Medicinsk abort utveckling, metod och handläggning...Non-linear pharmacokinetics. Low side effects...
Transcript of Medicinsk abort utveckling, metod och handläggning...Non-linear pharmacokinetics. Low side effects...
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Kristina Gemzell Danielsson, MD, PhD, FFSRH (RCOG) Karolinska University Hospital, Karolinska Institutet and Hong Kong University
Medicinsk abort – utveckling, metod och handläggning
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K.Gemzell Danielsson
Abortion related deaths can be prevented !!!!
§ Recognize abortion as a major contributer to maternal mortality
à Politicians, 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§ Increase access to safe abortion methods and stop outdated methods- Vacuum aspiration (MVA), medical abortion, misoprostol, ”menstrual regulation”, PAC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!
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K.Gemzell Danielsson
Effektiva preventivmedel och säkra abortmetoder är
en förutsättning för Reproduktiv Hälsa
Sexual and reproductive health and rights constitute fundamental human rights, form a vital aspect of the women´s empowerment
and are a key to the achievment of gender equality
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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 modulator àDeveloped to Medical abortion
Bygdeman M, Gemzell Danielsson K, Marions L: JAMWA 55: 3: 195-6, 2000.
Bygdeman & Swahn 1985
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Leads to the regression of the corpus luteum
Gestational sac
Blocks the receptors of progesterone
The endometrium and the gestational sac separates from the uterine wall
The uterine muscle becomes more sensitive to prostaglandin and contracts
The cervix opens
Mode of action of mifepristone
Decreases ß-HCG
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Medicinsk abort
§ Optimal mifepristone dos
§ Optimal prostaglandin- typ, dos, administrationsväg
§ Graviditetslängd versus effektivitet
§ Acceptans
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Medical abortion Mifepristone
§ Mifepristone - alone is not effective (60-80%)
§ Mifepristone primes the cervix, increases contractility and
increases the sensitivity of the myometrium to PG
§ Non-linear pharmacokinetics. Low side effects
§ Provided the dose is enough for priming of the cervix and
the myometrium –increasing the dose doesn't increase
efficacy and cannot compensate for an insufficient
prostaglandin analogue/ dose/ route
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Medicinsk abort 600 mg mifepristoneà 200 mg
1988 Frankrike 49d., 0.4 mg misoprostol
1991 UK 63d.,1mg gemeprost
(1992 Kina (25mg tabl) 49d., 0.6mg miso)
1992 Sverige 63d.,1mg gemeprost, 1994 II trimester
2000 USA 49d., 0.4 mg misoprostol
2009 EMA 63d. 200mg mifepristone, 1mg gemeprost
2012 EMA 63d. 200mg mifepristone, 0.8 mg misoprostol pv.
(Medabon)
2016, USA 70d, 200mg mifepristone, 0.8 mg misoprostol bc
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What is Misoprostol?
§ An orally active prostaglandin analogue
§ Several advantages over other prostaglandin analogues (safe, less side effects, stable at room temperature, flexible administration, cheaper)
§ Marketed in 1985
§ Potential to reduce maternal mortality
§ Correct dosage and administration is vital for success and to prevent complications.
§ WHO essential medicine list; 5 indications
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Medical abortion Misoprostol § Misoprostol– alone highly effective
§ Side effects mild and dose dependent
§ Priming with mifepristone increases efficacy, allows lower dose and less side effects
§ Route of administration more important than the dose
§ Oral misoprostol not effective beyond 49-56 days. Cannot be compensated for by: à increased dose of mifepristone
à increased dose of oral misoprostol
à repeat doses of oral misoprostol
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Why is the route of administration important?
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Zieman et al. 1997
Misoprostol, farmakokinetik
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Effekt av misoprostol på uteruskontraktilitet
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Misoprostol for use in OB/Gyn Uterine contractility - different routes of administration Aronsson A et al.,Hum Reprod. 2004 Jan;19(1):81-4.
