CLINICAL GUIDELINE FOR THE MANAGEMENT OF A WOMAN WITH ECLAMPSIA AND/OR SEVERE PRE ECLAMPSIA 1.

Aim/Purpose of this Guideline

1.1. This document gives guidance to obstetricians, anesthetists, midwives and delivery suite nurses on the recognition and management of eclampsia and sever pre eclampsia

2. The Guidance
2.1. Hypertensive disorders during pregnancy occur in women with pre-existing primary or secondary chronic hypertension, and in women who develop new-onset hypertension in the second half of pregnancy. Hypertensive disorders complicate up to 7% of all pregnancies and continue to be major cause of maternal death in the UK1. Pre-eclampsia is new hypertension presenting after 20 weeks of pregnancy with significant proteinuria. Severe pre-eclampsia is pre-eclampsia with severe hypertension and/or with symptoms, and/or biochemical and/or haematological impairment. Eclampsia is a convulsive condition associated with pre-eclampsia 2.2. Indications for transfer to DELIVERY SUITE: Uncontrollable BP Eclampsia Severe maternal symptoms Fetal compromise Renal failure 2.3. Treatment for severe pre eclampsia/eclampsia on delivery suite The following clinicians should be informed, by the delivery suite coordinator Obstetric Registrar Obstetric consultant on call Anaesthetist on call for Delivery Suite . The decision for and mode of delivery will depend on the severity of the condition. The initial aim is to stabilise the woman. Involve the obstetric anaesthetic team at the earliest opportunity and consider elective placement of an epidural catheter. 2.4. Maternal and fetal Monitoring/assessment Midwifery A MEOWS/HDU Chart must be used. Half hourly blood pressure, pulse, respiratory rate and pulse oximetry 4 hourly temperature Strict fluid balance, with hourly urine output Fetal monitoring: All women should have electronic fetal monitoring on admission to delivery suite, and should be continually monitored unless a decision made by a senior obstetrician to discontinue.
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Women in labour with severe pre-eclampsia should have continuous electronic fetal monitoring.

Obstetric The obstetric registrar will review the woman on admission to delivery suite and will document a management plan including the timing of the next review. Initially the review should be at least hourly and once stabilised review should be at least every four hourly. At each review the following should be undertaken and documented in the health records. Change in symptoms, especially confusion and persistent visual disturbance Observations blood pressure, maternal heart rate, respiratory rate and Oxygen saturation Full chest examination, including jugular venous pressure (JVP) measurement Level of consciousness, reflexes and clonus Fluid balance Six-hourly blood investigations (full blood count, platelets, clotting, urea and electrolytes, liver function tests and uric acid) unless otherwise indicated Fetal condition as based on the electronic fetal monitoring If conservative management is planned then further assessment of the fetus with ultrasound measurements of fetal size, umbilical artery Doppler and liquor volume should be undertaken. 2.5. Blood pressure control Aim to keep BP <150/100 mmHg. Oral antihypertensives should be used in the initiate treatment however intravenous antihypertensives will be needed as well if BP doesnt respond to oral therapy or if severe hypertension e.g. BP>170/110. The plan for blood pressure control should be documented in the womans notes.

Oral preparations
Recommended oral preparations for the acute management of hypertension 1. Nifedipine: This acts as a direct smooth muscle dilator. Two nifedipine preparations are useful in this situation. a. Nifedipine capsules (5mg). Acts within 10-15 minutes. Treatment should commence with this preparation. b. Adalat Retard (slow release tablets, 20 mg).Acts within 60 minutes. Sustained action .Useful for continuing treatment. NOTE: Never use sublingual crush to lower BP. The sudden fall can cause severe fetal compromise Nifedipine regimen Nifedipine 5mg orally stat Repeat at 20 minute intervals until BP controlled, to a maximum of 4 doses Start Adalat Retard once target BP reached If non-responsive, consider hydrallazine
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OR 2. Labetalol 200mg (oral) stat (caution in asthma) Check BP every 5 minutes for 15 minutes: If BP <150/100 mm Hg commence maintenance oral therapy. If BP >150/100 mm Hg commence intravenous treatment

