ii-trimester abortion with mifepristone kristina gemzell danielsson, dept of obst. & gyn...

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II-trimester abortion II-trimester abortion with Mifepristone with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden FIAPAC, Moscow, October 2005

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Page 1: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-trimester abortion with II-trimester abortion with MifepristoneMifepristone

Kristina Gemzell Danielsson,

Dept of Obst. & Gyn

Karolinska University Hospital / Institute,

Stockholm, Sweden

FIAPAC, Moscow, October 2005

Page 2: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Legal abortion in Sweden

• Since 1975 ”free abortion” until 18 weeks

• Thereafter only with permission from the

National Board of Health and Welfare on

special indications until 22 weeks

• About 30 000 abortions, 90 000 births/ year

Page 3: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

The Swedish abortion act

• Has a limited influence on the number of abortions

• Has a profound influence on the conditions under

which the abortion is performed

• Has a significant effect on women’s health

• A liberal abortion law is a prerequisite for the

development of safe abortion methods

Page 4: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Year Pregnancy length (weeks)  

  -12 13 -16 17-20 21- 24

1964 10% 27,9% 54,9%

7.4%

17.0 weeks

     

 

      

   

           

Källa: Rätten till abort SOU 1971:58 och EPC Socialstyrelsen

  -11 12-17 18+

   

2002 93,3% 6.0% 0,7%

  8,1 weeks

Mean

Percentages of abortionsin relation to pregnancy week

Page 5: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Mifepristone abortion in Sweden

• 1992: up to 63 days

• 1994: II-trimester abortion

– 600 mg mifepristone followed by gemeprost

1mg/ 3h

– 2003: 600 mg mifepristone followed by a

suitable prostaglandin analogue

Page 6: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortion 1996 to 1998

• 197 consecutive abortions in 192 women

• Regimen:

– 600 mg mifepristone

– 24 to 48 h later gemeprost 1mg every 6 hours x 4

– If no abortion within 24 h, I mg gemeprost / 3 h

• Curettage routinely performed up to 18 weeks,

thereafter when neededGemzell Danielsson K & Östlund 2000

Page 7: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Demography

• Median age: 30 (15 to 44) years

• Median pregnancy length: 17 (14 to 26) weeks

• Primigravidae: 42 (21.3) %

• Multigravidae: 155 (78.7) % (Nulliparous (n=45))

• Indications:

– Social (n=113) 57.4 %

– Chromosomal aberration (n=30) 15.2 %, Foetal malformation (n=34) 17.2%, Missed abortion (n=20)

10.2 %

Page 8: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Results

• Median numbers of gemeprost (Cervagem): 2

• Induction-to-abortion interval:

– Primigravidae: 9.0 (1.4-40.5) h vs.

– Multigravidae: 7.2 (0-152.5) h (ns)

• Nulliparous (n=45) 10.6 (2.8-30.6) h vs.

• Parous (n= 104) 6.0 (0-152.5) h (p<0.001)

Page 9: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Results

• 96.3 % aborted within 24 h (all women with missed abortion)

• Significant correlation between pregnancy length and

abortion time

• Narcotic analgesia required by 93 %

• PCB (n=8)

• EDA (n=1)

• One woman required a blood transfusion

Page 10: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortion200mg mifepristone and gemeprost

• Case series report

• 200mg mifepristone followed 36h later by 1 mg

gemeprost/6h x4, /3h

• Median gestational length 16 weeks (12-24 w)

• Median induction-to-abortion interval 7.8h

• Surgical evacuation 11.5%Tang OS, Thong KJ, Baird DT, Contraception 2001

Page 11: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortiongemeprost vs.misoprostol orally

• 50 women

• 200 mg mifepristone followed by

• 400 g misoprostol p.o/ 3h or 1 mg gemeprost/ 6h

• Induction – abortion interval 8.7 vs. 10.8 h (ns)

• No difference in incidence of side effectsHo et al., 1996

• Similar efficacy: El Refaey et al., 1993, Dickinson et al., 1998,

Nuutila et al., 1997

• Higher efficacy: Wong et al., 1996

Page 12: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortion misoprostol 3h vs. 6h intervals

• 148 women

• Misoprostol 400 g vaginally

• Repeated every 3h vs. 6h

• Induction-ab interval 15.2 vs.19.0 h (P< 0.01)

• Abortion within 48 h 90.5 vs. 75.7% (P< 0.02)

• Fever more common in the 3h group (P = 0.01).