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Sublingual vs. vaginal and oral misoprostol
Sublingual administration- Pharmacokinetics:
• Tablets solved after 10-20 minutes
• Tmax similar to oral administration
• Cmax higher than oral
• Bioavailability (AUC) highest serum levels higher than
for vaginal misoprostol at 6h
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Misoprostol use in OB/Gyn Guidelines developed in collaboration with FIGO and WHO
§ Medical uterine evacuation after miscarriage or intrauterine fetal
death
§ Labour induction
§ Postpartum haemorrhage,
§ Prevention,
§ Treatment
§ Induced abortion
§ Cervical ripening for gynaecological procedures (non-essential)
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Medical abortion Recommended regimen up to 63 days
Recommended by WHO, RCOG, FARG:
mifepristone 200 mg +
misoprostol 800 mcg vaginally or sublingually
(+ 400 mcg p.o/ sl vb.)
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Repeat doses of misoprostol § 200 mg mifepristone + 800 mcg misoprostol vaginally
§ Up to 63 days of gestation
§ 2.000 consecutive abortions
§ 98% efficacy Ashok et al.,Hum Reprod 1998
§ Following 2.000 cases treated with an additional dose of 400 mcg
misoprostol if no bleeding in 4h
§ Increased efficacy, influence of pregnancy length disappeared Ashok et al., 2002
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Interval mifepristone-misoprostol
200mg mifepristone + 800 mcg misoprostol vaginally:
24h as effective as a 48h interval up to 63 days of gestation
WHO 2007
à Ökad flexibilitet; 24 to 72 timmars intervall möjligt till vecka 9
à Därefter 36-48 timmar mellan mifepriston och misoprostol
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Acceptans
Medicinsk vs. kirurgisk abort, eget val: § Medicinsk abort, 95 %
à Ej anestesi/ kirurgi
à Mer ”naturlig” metod
à Kan göras tidigt
§ Kirurgisk abort, 90 % à ”Unconcious”
à Snabbt UK Multicentre Study 1997
§ 60-80% väljer medicinsk abort FPP 1995, review 12 studies
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Kontraindikationer
§ Överkänslighet mot misoprostol/ mifepriston
§ Porfyri
§ Ektopisk graviditet
Försiktighet;
§ Koagulationsrubbning
• Kronisk binjurebarkssvikt eller långtidsbehandling med kortikosteroider
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Jämförelse medicinsk och kirurgisk abort (63d)
Behandlingsresultat Medicinsk abort (%) Kirurgisk abort (%)
Komplett abort 96-99 98
Riklig blödning 0.1-0.3 1.1
Infektion 0.03 0.9
Mekanisk skada - 0.2
Ulmann et al., acta obstet Scand 71:278, 1992, Friedman et al., Am J Pub Health 76:550, 1980 RCOG 2004
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Medicinsk abort
§ Ca. 49% aborterar inom 4h efter misoprostol
§ 75% inom 24h
§ 3-5 % aborterar efter mifepriston
§ Ca. 0.5% fortsatt graviditet
§ Blödningsmängd median 75.5 ml
§ Blödning duration medel 14d vs. 9d VA Davis 2000
§ < 0.1 % blodtransfusion
§ <1/500 - 1000 akut åtgärd inom 4h efter Cytotec
§ Akut stor blödning kan inträffa senare
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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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Symptoms indicating possible complication (incomplete abortion) that might need a surgical intervention: - Fever - Heavy bleeding (soaking more than 2 max pads per hour during more than 2 hours) - Severe lasting pain - No bleeding at all (ongoing pregnancy in <0.5% of cases) Surgical intervention is not needed if: -sonogram shows there are no ongoing pregnancy -there are no complaints as indicated above
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Safety
§ 1987-1998 ca. 405 000 medicinska aborter
§ cont. pregnancy: 71
§ 8 malformations Lancet 1998
§ Mifepristone anses ej teratogent
§ Misoprostol-oklart, Möbios syndrom
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Medical abortion
• Highly effective, safe and acceptable method
• Can be used for all gestational lengths
• Can replace surgical abortion
• Mifepristone –
Limited approval
Approved in about 60 countries
Expensive Misoprostol– alone highly effective But priming with mifepristone increases efficacy, allows lower dose
and less side effects
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How can we increase access to medical abortion
with the most effective regimen?
