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FIRST TRIMESTER INDUCTION PROTOCOLS AND COMPLICATIONS. Dr.A.R.Vijayalakshmy DGO,MD,MRCOG Senior Consultant( O& G) Khoula Hospital. INTRODUCTION.

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slide1

FIRST TRIMESTER INDUCTION PROTOCOLS AND COMPLICATIONS

Dr.A.R.Vijayalakshmy DGO,MD,MRCOG

Senior Consultant( O& G)

Khoula Hospital

slide2

INTRODUCTION

  • First Trimester Induction applies to those terminations on Medical grounds and Miscarriage
  • Miscarriage occurs in 10-20 %
  • Surgical Evacuation – Conventional method
  • Effective Non Surgical Alternatives
  • Early Pregnancy Assessment Units (EPAU)
slide3

EAPU(Bigrigg and Read 1991)

  • Streamlines the management of early pregnancy problems with improved efficiency and quality
  • Hospital admissions reduced by 40% and 20% shorter stay
  • Cited in a dedicated area with
  • Appropriate Staffing and Facilities
  • Efficient Appointment system
  • Direct access for GPs and selected patient groups
  • TVS,BHCG,Serum Progesterone
  • Available on all days ,minimum 5 days in the morning ,Clinical Guidelines for management
slide4

TERMINOLOGIES

33rd RCOG Study Group 1997

slide5

European Society for Human reproduction Special Interest Group for Early Pregnancy - Revised Nomenclature(2005)

slide6

MANAGEMENT

  • History/Preexisisting conditions(Cardio resp,Coag.disorders)
  • Examination ,Ultrasound
  • Investigations
  • Informed Consent
  • Management Options
    • Expectant
    • Medical Algorithm
    • Surgical
slide7

INDUCED MISCARRIAGE - FIRST TRIMESTER

Mifepristone Misoprostol /Methotrexate Misoprostol or Misoprostol alone

IPPF and WHO 2007

Mifepristone 200mg followed 36–48 hours later by 800μg misoprostol (orally, sublingually, buccally or vaginally)at once or in two doses of 400μg two hours apart, up to 9 completed weeks after last menstrual period.

slide8

US FDA

Day 1: Mifepristone 600mg (three 200mg tablets) taken as a single oral dose.

Day 3: Unless abortion has occurred and is confirmed by clinical examination or ultrasound administer misoprostol400μg (two 200μg tablets) as a single oral dose

slide9

Methotrexate/Misoprostol Protocol ( OBG Society of Canada 2008)Methotrexate 50mg/SqM Intramuscular on the deltoid

  • On5th,6th or 7th day afterMethotrexate, 800ugm Vaginally
  • If no bleeding or passage of tissue after 24 hrs, rpt 800 ugm
  • On the D3 and D7 days
  • If Bhcg has fallen by >80% over 7days,procedure was successful
  • If not, a weekly Bhcg estimation till level reaches 0 or interval decrease is >80%
  • If Bhcg level plateaus or increases - Incomplete miscarriageor ongoing gestation - Suction Evacuation
  • Once termination is complete ,confirm a nonpregnant non tender uterus by bimanual pelvic examination
slide10

INDUCED MISCARRIAGE PROTOCOL (CONTD )

MISOPROSTOL ALONE

Misoprostol 800ugm Vaginally–every 24 or 48 hrs ( Day1-5) until abortion occurs or a total of 3 doses

Bhcg on Day 1 and D7.If Fallen >80% -success. Repeat another after 1 wk to ensure continued decline .

