Tesfaye Hurissa (MD, Ob-Gyn)

1. Safety and effectiveness of intra-amniotic digoxin administration to induce fetal demise prior to late second trimester medical induced abortion: Experience of St Paul’s Hospital Millennium Medical College. Tesfaye Hurissa (MD, Ob-Gyn)

2. Outline • Background • Objective • Methodology • Results • Discussion and conclusion • References

3. Background • Worldwide, 35-40 abortions occurs annually among 1000 women of reproductive age. • Majority of induced abortions are performed in the first trimester (≤13 weeks). • Still, lower but significant number of induced abortions are performed in second trimester. • A 2013-2014 recent study done in Ethiopia, Amhara region has showed that as high as 19.2% of induced abortions are second trimester.

4. Background • A variety of psychosocial reason can force a woman to delay and seek abortion in later gestational age • Studies show that these reasons are complex and are linked to multiple factors

5. Background • One of the reason for inducing fetal demise is to avoid transient fetal survival following induced abortion in second trimester • World health organization recommends that fetal demise should be considered while inducing abortion beyond 20 weeks • Royal College of Obstetrics and Gynecology(RCOG) guidance on the termination of pregnancy for fetal abnormality emphasizes that a legal abortion should not result in a surviving fetus • RCOG also states that for terminations beyond 21 weeks, the method chosen should ensure that the fetus is born dead

6. Objective • To assess Safety and effectiveness of intra-amniotic digoxin administration to induce fetal demise prior to late second trimester medical induced abortion: Experience of St Paul’s Hospital Millennium Medical College.

7. Materials and methods • The study was conducted at St Paul’s Hospital Millennium Medical College (SPHMMC), Addis Ababa Ethiopia • Retrospective cross-sectional study design was employed to assess the safety and effectiveness of intraamniotic digoxin for inducing fetal demise • All charts of women who received intraamniotic digoxin during the study period were reviewed. • Descriptive data analysis is made using frequency and percentage.

8. Result • In the study period from January 2018-June 2018, forty-nine women who presented for late second trimester medical induced abortion received trans-abdominal intra-amniotic digoxin for inducing fetal demise • All forty-nine patients came for medical induced abortion at gestational age between 20 to 28 weeks with median gestational age of 23.1 weeks. • Nearly 43% of the patients gestational age was at or above the gestational age of 24 weeks

9. Result • For all patients, obstetric ultrasound was performed and documented. • In thirty-five (71.4%) patients, fetal cardiac activity was checked 48 hours after administration of digoxin. • Twelve (24.5%) patients presented earlier than the documented instruction. • Except in two patients where 0.5 mg and 0.75 mg of digoxin was provided, all other patients (47) received 1 mg of digoxin.

10. Result • For 44 patients (89.8%) there was no detected cardiac activity following intra-amniotic digoxin administration. • In five patients, fetal cardiac activity was positive following digoxin administration. • Among these, three patients were given a repeat dose with success in achieving negative cardiac activity, making the overall success rate of 95.9%.

11. Result Table 2 - Clinical characteristics of patients with positive cardiac activity following digoxin administration

12. Result • Two patients (4%) experienced vomiting following administration of digoxin. • Two others (4%) expelled the conceptus at home   • The two patients who expelled the conceptus outside the hospital were evaluated in the hospital and discharged the same day without any complications .  

13. Discussion and conclusion • SPHMMC in partnership with other universities and partner organizations is creating platforms to enhance the quality of service in all aspects of reproductive health, including the creation of an innovative reproductive health clinic  and a new In vitro fertilization center. • The hospital receives the majority of late second trimester abortion referrals from neighboring health centers and hospitals • The issue of transient fetal survival is inevitable.

14. Discussion and conclusion • As a first experience with a small number of patients in the study, we were able to demonstrate that the administration of intra-amniotic digoxin is feasible, safe and effective. • The overall complication rate is low. • Our study also demonstrated an overall success rate of 95.9% which is in line with the success rates of other studies (between 93% to 100%)

15. Discussion and conclusion • The study was conducted in an established tertiary center, where specialized services are already provided in the management of other clinical issues, thereby potentially making the more acceptable, the implementation easier and more feasible. • The number of patients in this study are small, thereby providing only initial information as it relates to safety • However, when combined with existing data in other settings, the results are reassuring.

16. Discussion and conclusion • Despite its limitation, the study is the first to see the experience of digoxin administration for the purpose of feticide in Ethiopia. • Furthermore, existing studies generally focus on pregnancies with gestational ages below 24 weeks, while in our study, 43% of the patients were at or beyond the gestational age of 24 weeks. • Additional research with larger sample sizes, alternative routes and methods to induce fetal demise, as well as patient and provider perspectives towards these procedures are needed.

17. References 1.Sedgh G, Bearak J, Singh S, Bankole A, Popinchalk A, Ganatra B, et al. Abortion incidence between 1990 and 2014: global, regional, and subregional levels and trends. The Lancet. 2016;388(10041):258-67. 2. La Vecchia C. Recent trends in induced abortions: a global perspective. Epidemiology, Biostatistics and Public Health. 2018;15(2). 3. Boland R. Second trimester abortion laws globally: actuality, trends and recommendations. Reproductive Health Matters. 2010;18(36):67-89. 4. Mulat A, Bayu H, Mellie H, Alemu A. Induced second trimester abortion and associated factors in amhara region referral hospitals. BioMed research international. 2015;2015. 5. Harries J, Orner P, Gabriel M, Mitchell E. Delays in seeking an abortion until the second trimester: a qualitative study in South Africa. Reproductive Health. 2007;4(1):7. 6. Evans MI, Ciorica D, Britt DW, Fletcher JC. Update on selective reduction. Prenatal Diagnosis. 2005;25(9):807-13. 7. Safe abortion: technical and policy guidance for health systems, second edition. Geneva: World Health Organization; . 2012. 8. Report of the RCOG Ethics Committee on a Consideration of the Law and Ethics in Relation to Late Termination of Pregnancy for Fetal Abnormality. London: RCOG, 1998. 1998. 9.Drey EA, Thomas LJ, Benowitz NL, Goldschlager N, Darney PD. Safety of intra-amniotic digoxin administration before late second-trimester abortion by dilation and evacuation. American Journal of Obstetrics and Gynecology. 2000;182(5):1063-6.

18. Thank you