Wong et al., 2001

Page 13: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II - trimester abortion oral vs. vaginal misoprostol

• 142 women: 200 mg mifepristone +

misoprostol 400 g oral vs. 200 g vaginal/ 3 h up to x 5

• Complete abortion rate: 81.4% vs.75.4% (ns.)

• Diarrhoea 40 vs. 23.2 % (p= 0.03)

• Total dose 1734 vs. 812 g (p< 0.0001)

• Median induction-to-abortion interval: 10.4 vs. 10 h

• 82% preferred the oral routeNgai et al. 2000

Page 14: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortion

• 200 mg mifepristone followed 48h later by

– Misoprostol 400 g vaginally every 3h vs.

– Misoprostol 600 g vaginally + 400 g po/ 3h

• No significant difference between the

groupsEl-Refaey & Templeton 1995

Page 15: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortion 1000 women, 13-21 weeks

Mifepristone 200 mg, after 36-48 h followed by

– vaginal misoprostol 800 g (4 tabl Cytotec) followed by

– 400 g po.(2 tabl Cytotec) every 3h to max 4 doses

• 97% aborted successfully

• median dose of misoprostol: 1200 g

• median induction-to-abortion interval: 6.5 h.

• 9.4% curettage, > 75 % day casesAshok & Templeton 1999, 2004

Page 16: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortionsublingual misoprostol

• Significantly higher acceptance for sublingual

administration

400 microg misoprostol/ 3h x 5 vaginal. vs. SublingualTang et al., 2004

• Higher acceptance for sublingual but more pain,

more opiates needed

600 microg sublingual vs. 800 microg vaginal followed by 400

microg /3h sublingual or vaginalHamoda et al., 2005

Page 17: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Effect of the time interval between mifepristone and the prostaglandin

• No difference in induction to abortion time with

mifepristone administered 24, 36 or 48 h prior to the

prostaglandinUrquhart and Templeton 1990

• Effect on uterine contractility maximal at 36 to 48hBygdeman & Swahn 1985

• Ripening effect of mifepristone on cervix, more

pronounced at 36 to 48 hRådestad et al 1988

Page 18: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

The contraindication is unfounded

NSAIDs are prostaglandin synthetase inhibitors

Effect of mifepristone on uterine contractility: , regardless of

NSAID administration (Norman et al.,)

No effect on cervical ripening when coadministered with

misoprostol (Ho et al)

Efficacy of medical abortion is the same, when NSAIDs

prophylaxis is used

Shortened induction-to abortion interval and less misoprostol in

nulliparaousFiala et al Human Reprod 2005

Arguments for the use of NSAIDs

Page 19: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Conclusion Mifepristone in II-trimester abortion

• Our data confirm the efficacy and safety of

mifepristone and gemeprost for II-trimester abortion.

• Oral misoprostol has been shown to be as effective

and safe as gemeprost

• Vaginal misoprostol is more effective but less

accepted than the oral route

• The combined vaginal-oral regimen is as effective as

repeated vaginal misoprostol

Page 20: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

II-trimester abortion

Mifepristone followed 24-48h later by

Misoprostol 800 g (CytotecR 4 tabl ) vaginally followed

by 400 g (CytotecR 2 tabl) orally

every 3h

Curettage only in case of incomplete abortion

Page 21: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-timester abortion, K Gemzell Danielsson

Pain prophylaxis

• T Diclofenac 100 mg T Panocod.® together with the first

dose of Cytotec

• Contraceptive councelling

• Screening and treatment/ prophylactic antibiotics for STI

Page 22: II-trimester abortion with Mifepristone Kristina Gemzell Danielsson, Dept of Obst. & Gyn Karolinska University Hospital / Institute, Stockholm, Sweden

II-trimester abortion with II-trimester abortion with MifepristoneMifepristone

Kristina Gemzell Danielsson,

Dept of Obst. & Gyn

Karolinska University Hospital / Institute,

Stockholm, Sweden

FIAPAC, Moscow, October 2005

[email protected]