1. Home use of (mifepristone) + misoprostol 2. Telemedicine 3. Task - shift / - sharing 4. Simplified procedures for FU
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Safety and acceptability established in a number of studies
§ Reasons to choose home-use of misoprostol à Easier, More private, Feels more comfortable 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 home Fiala et al., 2004, Kopp-Kallner et al., 2010
§ Extending outpatient medical abortion services through 70 days of gestational age.
1. Home use of misoprostol up to 63 days
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§ www.womenonweb.org
§ Telemedicine service (English, Spanish, Portugese, French, Polish, mfl)
§ Online consultation with a medical doctor
§ Medical abortion conducted by internet/ email �
2. Medical abortion at home using telemedicine
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www.womenonweb.org
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3. Task sharing - Medical abortion provided by physician or midwife
Equally safe and effective. Well accepted.
§ Midlevel provision of medical abortion in Nepal – no difference
in efficacy compared with physician
Warriner I et al., Lancet 2010
Main differences:
§ No pre-selection of patients, Randomised at booking
§ Examination incl. gynecological ultrasound
§ Home use of misoprostol allowed Kopp Kallner H, et al., BJOG 2014
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Efterkontroll
• Low rate of follow up (FU) after medical abortion
• Only reason for FU to detect an ongoing viable pregnancy
• s-hCG most effective but limitations, good correlation with u-hCG
• Ultrasound, reliable in most cases when the yolk sac or CRL can
be visualised before treatment.
Not reliable in very early pregnancy,
Endometrium is thick in many patients at FU
• Verify expelled material
• Women’s perception-low sensitivity
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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
Self assessment safe and effective also among rural and illiterate women
No negative impact on contraceptive uptake Sunde Oppegaard K, Qvigstad, E, Fiala, C, Heikinheimo, O, Benson, L, Gemzell-
Danielsson K. THE LANCET 2015; 385: 698–704. Iyengar K, Paul M, Iyengar S, Klingberg Allvin M, Essén B, Bring J, Soni S,
Gemzell- Danielsson K, Lancet Glob Health. 2015 Sep
Home self-assessment
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Simplifying medical abortion can help to increase access to safe abortion services through:
§ Even women with low literacy can feasibly assess the outcome of an early medical abortion using the DuoTest (VedaLab, Paris France)
§ New LSUP available in Europe (checkToP, Exelgyn, Paris, France)
§ Cost:
à DuoTest 1.05 Euro/test
à checkToP approx 5 Euro/test
Hemtest
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VEMA - very early medical abortion
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Källa: Socialstyrelsens abortstatistik
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
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Skillnader i när man påbörjar aborten: § Alt 1 Påbörja aborten endast om en IUP (intrauterine pregnancy) kan
konfirmeras med ultraljud § Alt 2 Påbörja aborten utan dröjsmål även om IUP ej kan bekräftas
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Handläggningen av mycket tidiga aborter
Även skillnader i: - Uppföljning - Vad man anser vara en konfirmerad IUP
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§ Förslag på rubrik och text?
Barnhart et al, 2012
Confirmed Intrauterine Pregnancy (IUP)
Gestationssäck innehållande: 1) Gulesäck och/eller 2) Fosterstruktur med eller utan hjärtaktivitet
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Not confirmed IUP - Ingen gestationssäck, (PUL) - Intrauterin ekogivande, säckliknande struktur (Probable IUP)
• Oavsett lokalisation – excentrisk • Oavsett utseende – dubbel decidualring
§ t
Barnhart et al, 2012
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• Begränsade data om VEMA (very early medical abortion) - Är det effektivt? Sämre effekt jmf med confirmed IUP?
• Rädsla för ektopisk graviditet - Är det säkert? • Negativa konsekvenser: upprepade us/s-hcg/ulj, kostnad, minskat
förtroende osv..
