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Kristina Gemzell Danielsson, MD, PhD, FFSRH (RCOG)Karolinska University Hospital, Karolinska Institutetand Hong Kong University

ESC – FIAPAC sessionThe Good NewsSimplified medical abortion - increased access to safe abortion care

Disclosures of Financial Relationships

Gemzell Danielsson has received honorarium as

an advisory board member and/or invited speaker

at Merck (MSD), Bayer, Exelgyne, Actavis, Gedeon

Richter, Exeltis, and HRA-Pharma

Millenium development goals, MDG 5 Target: To reduce by three quarters, 1990 -2015, the MMRNew goals; SDGsK. G em zell Danielsson

Abortion related deaths can be prevented !!!!

§ Recognize abortion as a major contributer to maternal mortality

à Politic ians, doctors, nurses (FIGO), the Church etc.

§ Increase access to safe abortion methods and stop outdated methods-Vacuum aspiration (MVA), medical abortion, misoprostol, ”menstrual regulation”, PAC

§ Increase emergency service för abortion related complications

à Midlevel providers, doctors, MVA, drugs

§ Contraceptive councelling and contraception also for young/unmarried women

§ Information on sexual and reproductive health and rights

§ Empower women!

Development of safe and effective abortion care§ 70ies, Prostaglandin analogues discovered by Sune Bergström

and his team at KI, Awarded the Nobel Price in 1982

§ Induced uterine contractions and cervical ripening;

§ Shown to act in synergy with progesterone receptor modulatoràDeveloped to Medical abortion

§ 1986 Mife+Gemeprost Cameron, Michie, Baird

§ 1991 Mife+oral misoprostol Norman,Thong, Baird

§ 1995 Vaginal misoprostol more effective than oral El Rafaey…,Templeton

Bygdeman M, Gemzell Danielsson K, Marions L: JAMWA 55: 3: 195-6, 2000.

Bygdeman & Swahn 1985

K. G em zell Danielsson

Medical abortion is one of the safest

medical procedures, with minimal

morbidity and a negligible risk of death.

Increased access to medical

abortion can lead to a decline in maternal morbidity

and mortality

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Käl la : Soc ia ls tyre ls ens abortsta tis tik

0

10000

20000

30000

1983 1988 1993 1998 2003 2008 2014

Antal aborter

År

Abortions 1983 - 2014

< 8 v.

9-11 v.

12-17 v.

>18 v.

Impact of reducing barriers in access

K. G em zell Danielsson

Medical abortion• Highly effective, safe and acceptable method

• Can be used for all gestational lengths

• Can replace surgical abortion

• Mifepristone –

Limited availability

Approved in about 60 countries

Expensive

Misoprostol– alone highly effectiveBut priming with mifepristone increases efficacy, allows lower dose

and less side effects

2012 Update of Updated WHO guidance on safe abortion

§ Emphasizes the simplifying or streamlining of abortion care,

§ Notes a high value on research to demedicalize abortion care

§ Affirms that home use of misoprostol is a safe option for women

The Guidance suggests the evaluation of internet provision and

telemedicine, as further alternative service delivery channels of

safe abortion, as a subject for future research

K.Gemzell Danielsson

K.Gemzell Danielsson

How can we increase access to medical abortion

with the most effective regimen?

1. Home use of (mifepristone) + misoprostol2. Telemedicine3. Task - shift / - sharing

4. Simplified procedures for FU

Simplifying medical abortionà

Increasing Access to Safe Abortion Services

K.Gemzell Danielsson

Safety and acceptability established in a number of studies

§ Reasons to choose home-use of misoprostolàEasier, More private, Feels more comfortable with a heavy

bleeding at home§ Home use an option in Sweden since 2004

(approved by the Board of Health and Welfare)

§ 99 % would have preferred to take mifepristone at homeFiala et al., 2004, Kopp-Kallner et al., 2010

§ Home use safe and well accepted also among, illiterate women with no transportation in rural areas in Rajasthan, India

Iinguar et al., Lancet Global Health 2015§ Extending outpatient medical abortion services through 70 days of

gestational age.Sanhueza Smith P et al., Reod Health Matters 2015

1. Home use of misoprostol up to 63 days

§ www.womenonweb.org

§ Telemedicine service

§ Online consultation with a medical doctor

§ Medical abortion conducted by internet/ email

§ Helpdesk

2. Medical abortion at home using telemedicine

K. G em zell Danielsson

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www.womenonweb.org

K. G em zell Danielsson

• 370 women used telemedicine and self-administration of medical abortion

• 307 women gave follow-up information about the outcome of the abortion.

