Standard Management protocol for ECLAMPSIA

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1 RESOURCE RESTRICTED SETTINGS Standard Management protocol for ECLAMPSIA KSOGA /12/16 1

2 PROTOCOLS MEDICINE is an imperfect science, an enterprise of constantly changing knowledge, uncertain information, fallible individuals, at the same time lives on the line" 02/12/16 KSOGA

3 POOR RESOURCE SETTINGS l RESTRICTED RESOURCE SETTINGS RESTRICTED - RESOURCE SETTINGS 02/12/16 KSOGA

4 UNEQUAL EQUATIONS v 27,000,000 DELIVERIES PER YEAR l OBSTETRICIANS v 1 OBSTETRICAN FOR 1000 DELIVERIES l 50 % UNATTENDED HOME DELIVERIES 02/12/16 KSOGA

5 RESTRICTED- RESOURCES l Resources available l Usage restricted 1. suboptimal usage of infrastructure 2. suboptimal usage of human resource 02/12/16 KSOGA

6 Global Scenario Maternal Mortality 2010 Hemorrhage 24.8% Annually, 2,87,000 women die of pregnancy related complica9ons Infection 14.9% Eclampsia 12.9% Obstructed Labor 6.9% Unsafe Abortion 12.9% Other Direct Causes 7.9% Indirect Causes 19.8% 02/12/16 KSOGA

7 BURDEN of PE/E Eclampsia and preeclampsia account for approximately 63,000 maternal deaths annually worldwide Vigil-De Gracia P. Maternal deaths due to eclampsia and HELLP syndrome. Int J Gynaecol Obstet. Feb 2009;104(2): /12/16 KSOGA

8 PARADOX No woman in this day and age should die from eclampsia just because simply she happens to live in a village. this is a tragedy, because we have an effective, low-cost, and safe solution. 02/12/16 KSOGA

9 400 to 200 by 400 l MMR reduced from 400+ to 200- l By spending rupees 400 per mother Dr. Sabaratnam Arulkumaran FIGO President 02/12/16 KSOGA

10 NEED OF THE HOUR n 1. Guidelines and Protocols at the National Level n 2. Modifications in the G/P to suite the LOCAL LEVEL VIMS STUDY RESEARCH ANALYSIS VISRA 02/12/16 KSOGA

11 NEWER THINKING Three stage management strategy for management of eclampsia Primary management,at or near the place of convulsion. Seizure Free Transportation of the patient Tertiary level management in DISTRICT HOSPITAL or HDU KSOGA

12 Treat all women with convulsions in pregnancy as eclampsia until proven otherwise. BP may be normal! 02/12/16 KSOGA

13 ECLAMPSIA According to ACOG eclampsia is defined as convulsions occurring in a patient with preeclampsia. PREECLAMPSIA IS HYPERTENSION + ECAMPSIA IS A COMPLICATION OF PREECLAMPSIA Rx..HYPERTENSION 02/12/16 KSOGA

14 Standard Management Protocol HDU 02/12/16 KSOGA

15 OLD HABITS DIE HARD NIGERIA Kano State : 46.3% of maternal deaths Birnin Kundu: 43.1% Yenagoa: 40% Ilorina: 27.5% ONLY 3 OUT OF 10 TRAYS HAD MgSO4. B. A. EKELE..SOKOTO REGIMEN

16 Standard Management Protocol DO NOT LEAVE THE PATIENT ALONE A PLACE IN LEFT LATERAL POSITION B CALL FOR HELP C 02/12/16 KSOGA

17 PROTOCOL DO NOT CONCENTRATE ONLY ON ANTICONVULSIVE REGIMENS. ANTICONVULSIVE MgSO4 02/12/16 ANTIHYPERTENSIVE I.V. LABETALOL KSOGA

18 PROTOCOL DO NOT CONCENTRATE ONLY ON ANTICONVULSIVE REGIMENS. ANTICONVULSIVE MgSo4 ANTIHYPERTENSIVE I.V LABETALOL

19 PRITCHARD S REGIMEN CONTROL CONVULSIONS Loading Loading dose: 4g (20 ml of 20%) IV over not less than three minutes immediately to be followed by 10g (20 ml of 50%) IM 5g in each buttock. If convulsions persists-after 15 minutes 2g(10 ml of 20%) is given over 2 minutes. If woman is large 4g is given Maintenance Maintenance dose: 5g(10 ml of 50%)is given e v e r y 4 h o u r s a t alternate sites after assuring -presence of knee reflex -respiratory rate >14/min -urine output > 100 ml 02/12/16 KSOGA