Intravenous treatment
If BP control requires intravenous treatment then the level of care should be increased to level 2 care and a high dependency chart (HDU) chart commenced. Recommended IV treatment for BP control: 1. Hydralazine This acts as a vasodilator, expanding intravascular volume. In an undelivered patient, Volume expansion of up to 500ml Hartmanns should be considered prior to administration of hydralazine. Hydralazine bolus: 5 mgs over a period of 10 minutes slow intravenous administration, Recheck BP every 5 minutes for 20 minutes. If BP not controlled after 20 minutes, can repeat 5mg bolus at 20 minute intervals to a maximum of 4 doses. Hydralazine infusion: Hydralazine is incompatible with dextrose. It should be infused via a syringe driver as follows: Mix 50 mg of Hydralazine with Normal Saline to make up to 50 ml, i.e. 1 mg/ml. START infusion at 5 mg/hr The rate can be doubled every 30 minutes, titrate according to response Maximum rate is 40 mg/hr The BP should be taken manually every 5 minutes Aim for systolic BP < 160 & diastolic BP 90 - 100 mmHg Thereafter the BP recordings should be repeated every 30 minutes if stable The blood pressure should be lowered slowly as rapid alterations of the blood pressure can cause cerebral hypoxia The fetal heart rate should be continuously monitored as Hydralazine can cause fetal distress 2. Labetalol (caution in asthma) Labetalol bolus 20 mg over a period of 5 minutes slow intravenous administration, Recheck BP every 5 minutes for 20 minutes If BP not controlled after 20 minutes, give 40 mg, 40 mg, 80 mg at 10 minute intervals up to a maximum dose of 180 mg Labetalol Infusion Draw up 40mls Labetalol (5mg/ml) Start infusion at 20mg/hr (ie 4 ml/hr)
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double every 30 minutes until a satisfactory response, (BP <150/100 mmHg) or to a maximum infusion rate of 160mg/hour

2.6. Fluid balance It is essential that fluid balance is closely monitored2 Total fluid input of 80 mls/hr, except for acute replacement of blood loss Infused drugs should be administered in concentrated solutions Insert Foley catheter and assess fluid output hourly If urine output <20 mls/hour request review by experienced obstetrician and assessment of fluid balance If after 4 hours urine output <80 mls inform experienced obstetrician to review woman. Manage as per flow chart on page 5 If anuria (no urine output over 1 hour) at any point request review by experienced obstetrician and assessment of fluid balance Management plan should be documented in the womans notes. Fluid Management Regimen for Severe Pre-Eclampsia/Eclampsia 1. Intravascular volume expansion3,4 Initial volume expansion should be given only after discussion at consultant level and in the following situations: Indications: in conjunction with vasodilator therapy for acute blood pressure control acute symptomatic liver involvement, oliguria fetal distress5 (without delaying delivery if mother sufficiently stable) Contraindications: IV fluids have already been administered, there is cardiac disease or there are signs of pulmonary oedema / fluid overload Colloids should NOT be used for intravascular volume expansion. Use Hartmanns 500ml over 1 hour with continuous oxygen saturation monitoring. Any further fluid administration should be very cautious because the pre-eclamptic patient is very readily overloaded. Pulmonary oedema kills but oliguria and renal tubular acidosis does not. Fluid should be given according to the protocol flow chart below.

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2.7. Maintenance Fluids

80 ml Hartmanns / hour NB. Reduce if other infusions e.g. Mg SO4 (80 ml TOTAL fluid / hour = maintenance

Urine output >80ml / 4 hrs

Urine output <80 ml / 4 hrs

250 ml Hartmans over 15 mins (if O2 sats and chest exam are OK)

Urine output >20 ml over next hour Continue maintenance fluids

Urine output remains <20 ml over next h Repeat 250 ml Hartmans over 15 mins (ONLY if O2 sats and chest exam are OK)

If <20ml/hr to discuss with consultant anaesthetist. To consider CVP to guide further fluid management

If oliguria persists to repeat U &Es and consider Nephrology

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2.8. Severe Pre-eclampsia, Eclampsia & Magnesium Sulphate Magnesium sulphate should be used for women with eclampsia and considered in severe pre-eclampsia6, 7. Discuss all cases with the on-call Consultant. Indications 1. Eclampsia- Magnesium sulphate rarely required to stop fit usually self limiting 2. Any woman with severe pre-eclampsia where the decision to deliver has been made and where there is one other of the following criteria Hypertension with diastolic BP 110 mm Hg or systolic BP 170 mm Hg on two occasions and proteinuria 3+ Hypertension with diastolic BP 100mg Hg or systolic BP 150 mm Hg on two occasions and proteinuria 2+ (0.3 g/day) and at least two of the following: a. b. c. Epigastric pain, vomiting, liver tenderness, Headache, visual disturbance, Clonus ( > 3 beats) Haematological or biochemical evidence of developing HELLP syndrome: platelet count < 100, ALT (alanine aminotransferase) >50 iu/l Creatinine > 100 or creatinine clearance <80

d.