If not fallen to the desired level, rpt wkly till reaches 0 or interval decrease is > 80%

If rises or plateaus -- Vacuum aspiration

Ultrasound may be used instead of B hcg assays

WHO Expert Group 2007

Misoprostol 800 ugm Vaginally12 hrlyx 3doses ( Ideally after 48 hrs of Mifepristone 200 mg)

slide12

EXPECTANT MANAGEMENT IN MISCARRIAGES

  • Effective and acceptable for selected group of women (Level 1b).
  • Should be offered to women who have access to emergency admission if required.
  • Successful in 2-6 wks without increasing complications in 80-90% of women with Incomplete miscarriage and 65-75% of women with Delayed miscarriage/Empty sac (Butler C. et al J.Fam.Practice 2005).
slide13

EXPECTANT MANAGEMENT IN MISCARRIAGES (CONTD.)

  • Those with intact sac may take several wks and efficacy low.
  • Success depends on various factors like
    • Type of miscarriage
    • Duration of follow up
    • Ultrasound or Clinical
  • Low serum Progesterone may be used to predict outcome
slide14

SURGICAL MANAGEMENT( Suction Evacuation)

  • Treatment of choice for Intact sac ,Incomplete miscarriage with ET >50 mm ,Heavy bleeding, Unstable Vital signs or Infection,Suspected molar pregnancy ,Patient’s choice
  • Advantage of Suction Evacuation
  • Safe and Quick
  • Significantly reduced blood loss( Cochrane review 2001)
  • Need for Cervical priming assessed ( Misoprostol 400 ugm) oral or vaginaly)4 -12 hrs prior
  • Reduces cervical laceration and uterine perforation up to 80%

Antibiotic Prophylaxis individualised( 1gm Metronidazole) rectally at surgery followed by oral Doxycyclin 100mg BDx 7days)

slide15

SURGICAL MANAGEMENT ( CONTD)

  • Canula size in mm should be equal to or > than the Gest.age in weeks ( B)
  • Use of Oxytocin associated with clinically significant decrease in mean blood loss ( 17.6 mlVS 24.5 ml ) Level 1a
  • Suspected Infection – Intravenous Antibiotics for 12 hrs prior to Evacuation
  • Serious Morbidity and Mortality– 2.1% and 0.5/100,000 in Induced abortion( Level 3 Evidence)
  • Others
  • Incomplete Miscarriage  2/1000, Haemorrhage,Cervical trauma,uterine trauma  1/1000
slide16

COMPLICATIONS

Cervical shock ( Vasovagal )– Para cervical block  Tonic Clonic reaction – confused with seizure

Bradycardia, rapid recovery ,absence of post ictal state – differentiates

Pre op Cervical priming – prevents the Cervical shock

Perforation –Presentation depends on the site

At Isthmic portion– May lacerate the ascending branch of uterine artery--- haematoma in the broad ligament/ intraabdominal bleed

Immediate Laparotomy and ligation of severed vessels / repair of uterine injury/Hysterectomy( rarely)

slide17

COMPLICATIONS (CONTD )

  • Low Cervical perforation - May injure descending branch of Uterine artery in the Cardinal ligament- due to forcible dilatation
  • Deaths due to delayed bleeding can occur hrs or days later
  • Management - Embolisation /Hysterectomy
  • Fundal Perforation- Stop the Suction ,Laparoscopy/ Laparotomy and complete the evacuation under vision ,repair the damage
  • Haemorrhage– Uterine atony,Lowlying limplantation, Perforation
  • Misoprostol 1000ugm rectally /Oxytocin /IM PG f2 Alfa
  • Persistent bleeding– Retained tissue,Perforation
slide18

MEDICAL MANAGEMENT - As Out patient ( Level 1b)

  • Induced miscarriage
  • Incomplete ,Silent/Delayed / Missed miscarriage
  • Early fetal demise
  • Variety of regimens described including Gemeprost, Mifepristone followed by Misprostol ,Methotrexate - Misoprostol and Misoprostol alone
slide19

Misoprostol > 600 studies 90,000women

PGE1 analogue ,cheap, highly effective,acts via various routes , easy storage ,fast absorption ,peaks after 12 minutes of oral and 60minutes after vaginal Half life 20-30 minutes

( Bioavailability varies with route)

