Russian experience of medical abortion T. Astakhova, A. Kuzemin, D. Jerdev Research Center for Obstetrics, Gynecology and Perinatology (Director – professor.

Russian experience of Russian experience of medical abortionmedical abortion

T. Astakhova, A. Kuzemin, D. JerdevT. Astakhova, A. Kuzemin, D. JerdevResearch CenterResearch Center for Obstetrics, for Obstetrics, Gynecology and Perinatology Gynecology and Perinatology

((Director – professor V.I. KulakovDirector – professor V.I. Kulakov))Moscow 2005

Russian experience in medical Russian experience in medical abortions abortions

for pregnancy termination for pregnancy termination

• 1975-80 1975-80 yryr. – . – synthetic analogues of PRsynthetic analogues of PR 15 ме Р15 ме РgF2gF2αα, , hemeprosthemeprost, , sulprostonsulproston

• 19819822-90 -90 yryr. – . – syntheticsynthetic steroid drugs –steroid drugs –

antiprogestinsantiprogestins RU-RU-486486 (mifepristone (mifepristone), ), mifeginmifegin

• 1993-2005 1993-2005 yryr.– .– antiprogestinsantiprogestins + + PGPG

mifepristonemifepristone, , penkroftonpenkrofton misoprostolmisoprostol

Russian pharmaciesRussian pharmacies

• MIFEPRISTONEMIFEPRISTONE

MIR-PHARMAMIR-PHARMA• PENCROFTONPENCROFTON

PENCROFT-PENCROFT-PHARMAPHARMA

Clinical research of mifepristoneClinical research of mifepristone

• Research Center for Obstetrics, Gynecology and Research Center for Obstetrics, Gynecology and PerinatologyPerinatology, , Moscow, RussiaMoscow, Russia

• Sechenov Medical Academy Clinic for Obstetric and Sechenov Medical Academy Clinic for Obstetric and Gynecology, MoscowGynecology, Moscow

• Military-medical Academy, St-PetersburgMilitary-medical Academy, St-Petersburg• V.N.Gorodkov’ Research Center for Mother and Child,V.N.Gorodkov’ Research Center for Mother and Child, IvanovoIvanovo• Professional Association of Gynecologists-oncologistsProfessional Association of Gynecologists-oncologists,, St-PetersburgSt-Petersburg• RepublicanRepublican Medical centerMedical center « «FamilyFamily», », CheboksariCheboksari

State Pharmacologic Committee State Pharmacologic Committee

Public Health ServicePublic Health Service hashas approved use approved use of mifepristoneof mifepristone

((RegReg. № 002340/0102003 от 07/04/2003 . № 002340/0102003 от 07/04/2003 г.). г.). and was recommended for clinical and was recommended for clinical

useuse..

INDICATIONSINDICATIONS

• Request of patientRequest of patient

• Uterine pregnancy (less than 6 weeks) Uterine pregnancy (less than 6 weeks) confirmed by ultrasoundconfirmed by ultrasound

• Women, who might have some difficulties Women, who might have some difficulties when performing instrumental evacuationwhen performing instrumental evacuation::

--uterine malformationuterine malformation --pregnancy and intact uterine hymenpregnancy and intact uterine hymen

CONTRAINDICATIONSCONTRAINDICATIONS

• Ectopic pregnancy or suspicion on ectopic Ectopic pregnancy or suspicion on ectopic pregnancypregnancy

• Adrenal insufficiencyAdrenal insufficiency• Long-term corticosteroid therapyLong-term corticosteroid therapy• Renal and hepatic insufficiencyRenal and hepatic insufficiency• Allergic reaction on mifepristoneAllergic reaction on mifepristone and and

misoprostolmisoprostol• Blood diseases and anticoagulant Blood diseases and anticoagulant

therapytherapy• Big size uterine myomas Big size uterine myomas • STD in acute stageSTD in acute stage

Recommended check-upRecommended check-up

• CounselingCounseling

• Gynecologic examGynecologic exam

• UltrasoundUltrasound

• Analysis for HIV, syphilis, Hepatitis B, Analysis for HIV, syphilis, Hepatitis B, CC

• Blood group, RhBlood group, Rh

• Vaginal specimenVaginal specimen• Analysis for Analysis for ββ-HCG-HCG

• CoagulogrammCoagulogramm

• Blood clinical analysisBlood clinical analysis

Induced abortionInduced abortion: : protocol and dynamic observationprotocol and dynamic observation

• Visit 1Visit 1 Confirmed uterine pregnancy no more than 6 Confirmed uterine pregnancy no more than 6

weeks weeks (42 (42 days of amenorrheadays of amenorrhea)) Informed consentInformed consent MifepristoneMifepristone (600 (600 mgmg per os)per os)

• Visit 2Visit 2 After 36-48 hours After 36-48 hours ProstaglandinsProstaglandins ( (misoprostol)misoprostol) 400 mgr per os400 mgr per os

• Visit 3Visit 3 10-14 days 10-14 days later afterlater after mifespristonemifespristone administration administration Efficacy of induced abortionEfficacy of induced abortion ((clinical examclinical exam, , ultrasoundultrasound).).

