Standard Management protocol for ECLAMPSIA

KSOGA 2013 02/12/16 1

RESOURCE – RESTRICTED SETTINGS

PROTOCOLS

MEDICINE is an imperfect science, an

enterprise of constantly changing knowledge, uncertain information,

fallible individuals,

at the same time “ lives on the line"

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POOR RESOURCE SETTINGS

RESTRICTED - RESOURCE SETTINGS

l  RESTRICTED RESOURCE SETTINGS

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UNEQUAL EQUATIONS

v 27,000,000 DELIVERIES PER YEAR l 27000 OBSTETRICIANS

v 1 OBSTETRICAN FOR 1000 DELIVERIES

l 50 % UNATTENDED HOME DELIVERIES

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RESTRICTED- RESOURCES

l Resources available l Usage restricted

1. suboptimal usage of infrastructure 2. suboptimal usage of human resource

02/12/16 KSOGA 2013 5

Global Scenario Maternal Mortality – 2010

24.8

14.9

12.96.912.9

7.9

19.8

Hemorrhage 24.8%

Infection 14.9%

Eclampsia 12.9%

Obstructed Labor6.9%Unsafe Abortion12.9%Other Direct Causes7.9%Indirect Causes19.8%Annually,  2,87,000    women  die  of  

pregnancy  related  complica9ons    

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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):90-4. 02/12/16 7 KSOGA 2013

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 8 KSOGA 2013

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 2013 9

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 10 KSOGA 2013

Three stage management strategy for management of eclampsia-

1 •  Primary management,at or near the place

of convulsion.

2 •  ‘Seizure Free Transportation’ of the patient

3 •  Tertiary level management in •  DISTRICT HOSPITAL or HDU

NEWER THINKING

KSOGA 2013

11

BP may be normal !

Treat all women with convulsions in pregnancy as

eclampsia until proven otherwise.

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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

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14

HDU

Standard Management Protocol

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

Standard Management Protocol

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DO NOT LEAVE

THE PATIENT ALONE

PLACE IN LEFT LATERAL

POSITION

CALL FOR HELP

A B C

PROTOCOL

ANTICONVULSIVE MgSO4

ANTIHYPERTENSIVE I.V. LABETALOL

DO NOT CONCENTRATE ONLY ON ANTICONVULSIVE REGIMENS.

02/12/16 KSOGA 2013 17

PROTOCOL DO NOT CONCENTRATE ONLY ON ANTICONVULSIVE REGIMENS.

ANTICONVULSIVE MgSo4

ANTIHYPERTENSIVE I.V LABETALOL

PRITCHARD’S REGIMEN

Loading   Maintenance  

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 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

 

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CONTROL

CONVULSIONS

MgSO4 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 2013 20

LOADING DOSE

IM - 5G of 50% MgSO4 =10ml of 50% MgSO4 each buttock

10 grams

Continue 24 hours Last convulsion

Or DELIVERY

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MAINTENANCE IM….

IM - - 5G of 50% MgSO4 =10ml of 50% MgSO4

every 4 hrs

alternate buttocks

TOTAL OF 44 GRAMS

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CLOSE MONITORING

§  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)

MONITOR STOP INFUSION

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Wait for 15mts

UNCONTROLLED CONVULSIONS

RECURRENCE: seizures recur while on maintenance dose use the same regimen.

Loading dose

if convulsions do not stop

Rpt. 2 gm of MgSO4 [4ml of 50% MgSO4 + 6ml of saline] Slow IV over 10 mts.

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STATUS ECLAMPTICUS

► Initial dose : 1gm IV slow infusion ►  over 20minutes ►  followed by 100mg every ►  6th hourly for next 24 hours

LUCAS REGIMEN - PHENYTOIN

Uncontrolled CONVULSIONS

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RECURRENCE… ????