20 MgSO 4 DOSAGE SCHEDULE Loading dose - slow IV 4 gms of MgSO4 given over 10 minutes. Add 8ml of 50% MgSO4 to 12ml saline. (4G in 20ml) Beware Rapid injection can cause respiratory failure death 02/12/16 KSOGA

21 LOADING DOSE IM - 5G of 50% MgSO4 =10ml of 50% MgSO4 each buttock 10 grams Continue 24 hours Last convulsion Or DELIVERY 02/12/16 KSOGA

22 MAINTENANCE IM. IM - - 5G of 50% MgSO4 =10ml of 50% MgSO4 every 4 hrs alternate buttocks TOTAL OF 44 GRAMS 02/12/16 KSOGA

23 CLOSE MONITORING MONITOR STOP INFUSION Urinary output < 30ml/hr in the preceding 4 hrs. Patellar Reflex Disappear Respiratory rate < 16 breaths/min No need to monitor MgSO4 levels Antidote: Patellar reflexes absent (after being present) Res. Rate <16/min. Administer: Calcium gluconate 1G IV over 10 mts. (10ml of 10 % solution) 02/12/16 KSOGA

24 UNCONTROLLED CONVULSIONS Loading dose Wait for 15mts if convulsions do not stop Rpt. 2 gm of MgSO4 [4ml of 50% MgSO4 + 6ml of saline] Slow IV over 10 mts. RECURRENCE: seizures recur while on maintenance dose use the same regimen. 02/12/16 KSOGA

25 Uncontrolled CONVULSIONS STATUS ECLAMPTICUS Initial dose : 1gm IV slow infusion over 20minutes followed by 100mg every 6 th hourly for next 24 hours LUCAS REGIMEN - PHENYTOIN 02/12/16 KSOGA

26 RECURRENCE???? UNCONTROLLED HYPERTENSION (MULTIFACTORIAL) 02/12/16 KSOGA

27 Blood Pressure > 160 / 110 mm Hg l CONTROL l HYPERTENSION I. V. LABETALOL l strict monitoring 02/12/16 NHBPEP (2000) KSOGA

28 LABETALOL 10mg IV 10 mts if BP > 170 /110 20mg IV mts if BP > 170 /110 40mg IV Max- 220 mgs 02/12/16 KSOGA

29 NO PLACE for CONTINUATION PLAN the DELIVERY DELIVERY IN THE BEST WAY 02/12/16 KSOGA

30 02/12/16 KSOGA

31 C C C CONTROVERSY CONFUSION CLARITY 02/12/16 KSOGA

32 CONTROVERSY WHICH ANTIVONVULSANT..? 02/12/16 KSOGA

33 Best Anticonvulsive is the drug of choice for routine anti- convulsant management of women with eclampsia, rather than diazepam or phenytoin. Evidence from the Collaborative Eclampsia Trial. l Lancet Jun (8963). pp /12/16 KSOGA

34 CONFUSION WHICH REGIMEN..? 02/12/16 KSOGA

35 DIFFERENT MgSO4 REGIMENS Ø Eastman. Ø Pritchard. Ø Chesley & Teppers. Ø Hall, Anderson, Harbert. Ø Flowers. Ø Zuspan. Ø Cruik Shant. Ø Sibai. Ø Sardesai Ø Leens. etc TOXICITY 02/12/16 KSOGA

36 CONVENTIONAL WESTERN REGIMENS: can not be given outside l units Longer duration High dose obstetric care Costant supervision Cost in effective Conv.mgso4 regimen Requires Ins.therapy Trained Health prof More side effects 02/12/16 KSOGA

37 MgSO4 Regimens VIMS classification l HIGH dose regimens: Pritchard s, loading dose > 10 gm Lucas etc. l LOW dose regimens: loading dose < 10 gm Zuspan, Suman Sardesai etc. l SINGLE DOSE Regimens: VIMS Regimen Sokoto regimen 02/12/16 KSOGA Joshi Suyajna D. Hypertensive Disorders In Pregnancy

38 Pritchard s Regimen. 54 years old! l Pritchard JA. The use of the magnesium ion in the management of eclamptogenic toxemias. l Surg Gynecol Obstet. 1955; 100: /12/16 KSOGA

39 LOW Dose regimens. loading Zuspan 4g IV over 5-10 minutes Charles Flowers 4g IV in 250 ml of 5% D maintenance 1-2g/hr as IV infusion 5g every4-6 hrs as IM Chesley -Tepper 5g every 4 th hour given as IM 5g every 4 th hour given as IM Eastman 5g every 4 th hour given as IM 5g every 4 th hour given as IM 02/12/16 KSOGA

