Second Trimester Miscarriage Management Clinical …...Second Trimester Miscarriage Management...

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Second Trimester Miscarriage Management Clinical Guideline V3.0 October 2019

Transcript of Second Trimester Miscarriage Management Clinical …...Second Trimester Miscarriage Management...

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Second Trimester Miscarriage Management Clinical Guideline

V3.0

October 2019

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Summary

Missed miscarriage / IUD < 24 weeks gestation

Spontaneous miscarriage / labour < 24 weeks

Sensitive discussion by consultant /appropriate SpR re: Individualised management plan

Available options including conservative management and induction of labour

Timing of induction of labour (IOL)

Place of birth (Bereavement Suite / Delivery Suite, Birth Centre or homebirth

Pain relief

Induction medication and analgesia prescribed

Diagnosis confirmed by USS 2

nd scan offered

Admission for IOL at time to suit parents

Woman to be assigned named midwife

Care in labour as RCHT guideline

Sensitive initial discussion on investigations including post mortem (> 16 weeks gestation only) Parent`s questions answered

Baby Born

Checklist of actions by Midwives / Bereavement

Midwives

Checklist of actions by Medical staff

Detailed 2nd

discussion on post mortem and tissue

sampling for genetic testing

Clinical care and emotional support for parents Assist parents to see / hold their baby and with memory making Issue Crematorium Committee Certificate of Medical Practitioner or Midwife in Respect of Fetal Remains Referral to outside agencies including MBRRACE-UK (> 22 weeks only) Conduct Perinatal Mortality Review using PMRT (> 22 weeks only)

Bereavement Care Co-ordinator

/Mortuary staff

Chaplaincy Bereavement Midwives

Community Midwife

Post mortem pathway initiated if consent given

Post mortem report + other investigation

results collated

Follow up care Perinatal Mortality Case Review (> 22

weeks only)

Follow up letter / appointment with named Consultant +/-Bereavement Midwife Feedback results Give parents written PMRT final report

Case review findings reported to Trust Board via Mortality Review Oversight

Group. Learning feedback to staff

Collective cremation arranged if it is the

parent`s choice

Consultant

Sensitive discussion before delivery on poor prognosis/ possibility of live

birth

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1. Aim/Purpose of this Guideline 1.1. The loss of a pregnancy at any gestation is traumatic for the parents, who deserve to be cared for with empathy and compassion. This guideline is intended to be used in conjunction with the Miscarriage National Bereavement Care Pathway and RCHT Miscarriage Checklist to provide best practice recommendations for staff providing care and support to women following a second trimester pregnancy loss (14 weeks - 23+6 weeks). The guideline is also relevant to situations where maternal well-being is compromised and delivery indicated before 24 weeks gestation. (New 2019) 1.2. This version supersedes any previous versions of this document. 1.3. Data Protection Act 2018 (General Data Protection Regulation – GDPR) Legislation The Trust has a duty under the DPA18 to ensure that there is a valid legal basis to process personal and sensitive data. The legal basis for processing must be identified and documented before the processing begins. In many cases we may need consent; this must be explicit, informed and documented. We can’t rely on Opt out, it must be Opt in. DPA18 is applicable to all staff; this includes those working as contractors and providers of services. For more information about your obligations under the DPA18 please see the ‘information use framework policy’, or contact the Information Governance Team [email protected]

2. The Guidance

2.1. Best practice in bereavement care

2.1.1 Parents should be listened to and given time, information and support to make informed decisions relating to their care. 2.1.2 Care should meet the personal cultural and religious needs of the parent’s babies.