Myometrial contractions by interacting with specific receptors on myometrial cells -- Cascade of events change in calcium concentration and muscle contraction

slide20

MEDICAL MANAGEMENT CONTD

  • Alternative method- does not replace surgical evacuation
  • Availability Improved choice
  • 20% willing to choose medical method as could avoid anesthesia and feels more in control ( Level 1 b)
  • Local protocols should be developed with selection criteria ,theraputic regimen and follow up ( Good practice)
  • Should be counselled that bleeding may continue for 3wks
slide21

Rule out Contraindications

Absolute

Adrenal insufficiency ,Long term steroid trt , Hb<10 gm%, Hemoglobinopathies,Glaucoma,Mitral stenosis ,Coagulation disorders,Hepatorenal diseases,Acute Inflammatory bowel disease , Porphyria ,NSAIDS ingestion in the preceding 48 hrs(?) Pelvic infection/sepsis, known allergy

Relative – Hypertension, Severe Asthma

slide22

To date no standard protocol for the use of Misoprostol as single agent

  • Variety of doses and differing dosing schedules

Success depends on various factors like

  • Type of miscarriage,Sac size ,Total dose ,Route,Duration,Clinical or US follow up
  • High success rates with Incomplete ,High dose Vaginal and Clinical follow up
slide23

INCOMPLETE MISCARRIAGE (Upto 12 wks

  • Single oral dose of 600 ugm - Successful in > 1000 women in > 6 trials world wide( Int.J OBG 2007)
  • Vaginal 800ugm –Single dose ,Oral 400ugm Single dose
  • Single and Rpted doses of oral 600ugm ,maximum 1200 ugm –found to be equally effective ,lower incidence of diarrhoea in single dose group ( Ngutyen TN etal –Contraception 2005)
  • Success 61-95%,bleeding for 6 days
slide24

Sublingual 400 ugm has also been evaluated - Success of 94.5%

Both Sublingual 400 ugm and Oral 600 ugm –Equally effective for Incomplete miscarriage ( FIGO 2006 )

In many low resource countries ,with women having limited access to Secondary and Tertiary Care ,could use for Incomplete miscarriage ( 17th Expert Committee on Selection & Use of Essential Medicines, Geneva March 2009)

slide25

Cohrane Review including 19RCT on Pregnancies <14 wks reported that Vaginal Misoprostol reduces the time to expulsion when compared with Placebo

Doses used 400 ,600 or 800 ugm.

Lower doses 2RCT-less effective

slide27

CONTD

    • Hospitalisation not necessary
    • Time to expulsion varies ,bleeding heavy for 3-4 days may last >14 days with additional days of spotting
    • Women with Previous CS
    • No reason to withhold ,while many trials have excluded
    • For Uterine size < 12 wks misoprostol reported safe with scar
slide28

ADVANTAGES OF MEDICAL METHODS

  • Does not increase the infection rate
  • Avoids surgery and anaesthesia
  • Emotionally easier for some women
  • Client controlled; more privacy and autonomy;
  • Better than surgical in very early gestation, or with
  • severe obesity (body mass index >30) without other cardiovascular risk factors, or in the case of fibroids, uterine malformations or previous cervical surgery
  • No risk of cervical/uterine injury
slide29

SILENT ,DELAYED ,MISSED OR EARLY FETAL DEMISE

A Confusing number of regimes using Misoprostol alone(Oral,Sublingual or Vaginal) in doses of 400,600 or 800 ugm in single or repeated doses

Oral Mifepristone 200,400 or 600 mg followed by 36-48 hrs later by Misoprostol or Gemiprost 0.5- 1mg Vaginally

Success with Mifepristone+ Misoprostol -70-84%with Induction to miscarriage time of 8hrs and Satisfaction rate of 91% ,Bleeding stopped in 8 days