Clinical discretion should be used to include women who present with atypical symptoms Magnesium Sulphate Regimen: Magnesium Sulphate (MgSO4) is the treatment of choice for the first fit8. Loading dose: Magnesium sulphate 4 grams 8mls of MgSO4 (50%) diluted with 12mls Normal Saline (0.9%) = Total 20mls Give IV over 20 minutes using syringe driver rate of 60 mls/hour Maintenance dose: Magnesium sulphate 1 gram per hour 20mls MgSO4 (10 gms) diluted with 30mls Normal Saline (0.9%) = Total 50mls Give IV using syringe driver at rate of 5mls/hour Recurrent seizures whilst on magnesium Further bolus of 4mls MgSO4 (2 gms) diluted with 6mls Normal Saline (0.9%) Give IV over 5 minutes If possible take blood for Magnesium levels before bolus Notify obstetric and anaesthetic consultants If further seizures occur Inform Consultants Consider other causes of fits including intracranial haemorrhage Consider using other drugs, including general anaesthesia
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Management of a woman receiving magnesium sulphate Experience from the Collaborative Eclampsia and Magpie Trials indicates that magnesium sulphate (according to the above regime) can be used safely without the need to monitor any levels. Magnesium toxicity causes loss of tendon reflexes, followed by respiratory depression and ultimately, respiratory arrest. Toxic levels are unlikely to be reached with a maintenance dose of 1 gram per hour and urine output of > 100mls/4 hours5. Monitoring of a woman receiving magnesium sulphate (MgSO4) 1. Deep tendon reflexes hourly (Biceps tendon if epidural in situ) If loss of reflexes - STOP infusion and send levels Recommence infusion if level < 4mmol/l or reflexes return at 0.5gms per hour 2. Hourly urine measurements If oliguria (urine output <20 mls for >4 hrs) or urea > 10, magnesium levels should be taken 6 hourly (therapeutic range 2-4 mmol/l). Magnesium levels > 4mmol/l - STOP infusion and seek consultant opinion 3. Continuous pulse oximetry Oxygen saturation < 95% in air should raise concern (magnesium toxicity, pulmonary oedema) Cardiopulmonary arrest Stop magnesium infusion Start basic life support Give 1 gram calcium gluconate IV (10mls 10% solution) over 10 minutes Intubate early and ventilate until respirations resume

2.9. Management of blood clotting 9 If the platelet count is less than 50 x 10 /l a platelet transfusion should be considered and if for caesarean section this should be in consultation with the consultant haematologist 9 A platelet count less than 100 x 10 /l (or rapidly falling count) warrants a 9 baseline clotting screen. Consult Haematologist early where there is clinical or haematological evidence of coagulopathy. If a platelet transfusion is indicated as above, one adult dose of platelets should be administered prior to incision, plus a further adult dose at uterine closure. If the woman is bleeding, check fibrinogen as a low fibrinogen is an 10 important indicator of Disseminated Intravascular Coagulation (DIC). Cryoprecipitate should be given if bleeding and fibrinogen is less than 1.0g/l.
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Fresh frozen plasma should be used to correct a prolonged PT or APTT if bleeding is not controlled. 2.10. Delivery Planning The decision to deliver should not be made until the woman is stable, blood pressure control is achieved and appropriate senior personnel are present, even for fetal concerns. If there are fetal concerns ensure that the neonatal unit have been informed to enable them to prepare for the baby. If the fetus is less than 34 weeks of gestation and delivery can be deferred, corticosteroids should be given, although after 24 hours the benefits of conservative management should be reassessed. Conservative management at very early gestations may improve perinatal outcome but must be carefully balanced with maternal wellbeing. The mode of delivery should be determined after considering the presentation of the fetus and the fetal condition, together with the likelihood of success of induction of labour after assessment of the cervix. The third stage should be managed with syntocinon/carbetocin. Syntometrine/ergometrine should not be given, as this can further increase the blood pressure. 2.11. Management post delivery After delivery the woman must remain on DELIVERY SUITE for a minimum of eight hours. The decision to transfer to the wards must be made by a senior Obstetrician. If magnesium sulphate given, this needs to continue for at least 24 hours post delivery and the woman will remain on delivery suite during this time. 2.12. Post Natal Management All the patients who had severe preclampsia/eclampsia should be reviewed by a doctor within 24 hours of transfer to Wheal Fortune To stay in the Wheal Fortune for at least 3 days unless discharged earlier by senior obstetrician. All women with severe pre eclampsia or eclampsia should be given an appointment for the consultant ANC in 4 weeks. It is the responsibility of the discharging doctor to ensure this appointment is arranged. Ante natal clinic appointment is not appropriate if pregnancy resulted in an intrauterine death (IUD), in this case individualized followed up will be arranged by the named consultant. . BP must have been <140/90 for at least 24 hours prior to discharge unless decision for discharge made by a senior obstetrician. Most women should continue on their antihypertensive therapy particularly if needed pre delivery. They should be advised to continue this until reviewed in the consultant clinic. Women in whom serum biochemistry is still deranged on discharge should be given a form and instructions to have the bloods repeated prior to the consultant appointment. CMW to be informed of discharge and to monitor BP daily for first week. Women will be seen in the consultant clinic in 4 weeks to debrief clinical events and discuss implications for future pregnancies. If on antihypertensives then these should be reviewed as to the need to continue. The blood results should Page 8 of 15