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Abortsökande kvinnor i tidig graviditet utan konfirmerad IUP tvingas ofta vänta och nekas rätt till omedelbar abort
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- psykologiska - medicinska:
àmindre blödning àmindre smärta
-potentiell möjlighet att upptäcka och behandla ektopisk graviditet i tidig gestation.
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Tidig abort - fördelar
(Who. Safe abortion, 2012) (Rodger MW et al. Contraception 1989)
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VEMA. Bizjak et al., BJOG 2017
§ VEMA då ingen säkerställd intrauterin graviditet diagnositicerats är lika säkert och effektivt som medicinsk abort vid IUP
§ VEMA ledde till färre interventioner för inkomplett abort jämfört med medicinsk abort vid en säkerställd IUP
§ Kvinnor som söker tidigt innan IUP kan säkerställas bör erbjudas VEMA
§ Risken för extrauteringraviditet ska beaktas
§ VEMA kan potentiellt leda till tidigare diagnos och behandling av
extrauterin graviditet
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§ Rekommenderad handläggning är då möjlig:
à * kontrollera graviditetstest à * Informera noggrant (vilka symptom patienten bör söka akut för) à * Ta S-hCG på mifepristone-dagen före intag av tabletten à * Kontrollera S-hCG efter 1 vecka à * Om konc.fall >80% ingen ytterligare kontroll, annars snar
gynekologisk-undersökning
§ Vid symtom/riskfaktorer för X, missfall eller mola eller om ultraljudsbilden och SM inte överensstämmer àutred patologisk graviditet
§ Om första s-hCG-värdet > 5000 diskutera med spec.läk. Om risken för X fortsatt bedöms som låg kontrolleras S-hCG efter 1v enl ovan. Om fallet omvärderas till hög risk för X handläggs fallet enl PM extrauterin graviditet.
Handläggning av VEMA
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Medicinsk abort från v 9+1
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Medical abortion 9 -13 weeks § 200 mg Mifepristone
§ Vaginal misoprostol 800 mcg after 36-48 h (sublingual)
§ Misoprostol repeated if required (up to 4 doses)
§ Results: à 95.8% complete abortions within 24 hours
à 70% analgesia
à Median Induction-to-abortion interval 4.4 h
§ Partial randomised study vs. Surgical abortion; à Side effects more common with medical abortion but
à no difference in major complications Ashok et al. 1998, 2002,Hamoda et al., 2005
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Medical abortion 9 -13 weeks
§ Handlägg som II-trimester medicinsk abort dvs upprepade misoprostol doser, aktiv handläggning
§ Överväg kirurgi vid utdraget förlopp
§ Telemedicin – risk för komplikationer ingen skillnad före och efter v9+0
§ Hembehanlding med misorpostol godkänt av FDA till v10+0
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Medicinsk abort från v 12+1
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Complications following induced abortion
Secondtrimesterabortionconstitute
10-15%ofallinducedabortionsbutareresponsiblefor
twothirdsofallmajorcomplications.
WHO1997
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II-trimester abort, statistik
Från vecka 12+1 (14+)
2016: 5.4% 12+1 - 18+0 1.0% 18+1 -
Indikation; fetal 70%, social 30%
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Abort v 21+0 -21+6 under 2015
Totalt beviljades142 aborter
- 83 (59%) fosterskada - 50 (35%) sociala skäl - 9 (6%) maternell sjukdom
Antal beviljade aborter under v 21
- 21+0 - 21+2: 74 - 21+3 - 21+4: 37 - 21+5 – 21+6: 31
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Metoder
Medicinsk Icke-invasiv metod Skonsam för kvinna MEN även för fostret Minst risker för allvarliga komplikationer
Kirurgisk: Vacuumaspiration upp till v 12 (14-15), Dilatation och evakuering därefter Kräver erfarenhet, och tillgång till avancerad sjukvård vid komplikationer Fostret avlider i samband med aborten
Utdaterade eller desperata metoder: Sectio parva, galgar, generellt våld, traditionella örter, fosfor, m fl
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StandardmethodofII-trimesterinducedabortion
§ D&EstandardmethodofII-trimestersurgicalabortioninmanypartsoftheworld.