2.1.3 Assumptions should not be made about how an individual will feel about their loss 2.1.4 A partner`s needs for support should be recognised and met 2.1.5 Communication with parents should be clear, sensitive and honest. Use the terminology used by the parents e.g. fetus or baby. (New 2019)

2.1.6 Good communication is required between all professionals to ensure that parents do not have to repeatedly explain their situation. Continuity and consistency of care are important

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2.1.7 Women and their partners should have their care coordinated by staff who are trained in bereavement care and in an environment appropriate to their circumstances. All staff that care for parents before, during or after stillbirth should have opportunities to develop and update their skills in bereavement care. (New 2019) 2.1.8 All bereaved parents should be offered opportunities to create memories. 2.1.9 The bodies of babies should be treated with respect at all times and at all gestations. 2.1.10 Staff should recognise the particular needs of other family members e.g. siblings and grandparents and support them including by signposting to support organisations.

2.2. Diagnosis and delivering news of intrauterine death (IUD)

2.2.1 In women who present with abdominal pain, vaginal bleeding or spontaneous miscarriage the diagnosis may be clinical. Women may present with a history of ruptured membranes or subtle signs such as increased vaginal discharge of feeling pressure in the vagina. In some circumstances the woman may be asymptomatic and the diagnosis made during a routine ultrasound scan. (New 2019) 2.2.2 When fetal demise is suspected and the woman is not actively miscarrying confirmation (New 2019) must be made by two-dimensional ultrasound at the earliest opportunity. If diagnosis is suspected the community the woman should be referred to the Day Assessment Unit (DAU) where an urgent scan must be performed in the Fetal Medicine Centre will be arranged. However if out of normal working hours a practitioner with appropriate training may use a portable ultrasound machine. If an obstetrician has any doubt about their abilities he or she should seek urgent assistance. 2.2.3 A second opinion should be sought whenever practically possible although it is recognised that this may not always be possible in emergency situations.

2.2.4 Parents should not be asked to wait in a waiting area with other pregnant women, but should be shown to a private room to await further care. 2.2.5 Following diagnosis and confirmation of fetal demise the parents must be given time to absorb and accept this news. A clear, sensitive and honest explanation should be given as to what has happened by experienced staff. The language used should be clear euphemisms or acronyms. For example:

“I`m really sorry, I can see your baby`s heart properly and it is not beating. I am sorry this means that your baby has died”

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2.2.6 If the woman is on her own, unless it is an emergency, it may be prudent to delay detailed explanation before support has arrived. An immediate offer to call her partner or other appropriate support person should be made. 2.2.7 If the woman had been feeling fetal movements before diagnosis, the possibility of passive movements should be discussed with her. If the woman reports passive movements after the scan to diagnose IUD, a repeat scan should be offered.

2.3 Initial management after diagnosis

2.3.1 Use the required paperwork and Miscarriage Checklist in blue “Miscarriage” ring binder found in the satellite mortuary/ nursery on Wheal Rose. Please file forms as they are completed in the medical notes and do not leave in the ring binder (Data Protection). 2.3.2 Take a history and perform basic maternal observations and antenatal examination (and any other relevant systems). Ensure that you have excluded serious underlying diagnoses such as pre-eclampsia, concealed abruption or chorionamnionitis. 2.3.3 Although it is important not to overload the parents with too much detail initially, it is important to give adequate information. It is good practice to have an early discussion about what to expect in terms of induction, analgesia, delivery, appearance of baby, memory boxes and investigations that will be offered. (New 2019) 2.3.4 Give parents the Sands Bereavement Support Pack, RCHT leaflet: Following the loss of your baby and Bereavement Midwives / ward contact number card. Discuss the content of leaflets with parents as they may be too overwhelmed to read the information they need. Parents may prefer to use the Sands App for their phone or tablet. 2.3.5 As soon as practically possible involve a Bereavement Midwife to provide ongoing support 2.3.6 Laboratory tests are recommended to assess maternal wellbeing and to determine the cause of death, the chance of recurrence and possible avoidance of further pregnancy complications. Certain tests are routinely recommended, others on a selective basis depending on the clinical picture. Note that certain tests are recommended before delivery. Senior advice must be sought when there is uncertainty as to the necessity of an individual test. Women should have venipuncture for maternal investigations following fetal demise. Test request forms may be printed using Maxims dataset - Stillbirth. 2.3.7 Keilhauer to identify fetomaternal haemorrhage should be taken as early as possible after presentation. 2.3.8 Women who are rhesus D (RhD) negative should have Anti-RhD

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gammaglobulin administered as soon as possible after presentation. This includes multiple pregnancies where one or more babies has died and the pregnancy is continuing. 2.3.9 Inform the GP, Community Midwife and Bereavement Midwives of the diagnosis and management plan. 2.3.10 Cancel all outstanding appointments.