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also be reviewed. A letter should be written to the GP at this appointment with clear instructions regarding the antihypertensive therapy and BP monitoring +/investigation of proteinuria/ deranged biochemistry if persistent. Consideration of pre conceptual counseling for the next pregnancy

2.13. Reference: 1. Statistical Bulletin, NHS Maternity Statistics, England 1998-99 and 2000-01. Department of Health, London. April 2002. 2. Management of Eclampsia: Clinical Guideline. RCOG, 1999. 3. Gallery EDM, Delprado W and Gyory AZ (1981). Antihypertensive effect of plasma volume expansion in pregnancy- associated hypertension. Aust NZ J Med 11, 20-24. 4. Kirshon B, Moise KJ, Cotton DB, Longmire S, Jones M, Tesem J and Joyce TA (1988). Role of volume expansion in severe pre-eclampsia. Surg Gynecol Obstet 167, 367-371. 5. Visser W and Wallenburg HCS (1995). Maternal and perinatal outcome of temporizing management in 254 consecutive patients with severe preeclampsia remote from term. Eu J Obstet Gynecol Repro Med 63, 147-154. 6. Eclampsia Trial Collaborative Group. Which anticonvulsant for women with eclampsia? Evidence from the Collaborative Eclampsia Trial. Lancet 1995, 345:1455-63. 7. The Magpie Trial Collaboration Group. Do women with pre eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1, 359(9321):1877 90. 8. Sibai B. A comparison between IM and IV magnesium sulphate regimes in pre eclampsia. American Journal of Obstetrics and Gynaecology 1994, 150:728733. 9. Roberts WE, Perry KG, Woods JB, Files JC, Blake PG, Martin JN. The intrapartum platelet count in patients with HELLP syndrome - is it predictive of later haemorrhagic complications? Am J Obstet Gynecol 1994; 171:799-804. 10. Hayman RG, Baker PN. The hypertensive disorders of pregnancy. Definitions, classifications and haematological investigations. PACE review 97/05. London: RCOG 1997

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3. Monitoring compliance and effectiveness

Element to be monitored The audit will take into account record keeping by obstetric, anaesthetic and paediatric doctors, midwives, nurse, students and maternity support workers. The results will be inputted onto an excel spreadsheet The audit will be registered with the Trusts audit department Maternity risk management midwife

Lead Tool

The following will be monitored for women with a diagnosis of sever pre eclampsia and eclampsia: Was a plan for blood pressure control written in the womans notes Was fluid balance monitored hourly Was an indwelling foleys catheter inserted If urine output <80 mls in 4 hours, was an obstetrician informed and a management plan documented in the womans notes If an eclamptic fit occurred was magnesium sulphate used. If severe pre eclampsia was magnesium sulphate considered. Was a CTG performed on admission to delivery suite and discontinued appropriately If conservation management planned, was an ultra sound assessment performed for fetal size, umbilical artery doplers and liquor volume Was blood pressure control achieved prior to delivery If there were fetal concerns, were the neonatal team informed prior to delivery. Frequency All the health records of women who have delivered with a diagnosis of eclampsia will be audited continuously, over a 12 month period 1% or 10 sets, whichever is the greater, of all health records of women who have delivered with a diagnosis of severe pre eclampsia will be audited over a 12 month period. Reporting A formal report of the results will be received annually at the arrangements maternity risk management and clinical audit forum, as per the audit plan During the process of the audit if compliance is below 75% or other deficiencies identified, this will be highlighted at the next maternity risk management and clinical audit forum and an action plan agreed. Acting on Any deficiencies identified on the annual report will be recommendations discussed at the maternity risk management and clinical audit and Lead(s) forum and an action plan developed Action leads will be identified and a time frame for the action to be completed by The action plan will be monitored by the maternity risk management and clinical audit forum until all actions complete
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Change in practice and lessons to be shared

Required changes to practice will be identified and actioned within a time frame agreed on the action plan A lead member of the forum will be identified to take each change forward where appropriate. The results of the audits will be distributed to all staff through the risk management newsletter/audit forum as per the action plan

4. Equality and Diversity

4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement.