UNCONTROLLED HYPERTENSION

(MULTIFACTORIAL) 02/12/16 KSOGA 2013 26

Blood Pressure > 160 / 110 mm Hg

l 

l  I. V. LABETALOL

l  strict monitoring

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CONTROL

HYPERTENSION

NHBPEP (2000) 02/12/16

LABETALOL

10mg IV

20mg IV

40mg IV

10 mts if BP > 170 /110

Max- 220 mgs

10 mts if BP > 170 /110

80

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NO PLACE for CONTINUATION

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DELIVERY

“PLAN the DELIVERY

IN THE BEST WAY”

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CONTROVERSY

CONFUSION

CLARITY

C C C

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CONTROVERSY

WHICH ANTIVONVULSANT..?

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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. 1995 Jun 10. 345(8963). pp 1455-1463.

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CONFUSION

WHICH REGIMEN..?

02/12/16 KSOGA 2013 34

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 02/12/16 35

TOXICITY

KSOGA 2013

CONVENTIONAL WESTERN REGIMENS: can not be given outside l  ‘obstetric care units’

KSOGA 2013

Longer duration

Cost in effective

Trained Health prof

More side effects

Requires Ins.therapy

Costant supervision

High dose

Conv.mgso4 regimen

02/12/16 36

MgSO4 Regimens… VIMS classification l HIGH dose regimens: Pritchard’s,

loading dose > 10 gm Lucas etc.

l LOW dose regimens: Zuspan, Suman loading dose < 10 gm Sardesai etc.

l SINGLE DOSE Regimens: VIMS Regimen Sokoto regimen

02/12/16 37 Joshi Suyajna D. ‘Hypertensive Disorders In Pregnancy’ - 2009 KSOGA 2013

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: 131–140

KSOGA 2013 02/12/16 38

LOW Dose regimens….

loading maintenance Zuspan 4g IV over 5-10

minutes 1-2g/hr as IV infusion

Charles Flowers 4g IV in 250 ml of 5% D

5g every4-6 hrs as IM

Chesley -Tepper 5g every 4th hour given as IM

5g every 4th hour given as IM

Eastman 5g every 4th hour given as IM

5g every 4th hour given as IM

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l  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: 546-50. 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

2009 Feb; 35 (1): 119 -125

Low…Dose….Steady Reduction in dose….Indian Scenario… SUB-OPTIMAL DOSE

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SINGLE DOSE REGIMENS

JOSHI SUYAJNA D. 1998

‘VIMS REGIMEN’ 4 gm IV + 4 gm IM

SOKOTO ULTRA regimen: ONLY LOADING DOSE OF PRITCHARD’S

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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

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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

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MgSO4

MUST BE

GIVEN As early as possible

(with- in 2 hours of convulsions)

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Loading Dose…. ?

NOT MORE THAN 14 Grams

NOT LESS THAN 8 Grams

Therapeutic concentration of 4 to 6 mEq/L

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SAFEST DOSE MgSO4 8-10 gms.

NO TOXICITY KSOGA 2013

MgSO4…. SAFE…?

n  FDA Warning: Don’t Use Magnesium Sulfate to Stop Pre-term Labor

n  By Becky Ellis, Editorial Director, ObGyn.net | June 6, 2013

02/12/16 46

NO

FDA has changed the Pregnancy Category of 

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 KSOGA 2013

What is the problem with PRITCHARD’S REGIMEN

1. Loading dose is MORE than necessary

2. Maintenance dose is NOT necessary

02/12/16 47 KSOGA 2013

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 48 KSOGA 2013

CONTROVERSY

ALL

ECLAMPSIA PATIENTS MUST BE TREATED

ONLY

AT ‘HDU’ 02/12/16 KSOGA 2013 49

CONFUSION

NO ‘HDU’ WITH IN

50 – 100 kms.