2.4 Consultant Responsibility

2.4.1 If previously booked under Midwife led care the woman should be transferred to consultant led care 2.4.2 The Lead Obstetrician is the consultant with whom the woman has booked for the pregnancy or is responsible for the geographical area where the woman lives 2.4.3 For out of county cases, the Lead Professional is the Duty Consultant at the time the woman presents to the hospital (on call consultant unless there has been involvement by another consultant during a Delivery Suite session) 2.4.4 In selected cases, by agreement between Consultants, the entire episode including in-patient care and follow up may be overseen by the “admitting” consultant to maintain continuity of care

2.5 Induction of labour and delivery management Parents should be included in discussions about management. Options could include medical management / induction or expectant management. Many parents are surprised and shocked that they will still have to go through labour. Also that they may go home whilst awaiting delivery and that there may be a delay in giving birth to their baby. The Individualised risks and benefits of each option, including the time induction may take, should be discussed with the parents. (New 2019)

2.5.1 It is important that parents are able to make fully informed choices about their care. Being involved in the decision making process may help parents maintain a sense of control at a time when they feel they have little or no control, which may have longer-term implications for their mental health. 2.5.2 Questions should be welcomed and encouraged. 2.5.3 Induction of labour is recommended if there are signs of sepsis, pre-eclampsia, placental abruption or if membranes have ruptured as these carry potential risks to the woman`s health. 2.5.4 Significant bleeding should prompt resuscitation and involvement of a senior obstetrician.

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2.5.5 Parents who are in shock may find it difficult to process and retain information so provide written information and named contact details. 2.5.6 Consent should be taken prior to induction of labour and the use of misoprostol discussed. 2.5.7 Mifepristone is an anti-progesterone steroid used as a pre-treatment. It facilitates uterine response to subsequent administration of prostaglandin and takes time to work so is given before prostaglandin. This drug must only be administered in a maternity unit and patients should be observed when taking this medication. Contraindications include uncontrolled asthma, chronic renal, liver or adrenal failure and acute porphyria. 2.5.8 In the absence of an obstetric complication that necessitates close observation; oral Mifepristone 200mg should be given at a time to suit the parents, with a view to the woman going home and returning to the Bereavement Suite in 36-48 hours to continue induction of labour with Misoprostol. This will reduce the risk of a prolonged and potentially distressing in-patient stay. If the parents are adamant they do not wish to go home or the mother requires closer observation they should be cared for in the Bereavement Suite while awaiting the 2nd phase of induction of labour. 2.5.9 Women should be made aware that they may experience modest bleeding and abdominal cramps following Mifeprostone. Women should be advised to take simple analgesia, but to avoid those containing ibuprofen. Headaches, nausea and skin rashes may also occasionally.

Misoprostal should be prescribed using EPMA package < 24 weeks as per section 2.6

2.5.10 Complete the pre-admission sections of the Miscarriage Checklist before the parents leave the hospital. Individual items should be signed and dated by the doctor or midwife who provides that care. The checklist should be filed in the medical notes. 2.5.11 Unless the woman declines, the updated maternity notes should be returned to the woman to ensure that clinical information is available if required prior to admission to hospital.