4.2. Equality Impact Assessment

The Initial Equality Impact Assessment Screening Form is at Appendix 2.

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Appendix 1. Governance Information

Document Title Date Issued/Approved: Date Valid From: Date for Review: Directorate / Department responsible (author/owner): Contact details: Clinical guideline for the management of a woman with eclampsia and/or sever pre eclampsia 24th September 2012 24th September 2012 1st September 2015 Karen Watkins Obs and gynae directorate 01872 252719 This document gives guidance to obstetricians, anesthetists, midwives and delivery suite nurses on the recognition and management of eclampsia and sever pre eclampsia Eclampsia, sever pre eclampsia, PET, hypertension in pregnancy RCHT PCT CFT Medical Director August 2012 Severe Pre eclampsia/Eclampsia Guidelines Maternity guidelines group, labour ward forum, obs and gynae directorate meeting

Brief summary of contents

Suggested Keywords: Target Audience Executive Director responsible for Policy: Date revised: This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder

{Original Copy Signed} Internet & Intranet Intranet Only

Midwifery and obstetrics Anaesthetics

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Links to key external standards Related Documents: Training Need Identified? Version Control Table Date August 2007 Versio n No V1.0

CNST 3.1 & 3.2

Included in the in house annual update day

Summary of Changes Initial Issue

Changes Made by (Name and Job Title) Rob Holmes Consultant obstetrician Karen Watkins Consultant obstetrician Karen Watkins Consultant obstetrician Karen Watkins Consultant obstetrician

June 2009 V1.1

Updated guideline.

May 2012 V1.2 August 12 V1.3

Updated and compliance monitoring included Changes to compliance monitoring only

All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager.

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Appendix 2.Initial Equality Impact Assessment Screening Form

Name of service, strategy, policy or project (hereafter referred to as policy) to be assessed: Clinical guideline for the management of a woman with eclampsia and/or sever pre eclampsia Directorate and service area: Is this a new or existing Procedure? Obs and gynae directorate Existing Name of individual completing Telephone: assessment: Jan clarkson 01872 252270 1. Policy Aim* This document gives guidance to obstetricians, anesthetists, midwives and delivery suite nurses on the recognition and management of eclampsia and sever pre eclampsia 2. Policy Objectives* To ensure that pregnant women who are developing eclampsia/sever pre eclampsia are recognised and treated inline with national guidance Save outcome for women and babies

3. Policy intended Outcomes* 5. How will you measure the outcome? 5. Who is intended to benefit from the Policy? 6a. Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? b. If yes, have these groups been consulted? c. Please list any groups who have been consulted about this procedure.

Compliance monitoring tool

Women and babies

*Please see Glossary 7. The Impact Please complete the following table using ticks. You should refer to the EA guidance notes for areas of possible impact and also the Glossary if needed. Where you think that the policy could have a positive impact on any of the equality group(s) like promoting equality and equal opportunities or improving relations within equality groups, tick the Positive impact box. Page 14 of 15

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Where you think that the policy could have a negative impact on any of the equality group(s) i.e. it could disadvantage them, tick the Negative impact box. Where you think that the policy has no impact on any of the equality group(s) listed below i.e. it has no effect currently on equality groups, tick the No impact box. Positive Impact Negative Impact No Impact Yes Yes Yes Reasons for decision All women All women All women

Equality Group Age Disability Religion or belief Gender Transgender Pregnancy/ Maternity Race Sexual Orientation Marriage / Civil Partnership

Yes Yes Yes Yes Yes

All women All women All women All women All women

Yes

All women

You will need to continue to a full Equality Impact Assessment if the following have been highlighted: A negative impact and No consultation (this excludes any policies which have been identified as not requiring consultation). 8. If there is no evidence that the policy promotes equality, equal opportunities or improved relations - could it be adapted so that it does? How? Full statement of commitment to policy of equal opportunities is included in the policy

Please sign and date this form. Keep one copy and send a copy to Matron, Equality, Diversity and Human Rights, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Chyvean House, Penventinnie Lane, Truro, Cornwall, TR1 3LJ A summary of the results will be published on the Trusts web site.
Signed: Jan Clarkson

Date 28th August12

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