40 l Low Dose.Steady Reduction in dose.indian Scenario SUB-OPTIMAL DOSE MgSO4..2 gram IM MgSO4 2 gram IV Sardesai Suman, Maira Shivanjali, Patil Ajit, Patil uday. Low dose magnesium sulphate for eclampsia and imminent eclampsia: regimen tailored for tropical women. J Obstet Gynaecol Ind. 2003; 53: Mahajan NN, Thomas A, Soni RN, Gaikwad NL, Jain SM:'Padhar Regime' - A Low-Dose Magnesium Sulphate Treatment for Eclampsia. Gynecol Obstet Invest 2009; 67:20-24 Joydeb Roy Chowdhury, Snehamay Chaudhuri, Nabendu Bhattacharyya, Pranab Kumar Biswas and Madhabi Panpalia. Comparison of intramuscular magnesium sulfate with low dose intravenous magnesium sulfate regimen for treatment of eclampsia, J Obstet Gynecol Res 02/12/16 KSOGA Feb; 35 (1):

41 SINGLE DOSE REGIMENS JOSHI SUYAJNA D VIMS REGIMEN 4 gm IV + 4 gm IM SOKOTO ULTRA regimen: ONLY LOADING DOSE OF PRITCHARD S 02/12/16 KSOGA

42 CLARITY REGIMEN SUITABLE FOR OUR SETUP: 1. NO FEAR OF TOXICITY 2. PRE- LOADED SYNRINGES 3. EASY AVAILABILITY EVERY WHERE 4. CAN BE ADMINISTERED ANY WHERE CAN BE ADMINISTERED ANY WHERE 02/12/16 KSOGA

43 Why Magnesium Sulphate? n 1. To abort an attack of convulsion n 2. To prevent immediate recurrence of convulsions n 3. To gain time for the ANTIHYPERTENSIVE to act ONE ADEQUATE DOSE is sufficient 02/12/16 KSOGA

44 MgSO4 MUST BE GIVEN As early as possible (with- in 2 hours of convulsions) 02/12/16 KSOGA

45 Loading Dose.? SAFEST DOSE NOT MORE THAN 14 Grams 8-10 MgSO4 NOT LESS THAN 8 Grams gms. Therapeutic concentration of NO TOXICITY 4 to 6 meq/l 02/12/16 KSOGA

46 MgSO4. SAFE? NO n FDA Warning: Don t Use Magnesium Sulfate to Stop Pre-term Labor FDA has changed the Pregnancy Category n By Becky Ellis, Editorial Director, ObGyn.net of June 6, 2013 magnesium sulfate(drug information on magnesium sulfate) from A to D, indicating that there is positive evidence of human fetal risk when the drug is used during pregnancy 02/12/16 KSOGA

47 What is the problem with PRITCHARD S REGIMEN 1. Loading dose is MORE than necessary 2. Maintenance dose is NOT necessary 02/12/16 KSOGA

48 What is the problem with LOW DOSE REGIMEN eg. ZUSPAN s 1. Loading dose is NOT sufficient 2. Maintenance dose is NOT necessary 02/12/16 KSOGA

49 CONTROVERSY ALL ECLAMPSIA PATIENTS MUST BE TREATED ONLY AT HDU 02/12/16 KSOGA

50 CONFUSION NO HDU WITH IN kms. DISTRICT HOSPITAL WITH IN 5 kms 02/12/16 KSOGA

51 CLARITY MILD ECLAMPSIA MULTI SPECIALITY HOSPITAL OBSTETRICIAN, ANAESTHETIST NEONATOLOGIST, PHYSICIAN SEVERE ECLAMPSIA STABILIZE TRANSFER TO HDU 02/12/16 KSOGA

52 MODIFIED PROTOCOL INITIAL MANAGEMENT MgSO4 and Nifedipine MILD ECLAMPSIA DISTRICT HOSPITAL SEVERE ECLAMPSIA PROPER TRANSPORT TO TERTIARY CARE CENTRE 02/12/16 KSOGA

53 WHY HDU? SEVERE ECLAMPSIA = COMPLICATIONS MATERNAL MORTALITY DIRECTLY PROPORTIONAL TO HIGH MAP (> 125 mm Hg) Multi- organ involvement 02/12/16 KSOGA

54 Maternal mortality vs MAP MATERNAL MORTALITY MAP (mmhg) 3 CASES 120 to CASES > 130 VIMS OBG /12/16 KSOGA

55 Maternal complications vs MAP Joshi Suyajna D. et al. SINGLE DOSE MGSO4 REGIMEN FOR ECLAMPSIA - A SAFE 02/12/16 KSOGA MOTHERHOOD INITIATIVE.Journal of Clinical and Diagnostic Research, [cited:2013 Jun 28]

