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FIRST TRIMESTER INDUCTION PROTOCOLS AND COMPLICATIONS

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

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FIRST TRIMESTER INDUCTION PROTOCOLS AND COMPLICATIONS

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

  2. 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)

  3. 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

  4. TERMINOLOGIES 33rd RCOG Study Group 1997

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

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

  7. 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.

  8. 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

  9. 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

  10. 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)

  11. 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).

  12. 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

  13. 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)

  14. 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

  15. 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)

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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)

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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)

  30. 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

  31. 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)

  32. Rupture up to 4% in Previous CS and High Parity after 12 wks ( 12-24 wks )

  33. 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

  34. 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 .

  35. 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

  36. 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%

  37. 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

  38. 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

  39. 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)

  40. 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

  41. (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)

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

  43. 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

  44. (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

  45. 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

  46. THANK YOU

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