DISTRICT HOSPITAL WITH IN 5 kms

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CLARITY

MILD ECLAMPSIA MULTI SPECIALITY HOSPITAL

OBSTETRICIAN, ANAESTHETIST NEONATOLOGIST, PHYSICIAN

SEVERE ECLAMPSIA

STABILIZE…… TRANSFER TO ‘HDU’

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MODIFIED PROTOCOL

INITIAL MANAGEMENT MgSO4 and Nifedipine

MILD ECLAMPSIA

DISTRICT HOSPITAL

SEVERE ECLAMPSIA PROPER TRANSPORT TO TERTIARY

CARE CENTRE 02/12/16 KSOGA 2013 52

WHY ‘HDU’…?

SEVERE ECLAMPSIA = COMPLICATIONS MATERNAL MORTALITY

DIRECTLY PROPORTIONAL TO HIGH ‘MAP’ (> 125 mm Hg)

Multi- organ involvement

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Maternal mortality vs MAP

MATERNAL MORTALITY MAP (mmHg)

3 CASES 120 to 130

6 CASES > 130

VIMS – OBG 2012

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Maternal complications vs MAP

Joshi Suyajna D. et al .„SINGLE DOSE MGSO4 REGIMEN‟ FOR ECLAMPSIA - A SAFE MOTHERHOOD INITIATIVE.Journal of Clinical and Diagnostic Research , 2013 05 [cited:2013 Jun

28] 5 868 - 872 02/12/16 KSOGA 2013 55

Early and –’PROPER” referral

is the cornerstone in the success of saving the mother

in eclampsia.

Adetoro reported 14.4% of maternal mortality..referral without treatment….

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‘

SEIZURE -FREE TRANSPORTATION

02/12/16 57 KSOGA 2013 MgSO4 before referral

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- 2003- 2007

2012- 45% received MgSO4

before admission – NO MATERNAL DEATHS

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TAKE HOME MESSAGE..

Treat with

anticonvulsants &

antihypertensives

Deliver

Rushed delivery in an unstable patient is dangerous

Transfer if necessary

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SHIFT OF IMPORTANCE 2009 2010 2011 2012 2013

Total no. Deliveries

4766 4459 5013 6435 3063

Total no. of Maternal Deaths

35 34 33 29 17

PPH 6 7 5 5 4

APH 3 3 4 3 2

Eclampsia 8 9 7 9 1

02/12/16 60 ANTICONVULSANT ANTIHYPERTENSIVE

KSOGA 2013

DELIVERY

CHANGE IN APPROACH

2012 2013 Till June 30th

NO OF DELIVERIES 6435 3063

NO OF ECLAMPSIA 206 96 MATERNAL DEATHS 9 1

ANTIHYPERTENSIVE ANTICONVULSIVE

61

THANKFUL TO….

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JOSHI SUYAJNA D. www.suyajna.com

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.

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INVESTIGATIONS

l Platelet count < 1 lakh/cu mm – HELLP PROFILE

l DIC PROFILE: Fibrinogen 02/12/16 KSOGA 2013 64

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 65 KSOGA 2013

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 2013 66

ANTIHYPERTENSIVES

C. Nifedipine 5mg ONLY Oral

After 10 mts if BP> /110, repeat same dose.

Tab Nifedipine Slow release 10-20 mg every 8 hrs.

Beware – additive effect with MgSO4

but not contra indicated 02/12/16 KSOGA 2013 67

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.

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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 primary treatment 02/12/16 KSOGA 2013 69

SHIFTING TO TERTIARY CARE CENTER

§  Shift in an ambulance with medical personnel

accompanying

§  Maintain airway – oxygen availability

§  Maintain IV access

§  Pre loaded syringe - MgSO4 2gm in 10ml

(4ml-50% MgSO4 + 6ml Saline)

or

Diazepam (10mg)Cunningham FG,

Leveno KJ, Hauth JC, Rouse DJ, Spong CY,

WILLIAM’S OBSTETRICS, 23rd edition, The

McGeaw Hill Companies, Inc. 2010, Chapter 34,

735-746

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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%)

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SAFETY LEVELS OF MgSO4

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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

KSOGA 2013