Manage according to hospital guideline 3 hour 2 hour Assess post-medication cervical dilatation, occurrence of side-effects Assess post-medication cervical dilatation, occurrence of side-effects Cervical dilatation 7mm Cervical dilatation < 7mm Cervical dilatation < 7mm Cervical dilatation7mm Considered as success case and proceed to MVA Manage according tohospital guideline Considered as success case and proceed to MVA

  10. Main outcome measure- cervical dilatation assessed using Hagar's dilator prior to the procedure (MVA) • If cervical dilatation ≥ 7mm, the condition was considered as a success. • Secondary outcome measure - find out the side- effects of the drug such as fever, vomiting, shivering, diarrhea and abdominal pain.

  11. Instruments used in the study

  12. Data collection and data analysis • Data collection - by proforma • Data entry, data clean up, data summarization and data analysis - by computer using SPSS software version16 • Differences in continuous variables was analyzed with chi-squared test and p value was calculated. • p <0.05 was considered statistically significant.

  13. Results • No significant statistically difference in age distribution, education status , parity and gestational age among two study groups • In comparison of cervical dilatation before misoprostol between two groups, p value was 0.695 and no significant statistically difference.

  14. Cervical dilatation 2 hours after sublingual misoprostol 92% of patients achieved cervical dilatation 7mmand above within 2 hours of administration.

  15. Cervical dilatation 3 hours after vaginal misoprostol Only 45% of patients achieved cervical dilatation 7mm and above within 3hours of administration.

  16. Comparison of success rate between two different routes Among sublingual group, success rate- 92% and failure rate 8%.Among vaginalgroup,successrate -45% and failure rate -55%. There was statistically significant difference in success rate between the two groups (p<0.001).

  17. Comparison of side- effects between two different groups All patients in the study were suffered no side effect such as vomiting, abdominal pain, shivering and diarrhea.

  18. Discussion • Win WinAye(2010) showed Sublingual route of misoprostol was easier to administer and had same clinical effectiveness in cervical ripening before evacuation and curettage in 1sttrimester miscarriage • Shetty and colleagues (2015) concluded 2 hour of cervical priming with 400mcg of sublingual misoprostol before MVA was as good as 3 hours with vaginal administration of the same dose.

  19. In this study, (a) Success rate Sublingual group- Higher in success rate abundant blood supply under the tongue and tablets were absorbed with 15 minutes and so it took short time to give its action (high bioavailability, more rapid absorption, rapid action) • p < 0.001 ---- statistically significant difference in success rate between the two groups

  20. (b) Failure rate • Only 8 % in sublingual group and 55 % in vaginal group. • Vaginal route-- absorption was variable and incomplete (due to the variation between women in the amount and pH of vaginal discharge) • took longer time to take its action. • more chance of failure (because of reduced absorption of drug and reduced efficacy )

  21. (c) Time interval between the drug administration and adequate cervical dilatation • 2 hours in the sublingual group • 3 hours in the vaginal group. • Sublingualroute needed shorter time interval in hours between the administration of drugs and cervical ripening compared to vaginal group.

  22. (d )Side effects, None of the patients had side- effects of drug (low doseand only single dose and so the side-effects were not significant) In conclusion, sublingual route of misoprostol • easier to administer • more clinical effectiveness compared to vaginal misoprostol in cervical ripening prior to MVA in 1st trimester miscarriage

  23. References • Shetty J, Chawla R,.Pandey D, Kamath A, Guddattu V (2015). Sublingual misoprostol: A Better Choice for Cervical Priming before Manual Vacuum Aspiration. Indian Journal of Medical Sciences, 64(8). • Win-Win-Aye (2010). A Study on the Use of Sublingual Versus Vaginal Misoprostol for Cervical Ripening in First Trimester Miscarriage in Central Women’s Hospital. M.Med.Sc (OG) dissertation, University of Medicine 1, Yangon.

  24. World Health Organization (WHO) (2012) .Safe abortion: Technical and Policy Guidance for Health Systems. Clinical care for women undergoing abortion.Geveva, WHO; 3.3:46.

  25. Thank You

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