• 207 (67.4%) women were pregnant up to 9 weeks • 71 (23.1%) were 10, 11 or 12 weeks pregnant, and 29 (9.5%) >13 weeks

• Significant difference in surgical intervention rates after the medical abortion • 19.3% at 9 weeks, 15.5% at 11–12 weeks and 44.8% at 13 weeks

• 42.2% of women who had a surgical intervention had no symptoms of a complication.

K.Gemzell Danielsson

3. Task sharing - Medical abortion provided by physician or nurse/ midwife

§ Midlevel provision of medical abortion in Nepal – no difference in

efficacy compared with physician

Warriner I et al., Lancet 2010

§ Midlevel provision of medical abortion in Sweden – no difference

in efficacy compared with physician

à No pre-selection of patients, Randomised at booking

à Examination incl. gynecological ultrasound

à Home use of misoprostol allowed

Kopp Kallner H, Gomperts R,Johansson,M, Salomonsson E, Marions L, K Gemzell-Danielsson, BJOG 2014

Task shiftting: Medical abortion provided by physicians or midwives

§ RCT to assess the feasibility and acceptability of medical abortion

up to 63 days' gestation when used in clinical routine

§ provided by either midwife or gynecologist

§ Training prior to the study incl basic knowledge on induced abortion,

knowledge on ultrasound examination and treatment regimens,

theoretical and practical)

Kopp Kallner H, Gomperts R,Johansson,M, Salomonsson E, Marions L, K Gemzell-DBJOG. 2014 Jul 18.

Developm ent of m edical abor t ion. K. G em zell

Results

§ 1180 patients randomised (2011-2012);

597 (nurse-midwife) and 583 (MD)

§ 1075 women treated

§ 12.4% did not return for FU

(n= 54 in nurse/midwife group vs. 76 in physician group,

(p=0·038)

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Results, equivalence trial

§ Equivalence for efficacy was established.

§ There were no significant differences in safety

parameters.

§ 17 (1.8%) of patients had a vacuum aspiration:

Developm ent of m edical abor t ion. K. G em zell

Results

§ No differences were found with regard to:

àDemographic parameters

àAcceptability

à ”How well informed”

à ”Feeling safe”

àNumbers of unscheduled visits or surgical interventions

Development of medical abortion. K.Gemzell

Results - differences

§ More consultations in the midwife group,

§ Women randomised to a physician more likely to chose home

administration of misoprostol (p=0.029).

§ Midwives providers prescribed more LARC vs. MDs ( p= 0.004).

§ Time for the consultation was shorter for midwives vs. MDs (p<0.01).

§ Significantly more patients would prefer to see a nurse-midwife in case

of a future abortion

Kopp Kallner H, Gomperts R,Johansson,M, Salomonsson E,

Marions L, K Gemzell-Danielsson, BJOG 2014

Task shifting increases productivity andincreases access to health care

4. Follow up: routine vs. self assessmentRational

§ Low rate of FU after medical abortion

§ FU may lead to unnecessary interventions

§ Only reason for FU is to detect a continuing viable pregnancy

§ Failure rates (early MA) 1/1000

§ s-hCG most effective, several limitations (acceptability, costs,

logistics)

§ s-hCG shows good correlation with u-hCG

§ High sensitivity u-hCG positive in most women at 2-4 weeks FU

Follow up: routine vs. self assessment

Objectives.

§ To evaluate self-assessment using a low sensitivity u-hCG test

(DUO-test, VedaLab, France)

à at home and telephone FU

à versus routine FU in the c linic

§ in medical abortion up to 63 days' gestation

Additional questions:

§ Is the test easy to use?

§ Do women prefer one-stop treatment compared to hospital FU?

4. Home self test

Incomplete abortionor failed test à 'Call the Clinic

Complete abortion

K. G em zell Danielsson

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Follow up: routine vs. self assessment

Design.