2.6 Induction of Labour Medication Regimen:

2.6.1 Following Mifepristone the patient is admitted as above for the following Misoprostol regimen (New 2019) 2.6.2 Vaginal Misoprostol 200 micrograms should be given in the posterior fornix every three hours x 5 doses. (New 2019) 2.6.3 The risk of uterine rupture with misoprostal, although small, is increased in women with a second trimester loss with a uterine scar. Staff should be vigilant to clinical features that may suggest uterine scar dehiscence or rupture e.g. maternal tachycardia, atypical pain, vaginal

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bleeding, haematuria and maternal collapse (New 2019) 2.6.4 If labour is not established after 5 doses, the woman should be reviewed by a senior obstetrician – consider repeat Misoprostal at least 12 hours after the last dose. (New 2019) 2.6.5 Side effects include nausea, vomiting, pyrexia, tachysystole, itching and hypertension. 2.6.6 Once labour is fully established further vaginal misoprostol can be withheld.

2.7. Women with ruptured membranes There is no evidence in the literature as to an optimal regime for induction when the cervix is dilated and/or the membranes are ruptured. Although logically in such situations avoidance of multiple digital examinations may reduce the risk of ascending infection; there is a lack of evidence to guide practice. In such circumstances, and if the clinician wishes to avoid the use of vaginal misoprostol, intravenous oxytocin may be considered after discussion with a Consultant Obstetrician. However, the oxytocin regime has a longer mean time to delivery. (New 2019) 2.8. Expectant management

2.8.1. If the woman opts for expectant management or medical management at home, explain what she can expect regarding pain and bleeding during and after the miscarriage. Offer advice on over-the-counter options for analgesia (New 2019) 2.8.2 Women who delay medical management for more than 48 hours are advised to have testing for disseminated intravascular coagulation (DIC) twice weekly. (New 2019) 2.8.3 Parents should be advised that if expectant management chosen then the appearance of the baby may deteriorate and the value of some information may be reduced. 2.8.4 Women should be supported in their decision, but be aware that they may change their mind at any time. Arrangements should be made for further review.

2.9. Spontaneous Miscarriage 2.9.1. Delivery at the Threshold of Viability When it is apparent that a mother will deliver her baby at a very early gestation, the obstetric history and antenatal course must be considered carefully with particular attention to ultrasound scans to accurately calculate gestation. Whenever possible antenatal management decisions should involve both parents and clinical staff. (New 2019)

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2.9.1.1. 23+0 weeks to 23+6 weeks If gestational age is certain at 23+0–23+6 weeks and the fetal heart is heard during labour, a professional experienced in resuscitation should to attend the birth. A decision not to start resuscitation may be appropriate in the best interests of the baby, particularly if the parents have expressed this wish following antenatal counselling. However, if following counselling by the neonatal registrar/consultant, the parents wish their baby to be resuscitated (or where there is no time for discussion with the parents), the neonatal team should be present at delivery. The EPICure 2 study (2006) showed that at this gestational age, only 66/416 babies alive at the onset of labour survived to discharge (15%), whilst only 23% of survivors had no major morbidities12. 22+0 weeks to 22+6 weeks (New 2019) 2.9.1.2. <23 weeks If the gestational age is certain and less than 23+0 weeks it is considered in the best interests of the baby, and standard practice, for resuscitation not to be carried out. In the EPICure 2 study survival remained extremely rare at this gestational age (less than 1% at 22 weeks, as only 3 out 478 survived to discharge and of those, only 1 survived without major morbidity). The obstetric team should discuss this with the parents and document the discussion. The parents should be informed that their baby may attempt to gasp and move when born, will be kept comfortable, treated with respect, dignity and love. (New 2019) 2.9.1.3. Uncertain gestation If the gestation is uncertain, or where there is parental request for resuscitation, Parents should be given the opportunity to discuss management with the neonatal team. A plan of care should be agreed and documented including the implications of signs of life being seen and any decision to attempt resuscitation. This would not automatically mean that the baby is resuscitated; the final decision lies with the neonatologist present at delivery after careful assessment of the baby. Resuscitation may be appropriate if baby is born vigorous and of an apparently good birth weight. (New 2019)