Clinical descriptionClinical descriptionof induced abortionof induced abortion

I periodI period - - latentlatent

CharacterizedCharacterized

by absence of clinical by absence of clinical manifestations of manifestations of

pregnancy pregnancy termination during termination during

24-48 hours24-48 hours(28,6±2.3) (28,6±2.3) from the from the

mifepriston mifepriston administrationadministration

IIII periodperiod - - mainmain

Characterized Characterized

by menstrual-like by menstrual-like

reactionreaction, , appearing appearing

with mild to moderate with mild to moderate

bleeding which lasts bleeding which lasts

for 5-18 daysfor 5-18 days

EFFICACY CRITERIAEFFICACY CRITERIA

-- Normal uterine sizeNormal uterine size, , absence of painful absence of painful feelingsfeelings, , there may be mild blood spotsthere may be mild blood spots

- - Absence of embryonal sac or its Absence of embryonal sac or its elements in uterine, confirming by elements in uterine, confirming by ultrasoundultrasound

- - Decrease of Decrease of --HCG in blood sampleHCG in blood sample

β-HCG

0

5000

10000

15000

20000

25000

30000

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Days

МЕ

/Л

,

Progesteron

0

10

20

30

40

50

60

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Days

нм

ол

ь/л

Dynamic in decrease of the hormone’s levels

Ultrasound examination before Ultrasound examination before and 14 days laterand 14 days later

after mifepristoneafter mifepristone administration administration Before 14 days after

Mifepristone concentrationMifepristone concentrationin serum afterin serum after its usingits using

0

500

1000

1500

2000

0 6 12 18 24 30 36 42 48 54 60 66 72

Т

С (

нг/м

л)

CLINICAL EFFICACYCLINICAL EFFICACY MEDICAL ABORTION MEDICAL ABORTION (%)(%) ACCORDING THE USED PROTOCOLSACCORDING THE USED PROTOCOLS

Research Center for Obstetrics, Gynecology and Perinatology

mifepristone mifepristone+misoprostole

100%

0 %

88% 98%

SIDE-EFFECTS, % (n=2565)Research Center for Obstetrics, Gynecology and

Perinatology

1,45

3,62

9,42

19,59

19,71

3,65

2,08

1,37

0,68

13,7

20,69

22,07

8,28

1,48

0 5 10 15 20 25

DIARHEA

VOMITING

NAUSEA

FATIGUE

MILD PELVIC PAIN

SEVERE PELVICPAIN

SEVERE BLEEDING

mifepristone

mifepristone+misoprostol

%

Complications after instrumental andComplications after instrumental and medical abortionmedical abortion (%) (%)

Research Center for Obstetrics, Gynecology and Perinatology

0 1 2 3

PERFORATION OF UTERUS

HEMMORHAGE

PROGRESSING PREGNANCY

RETENTION OF PLACENTALFRAGMENTS

ENDOMETRITIS

HEMATOMETRA

UTERUNE SYNECHIA

MEDICAL INDUCTION

INSTRUMENTALABORTION

%

Failure of medical abortionFailure of medical abortion

Progressive pregnancy Progressive pregnancy

or incomplete abortionor incomplete abortion

Vacuum aspiration/ Vacuum aspiration/ Surgical curettageSurgical curettage

ADVANTAGES OF MEDICALLY INDUCED ADVANTAGES OF MEDICALLY INDUCED ABORTIONABORTION

• High efficacyHigh efficacy 98 %, 98 %, safety andsafety and compliencecomplience• Absence of complications vs instrumental abortionAbsence of complications vs instrumental abortion: :

mechanical damage of uterine andmechanical damage of uterine and uterine vesselsuterine vessels, , cervix injurycervix injury

• DecreasesDecreases of possibility of ascending infection and of possibility of ascending infection and complications dealing with itcomplications dealing with it

• No risk of anesthesia (no need)No risk of anesthesia (no need)• MifepristoneMifepristone is the drug of choiceis the drug of choice in nulliparousin nulliparous• No psychogenic sequelaeNo psychogenic sequelae• High acceptability of method resultsHigh acceptability of method results