Mifepristone not necessary in above miscarriages as Progesterone levels are low

slide31

Vaginal route preferred -Early expulsion than Oral

Sublingual route –Fatigue and diarrhoea higher ( Tang OS et al , Human Reproduction 2003,NgOC et al Int.J O&G2004

Single dose Vaginal 800ugm –more effective than 400 ugm (55% VS 40.2 %) in delayed miscarriage compared with empty sac (50 % Vs 40%)

Larger and Rpt doses needed in those with Empty sac

There is no randomised evidence to guide practice in cases of 1st Trimester miscarriage particularly in cases of intact sac

Suction evacuation - high satisfaction and acceptability

slide32

SOME OF THE REGIMENS IN EARLY PREG.FAILURE

  • Chung et al 1995 - 400 ugm oral 4hrly 3doses ,141pt - 62%
  • Nielson et al 1997 -400 mg Mifepristone -36 hrs Oral Miso 400 ugm – 31 pts , 52%
  • Zalayani et al 1998 – 200 ugm Vaginally 4hrly X 4doses – 25pts -88%
  • WoodSL et al 2002 - 800 ugm Vaginal ,Rpt at 24 hrs – 50 pts- 84%
  • TangOS et al 2003 – 600 ugm Vag or SL 3hrlyx 3doses – 80 pts – Successs -87.5% in both , diarrhoea ,fatigue more in SL,otherwise comparable side effects ( RCT)
slide33

CONTD.

  • Davis AR et al 2002 – 800 ugm Vag -24 hrlyx 2 doses – 80 pts – 85%
  • Ngoc et al 2004 – 800 ugm Oral or Vaginal – 200 pts 89 % and 92.9% success
  • Reynold et al 2005 – 600 ugm Vaginally 4hrly x 3 doses – 44 pts – 86 %
  • Zhang 2005 - 800 ugm Vaginal – Rpt at 48 hrs if POC - 652 pts ,77% after 1 dose and 84 % after 2 doses
  • WHO Expert Group 2007 – 800 ugm Vaginally 3hrly or Sublingual 600ugm 3hrly – Give 2 doses and leave for 1-2 wks
slide34

SIDE EFFECTS AND COMPLICATIONS

Rarely mild rash

Infection rate - Not different from other methods ( 2%) Vs 3%

No adverse effect on future fertility ( Level 1a)

slide36

COMPARISON BETWEEN DIFFERENT MANAGEMENTS

  • Only few RCT comparing Expectant ,Medical and Surgical for Incomplete Miscarriage and Early fetal demise
  • MIST trial ( BMJ 2006 ) Trinder J et al. Signicantly more unplanned admissions and surgical curettage after Expectant and Medical management than Surgical
  • Infection rate was low ( 2-3 % ) regardless of method
slide37

A meta analysis reported in Obst.Gyn 2005 ,Surgical had the best success rate followed by Medical and Expectant although many were of poor methodological quality

Cochrane review 2006,Expectant –> High risk of incomplete miscarriage,bleeding ,need for surgical evacuation .

slide38

However no strong argument for either approach

  • Individual woman’s preferrence - major concern
  • Filmy adhesions reported in7.7% of Surgical cases
  • Longterm conception rates and pregnancy outcome similar in both Medical and Surgical methods
  • Median time to achieve pregnancy – 8 months
  • Cost – Misoprostol least costly,followed by Expectant and Surgical Evacuation ( Pooled data)
  • Other studies – Report otherwise
slide39

WOMAN’S PERSPECTIVE ABOUT DIFFERENT CHOICESA Survey done by (Molnar AM et al 2000 ) in women attending Family planning Clinics

Strong preferrence for Expectant management ,although Physician’s recommendation would infuence the decision.

No Single Best Way to treat Miscarriage to suit all women.