56 Early and PROPER referral is the cornerstone in the success of saving the mother in eclampsia. Adetoro reported 14.4% of maternal mortality..referral KSOGA 2013 without treatment. 02/12/16 56

57 FREE SEIZURE - TRANSPORTATION 02/12/16 KSOGA MgSO4 before referral

58 The convulsion-treatment interval. MgSO4 before referral and after reaching the referral centre-?????? 87.5% of the patients did not receive any treatment before reaching the referral centre. VIMS % received MgSO4 before admission NO MATERNAL DEATHS 02/12/16 KSOGA

59 TAKE HOME MESSAGE.. Rushed delivery in an unstable patient is dangerous Treat with anticonvulsants & antihypertensives Deliver Transfer if necessary 02/12/16 KSOGA

60 SHIFT OF IMPORTANCE Total no. Deliveries Total no. of Maternal Deaths PPH APH Eclampsia ANTICONVULSANT 02/12/16 KSOGA ANTIHYPERTENSIVE

61 CHANGE IN APPROACH Till June 30th NO OF DELIVERIES NO OF ECLAMPSIA MATERNAL DEATHS 9 1 ANTICONVULSIVE ANTIHYPERTENSIVE DELIVERY 61

62 THANKFUL TO. JOSHI SUYAJNA D. 02/12/16 KSOGA

63 Sibai B M. Eclampsia Maternal-perinatal outcome in 254 consecutive cases. Am J Obstet Gynecol 1990; 163: 1049 Sibai recommends that the patient should be stabilized regarding blood pressure & control of convulsion before transport and the patient should be sent in an ambulance with medical personnel in attendance. 02/12/16 KSOGA

64 INVESTIGATIONS l Platelet count < 1 lakh/cu mm HELLP PROFILE l DIC PROFILE: Fibrinogen 02/12/16 KSOGA

65 Suman Sardesai. In 1997 Suman Sardesai from V.M. Medical College Sholapur Loading dose Maintenance dose 4g MgSO4 given as IV or IM 2g given as IV /IM every 3hrs. If convulsions recurred after 15 min additional dose of MgSo4 given 02/12/16 KSOGA

66 SECOND LINE ANTI CONVULSIVE Loading dose DIAZEPAM 10mg over 2 mts Convulsions recur Diazepam 10 mg over 2mts Maintenance Dose Max dose-100 mg in 24hrs Use Diazepam When ANTIHYPERTENSIVE -- MgSO4 not available -- Toxicity Diazepam the risk of neonatal respiratory depression 02/12/16 KSOGA

67 ANTIHYPERTENSIVES C. Nifedipine 5mg ONLY Oral After 10 mts if BP> /110, repeat same dose. Tab Nifedipine Slow release mg every 8 hrs. Beware additive effect with MgSO4 but not contra indicated 02/12/16 KSOGA

68 ANTIHYPERTENSIVES Inj. Hydralazine 5mg IV slowly over 3-4 mts Rpt dose if needed in 20 mts Maintenance dose - 20 mg in 50 ml of saline 1mg/hr, by 1mg every ½ hour. 02/12/16 KSOGA

69 SHIFTING TO TERTIARY CARE CENTER Indications Rural area Regardless of the care available shift Urban area Comprehensive emergency care not available Patients with severe PE / eclampsia/ recurrent convulsions Complications of preeclampsia HELLP, ARF Pulmonary oedema, How to shift Shift only after stabilizing with 02/12/16 KSOGA primary treatment

70 SHIFTING TO TERTIARY CARE CENTER Shift in an ambulance with medical personnel accompanying Maintain airway oxygen availability Maintain IV access Pre loaded syringe - MgSO 4 2gm in 10ml (4ml-50% MgSO 4 + 6ml Saline) or Diazepam (10mg)Cunningham FG, 02/12/16 KSOGA Leveno KJ, Hauth JC, Rouse DJ, Spong CY,

71 Eclampsia l Eclampsia : preeclampsia complicated by generalized tonic-clonic convulsions l Major complications Placental abruption (10%) Neurological deficits (7%) Aspiration pneumonia (7%) Pulmonary edema (5%) Cardiopulmonary arrest (4%) Acute renal failure (4%) Maternal death (1%) 02/12/16 KSOGA

72 02/12/16 KSOGA

73 SAFETY LEVELS OF MgSO4 Eclamptic convulsions are prevented by plasma magnesium levels maintained at 4 to 7 meq/l at 4.8 to 8.4 mg/dl at 2.0 to 3.5 mmol/l n Magnesium sulfate is not given to treat hypertension n 8 grams of MgSO4 achieves 6 to 8 meq/l 02/12/16 KSOGA

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