§ IntheUS,2000,D&Ewasusedfor99%ofabortions13-15weeks,94.6%;16-20weeks,and85%at21weeksorlater(Elam-Evansetal.,2003).
§ MedicalabortionstandardmethodinScandinaviaandincreasinglycommoninEurope
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Inducedsecondtrimesterabortionsugicalvsmedicalabortion
• Cervical injury is more frequent with D&E in the second trimester, preoperative cervical priming reduces the complications • Specialized training and the maintenance of an adequate caseload are required to perform D&E safely.
• “The appropriateness of D&E as a method of terminating
second-trimester pregnancy is questionable when safe and
effective medical alternatives exist” Report of Confidential Enquires into Maternal Deaths (UK 1994–1996);
Schulz et al., 1983 ; Grimes et al., 1984
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LateMedicalabortionRecommendedregimen,RCOG,FARG
Mifepristone200mgfollowedafter36to48hby
Misoprostol800mcgvaginally*+400mcgpo/3htomax4doses
§ 97%efficacy
§ mediandoseofmisoprostol:1200µg
§ medianinduction-to-abortioninterval:5.2-6.5h.
§ <10%curettage
§ >75%daycasesAshok&Templeton1999,2004,Hamodaetal.,2005
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II to III-trimester abortion >24 weeks Mifepristone 200 mg after 36-48 h followed by misoprostol
• > 24 weeks: 200 mcg p.v. followed by 200 mcg p.o/ 3h up to x 4
• > 34 weeks: 100 mcg p.v. followed by 100 mcg p.o/ 3h up to x 4
§ N= 96, 1993-1999, IUFD 24-41.3 weeks
§ mean induction-to-delivery interval 8.5 h, shorter with increasing gestation,
§ 7.2% manual removal of placenta Hamoda et al, 2002
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Pain prophylaxis
§ Premedicinering med NSAID (T Ibuprofen 600mg) i samband med
att misoprostol ges
§ Vid meab/ II-trim ges NSAID (T Ibuprofen 600 mg) + tablett /supp
paracetamol i samband med att misoprostol ges
§ Vid behov av tilläggsmedicinering ges + opioid (t.ex. t Oxycontin, t
morfin)
§ NSAID does not affect uterine contractility, cervical ripening or the
induction-to-abortion interval Li et al., Norman et al., Fiala et al., 2005
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II- and III- trimester abortion § Caution should be shown in case of previous
c-section. Few available studies
§ Women with a prior delivery have a shorter and less painful abortion while
§ younger age, more advanced pregnancy and repeated misoprostol is correlated to increased need for analgesics
Gemzell & Östlund 2002, Ashok & Templeton 1999, 2004
Hamoda et al., 2005
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Medicinsk II-trimester abort
• Starta tidigt!
• Medeltid till utstötning 5-7 timmar
• 97% aborterar inom 5 doser misoprostol dvs inom 15 timmar
• Avvakta placenta om kvinnan inte blöder, och undersök i gynstol innan beslut om operation!
• Behov av kirurgisk intervention: 2-15%
Hum Reprod. 2005 Aug;20(8):2348-54. Epub 2005 May 5. A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation. Hamoda H, Ashok PW, Flett GM, Templeton A.
Contraception. 2004 Jan;69(1):51-8. Midtrimester medical termination of pregnancy: a review of 1002 consecutive cases. Ashok PW1, Templeton A, Wagaarachchi PT, Flett GM.
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Medicinsk II-trimester abort forts..
Vad gör man med de som inte har aborterat efter 5 doser misoprostol??
• Undersök, amniotomera om möjligt • Ge ny dos mifepristone, sov på saken. Låt patienten sova!
• Dag 2 – Misoprostol behandling som på dag 1 Nu har 99% aborterat • Om inte – undersök, amniotomera om möjligt, och ge ny dos
mifepristone. Sov.