Largest Qualitative study of women’s views on Various management options ,concluded that Informed Choice was paramount

SATISFACTION RATES

Highly acceptable for Incomplete miscarriage – 96.8% ,would choose the same again – 94.5% ,would recommend to a friend -94%

slide40

HISTOPATHOLOGY

Of Products of conception - should be sent to rule out Trophoblastic disease and Ectopic pregnancy

DISPOSAL OF THE POC

Each Hospital should have clear system and protocol for sensitive disposal of the fetal remains

Record keeping poor

Should have National Guidelines for the same

slide41

ALGORITHM FOR MANAGEMENT OF MISCARRIAGE (Obstetrician and Gynaecologist 2007)

THREATENED MISCARRIAGE

Active bleeding  Admit for reassurance

Follow up if

Haematoma

Decrease in Liqour

Fetal bradycardia

Rescan 2 wks

COMPLETE MISCARRIAGE – ET < 15 mm

Report if bleeding doesn’t stop in 2 wks

slide42

INCOMPLETE MISCARRIAGE - ET 15-50 OR >50 MM

Type 1 - Expectant- If bleeding is not heavy ,continue as long as per the woman’s wish ,with scan at 1-2 wkly intervals till complete miscarriage occurs.If heavy bleeding  Surgical management

Medical - If woman not willing to wait – Vag.Prostaglandins Gemeprost 0.5mg, Gemeprost 1mg,Misoprostol 800 ugmIf heavy Bleeding /Infection /Changes the mind  Surgical

Surgical Strong preference

Heavy bleeding Assess need for priming

Infection ( under antibiotic cover)

slide43

ET > 50 mm

Surgical Strong preference

Heavy bleeding Assess the need for

Infection priming

SILENT /MISSED/DELAYED /EARLY FETAL DEMISERescan1wk , If no change

Expectant As in incomplete

Medical Woman not willing to wait

Oral Mefipristone 200 mg followed by

36-48 hrs later Vag.PG ,Gemeprost 0.5mg /1mg

Misoprostol 800 Ugm ( 4 x 200 Ugm)

single dose for < 9wks , > 9wks 3hrly x 5doses

slide44

(CONTD)

SURGICAL -As with ET >50mm

AntiD Prophylaxis if Rh –ve(50ugm)

Threatened miscarriage >12 wks

<12 wks if heavy bleeding

Confirmed miscarriage >12 wks

<12 wks if Evacuation

(Medical & Surgical)

slide45

KHOULA HOSPITAL STATISTICS

Misoprostol priming with 200 ugm used in 120 cases ,45 cases in 2nd trimester miscarriages and IUFD ,10 cases of PPH

slide46

CONCLUSION AND RECOMMENDATION

  • Early Pregnancy Assessment Units
  • Patient’s choice
  • Counselling
  • Misoprostol priming before evacuation
  • Out patient management for Expectant and Medical
  • Rule out Contraindications
  • Prevention of Misuse – Mandatory
slide47

(CONTD)

  • Incomplete Miscarriage – Misoprostol 600 ugm single oral dose
  • Delayed Miscarriage – 800ugm Vaginally 24 hrly x 2doses
  • Induced miscarriage - 800 ugm Vaginally every 24-48 hrs maximum of 3 doses
  • Follow up at 2 wks
  • Antibiotic prophylaxis - Evacuation
  • Markers to predict spontaneous resolution – IGF BP -1, Inhibin A and Inhibin Pro a-CRI
slide48

REFERRENCES

1) Cochrane Database Systematic Review 2004

2)Consensus Statement – Instruction for Use- Misoprostol for Incomplete abortion and Miscarriage –Expert Meeting on Misoprostol – Reproductive Health Technology Project 2004

3)International Parenthood Federation ( First Trimester Abortion Guidelines and Protocols ) 2004

4)Greentop Guidelines No 25 -2006

5)Supplement to International Journal of Obstetrics and Gynecology 2007,Vol 99

6) Obstetrician and Gynaecologist 2007 ;9: 102-108

7)Council of the Society of Obstetrics and Gynecology of Canada ,Induced Abortion Guidelines Dec19,2008