§ Multinational, multicentre, randomized. non-inferiority trial

Inlcusion cirteria;

§ Women > or = 18 years,

§ Opting for medical abortion at 63 days of gestation and

§ Home administration of misoprostol

§ Randomized prior to treatment

Assessment of the outcomes

§ Telephone FU by nurse/midwife within 1 month to

evaluate success and satisfaction

§ All patient records reviewed at 3 months to control for

any abortion related complications

Sunde Oppegaard K, Qvigstad, E, Fiala, C, Heik inheimo, O, Benson, L, Gemzell-Danielsson K. THE LANCET 2015; 385: 698–704.

Results

§ No difference in demography

§ No difference in efficacy or safety

à the rate of complete abortion

à no need for surgical treatment or additional misoprostol

§ Efficacy; Group 1:94% and Group 2: 95%. Risk difference (95% CI) self-assessment vs standard FU -1.0 (-4.0-2.0). p 0.513

§ Rate of surgery was 4% in both groups

§ Two ongoing pregnancies in Oslo and one in Helsinki, all in the Home

group, initially undiagnosed by the patients

Results

§ 91% found the semi-quantitative urine hCG-test easy to use.

§ No difference in telephone calls or extra visits (p=0.479)

§ Significantly more women were lost to FU in the control group

(29%) vs. the intervention group (1%) (p<0.001)

§ 82% in the intervention group preferred self-assessment vs.

59% in the control group in case of a future abortion (p<0.001).

Women are able to safely have a medical abortion with home use of

misoprostol 63 days of gestation and self assessment of the

outcome of the treatment using a low sensitivity urine hCG-test.

Self assessment is resource-saving. A step in demedicalising abortion

and women prefer it

Women need to be counseled re the risk of an undiagnosed ongoing

pregnancy. Any introduction of self-assessment will need a careful

evaluation of the test as well as of user performance

Even women with low literacy can feasibly assess the outcome of an

early medical abortionSunde Oppegaard K, Qvigstad, E, Fiala, C, Heik inheimo, O, Benson, L,

Gemzell-Danielsson K. THE LANCET 2015; 385: 698–704. Kirti Iyengar, et al., Lancet Global Helath 2015

Home self-assessment Medical abortion, ”one stop clinic”Karolinska University Hospital

§ Telefon booking (self referral)

§ Visit 1 on Day 1 to midwife (healthy women) or gynecologist;

à couselling, examination,

à contraceptive provision,- Quickstart, and

àmifepristone 200 mg

àCytotec 800 mcg, to take at home 24-48 h later, pain medication

à FU at 1- 2 weeks. u-hCG (1000 IU) self test /Check Top, Exelgyn,

§ Women can chose between:

à surgical or medical abortion

à misoprostol at home or in the c linic

à FU in the c linic or self-assessement

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Increasing Access to Safe Abortion and PAC Services

From bench - to - bed- to - the hands of women

Guidelines

Uganda MOH standards and guidelines on unsafe abortion;https://files.acrobat.com/a/preview/789cb0d3-9961-4c69-910a-684accbbb0c3

• WHO Guidance on safe abortion care 2012,

• WHO Guidance on ”task shifting” 2015

• WHO MEC 2015Misoprostol in Obstetrics&Gynaecology;• www.misoprostol.org• www.figo.org

Task shifting increases productivity andincreases access to health care

K. G emzel l Dani el sson

Increased access to safe abortion. K.Gemzell

Participating centres and investigators in the DUO study:

§ Kevin Sunde Oppegaard, MD Ph D, Dept. of Gynaecology, Helse Finnmark, KlinikkHammerfest, Norway

§ Christian Fiala, MD Ph D, GynMed Clinic, Vienna, Austria§ Erik Qvigstad, Prof, MD Ph D,, University of Oslo, Dept. of Gynaecology, § Women and Children's Div ision, Ullevål University Hospital, Norway§ Oskari Heik inheimo, MD Ph D, Dept. Obstetrics and Gynaecology,§ Helsinki University Central Hospital, Finland§ Gilda Piaggio, MSc, PhD, Brazil and Divonne-les-Bains, France§ JosaphatByamugisha, MakerereUniversity, Mulago Hosp, Uganda

§ Funding; NGOG, ESC, WHO

§ Staff at SESAM and WHO centre, Karolinska University Hospital/ Karolinska Institutet§ Rebecca Gomperts, Helena Kopp Kallner, Christian Fiala, Lena Marions, Mandira

Paul, Marie Klingberg-Allv in

Acknowledgement