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Medicinsk II-trimester abort forts….. Dag 3 ”Active management” : • Mekanisk cx dilatation • Amniotomi • Fortsätt med misoprostol som dag 1 och 2. • Överväg oxytocin om moget cx status men kontraktioner saknas, men
absolut inte på omoget cervixstatus! Nu har 99.8% aborterat Cervix är nu mycket väl ”primad” dvs medicinskt dilaterad, och evakuering av fostret och graviditetsrester kan ske på operation. Ytterligare kirurgisk dilatation är inte alltid nödvändig men om så är fallet brukar det vara lätt att dilatera mot minimalt motstånd. Fostret kan ofta extraheras digitalt, om inte ska största möjliga tång användas.
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Medicinsk II-trimester abort <1% allvarliga komplikationer (stora blödningar, blodtransfusion, oväntad kirurgi)
Risk för uterusruptur: • 0.04% • 0.28% hos kvinnor med tidigare sectio (varav de flesta kvinnor genomgått 1
sectio!)
Obstet Gynecol. 2009 May;113(5):1117-23. doi: 10.1097/AOG.0b013e31819dbfe2. Uterine rupture in second-trimester misoprostol-induced abortion after cesarean delivery: a systematic review. Goyal V1 www.misoprostol.org
Rekommendation: • Samma dos (enl pm) kan normalt användas
upp till v 24, men; • Överväg lägre dos misoprostol hos kvinnor
med flera tidigare sectio(uteruskirurgi), och lägre dos vid avancerad gestationslängd!
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II- trimester abort, omhändertagande
• Den abortsökande kvinnan ska aldrig behöva möta personal som ifrågasätter hennes beslut gällande abort Gäller hela vårdkedjan!
• Viktigt med empatiskt bemötande och god smärtlindring efter behov och önskemål
• Kvinnan ska vara välinformerad om hur aborten går till och hur stort fostret är och att det kan ha reflexmässiga rörelser och sk gasping. Vissa kvinnor har önskemål om att få se eller ha fostret hos sig
• Fostret ska behandlas med respekt och värdighet, sk ”comfort care”
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Medicinsk abort, arbetsmiljö
• Personal som bistår kvinnor vid abort ska få god utbildning och handledning av erfarna kollegor
• Seniora specialister inom gyn/obst måste stötta sköterskor, barnmorskor och yngre kollegor – oavsett tid på dygnet
• All personal inklusive yngre läkare ska förberedas på uppgiften och veta vem som ska tillkallas vid behov – alltid gynekolog, aldrig neonatolog
• Kliniken ansvarar för att kvinnan får sin abortbehandling under värdiga former och att hennes beslut respekteras
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Feticid? Vid abort syftar alla insatser till att ge den behandling som är bäst för kvinnan Eftersom livsdugliga foster ej får aborteras har feticid ingen betydelse för utgången Feticid är ett onödigt invasivt ingrepp på kvinnan!
I speciella fall med kvinnans bästa i beaktande?
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Vad gäller vid Medicinsk abort
Läkare medicinsk ansvarig;
(ordination av läkemedel, efterkontroll)
Delegation ej tillåten men arbetet kan ”omfördelas” till barnmorska
Vch ansvarar för att fastställa rutiner
”Aborten ska utföras på sjukhus” – juridisk definition (ej =
medicinsk) aborten = mifepriston intag
BM handlägger konfirmerad intrauterin graviditet och medicinska
aborter upp till v 9+0
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1. medical termination of developing intra-uterine pregnancy
2. softening and dilatation of the cervix uteri
3. preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons
4. labour induction in fetal death in utero
Mifepristone approved indications in Europe
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Guidelines developed by the WHO
• WHO Guidance on safe abortion care 2012,
• WHO Guidance on ”task shifting” 2015
• WHO MEC 2015
Misoprostol in Obstetrics&Gynaecology; • www.misoprostol.org
• www.figo.org
Task shifting increases productivity and
increases access to health care
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