2.10. Signs of Life Delivery at gestations from 16 weeks onwards may result in the baby being born with signs of life including spontaneous breathing, heartbeat, and pulsation of the umbilical cord or definite movement of voluntary muscles. Please refer to the National Bereavement Pathway for Neonatal Death (2018) and RCHT Guideline for Management of Early Neonatal Death (New 2019) 2.11. Labour and birth

2.11.1 In some cases late miscarriage starts in a way that is similar to going into labour. This may be a very distressing and frightening experience, especially once it is clear that the baby is not going to survive. Staff should offer particularly sensitive support and information throughout the process, including options for pain relief and place of care. (New 2019)

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2.11.2 Care in labour should be the same as normal care in labour a partogram should be used from 22 weeks (New 2019) 2.11.3 If there is a fetal heartbeat the woman/couple should be told about any care that might be given to the baby if s/he is born alive. Staff should recognise that many women/couples will see this process as a premature labour and stillbirth rather than a miscarriage (New 2019) 2.11.4 Women should be able to have her partner and / or another supporter with her at all times. 2.11.5 The partner / supporter should be kept fully informed and involved (with woman`s consent). A partner’s grief can be as profound as that of the mother; their needs for support should be recognised and met. 2.11.6 In the absence of co-existing complications, labour and birth will ideally take place in the Bereavement Suite on Wheal Rose antenatal ward. (New 2019) 2.11.7 Women with sepsis should be treated with intravenous broad spectrum antibiotics after a sepsis screen has been performed. (New 2019) 2.11.8 Women with second trimester loss and GBS colonization of the vagina do not require antibiotic prophylaxis in labour (New 2019) 2.11.9 Regular reassessment for appropriate place of care and appropriate seniority of staff should be made throughout patient admission and documented in the notes 2.11.10 Ensure that all staff seeing parents during labour and birth are aware of the pregnancy loss/ baby`s death and communicate sensitively. 2.11.11 Display laminated “Daisy” sign on door. To ensure all staff are aware that the room is being used by bereaved parents and are sensitive to noise and prevent inappropriate comments by well-meaning staff. 2.11.12 The swift board should be noted with a Sands logo symbol to help notify staff and aid communication. 2.11.13 Ensure continuity of carer whenever possible. 2.11.14 Inform the Delivery Suite Co-ordinator and on call middle grade obstetrician of the admission and request that the case is recorded on the D/S board. Avoid routine rupture of membranes in labour to reduce infection risk. 2.11.15 If after spontaneous labour at any gestation, the baby shows obvious signs of life, the Early Neonatal Death Guideline should be followed.

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2.11.16 3rd stage should be actively managed. In the case of retained placenta they should be managed as per RCHT Clinical Guideline for Diagnosis and Management of Retained Placenta (2017). 2.11.17 Women should be informed that there is a higher incidence of retained products of conception compared to first trimester miscarriage. A low threshold for evacuation of retained products should be adopted. (New 2019) 2.11.18 If there is any concern that the placenta is not complete on examination arrange a follow up appointment for the Emergency Gynae Unit (EGU). This may be an out- patient appointment. (New 2019)

2.12. Pain management

2.12.1 A range of analgesia and anti-emetics should be prescribed. All women should be given appropriate information regarding pain relief options including advantages and disadvantages. 2.12.2 Options include, water therapy, TENS machine, Patient controlled analgesia (PCA), oral analgesia, diamorphine/pethidine.

2.13. Miscarriage in a community setting

2.13.1 Some women experiencing late miscarriage may prefer to give birth at home. Ideally, parents should be given options for their place of care regardless of gestation. (New 2019) 2.13.2 For some women, labour may progress quickly and they may give birth at home or in another place. Women should be offered a physical assessment for themselves and their baby even if no healthcare professionals were present when the baby was born. (New 2019) 2.13.3 The baby may remain at home / await collection by the Funeral Director engaged by the parents. A cold cot may be obtained from Wheal Rose ward and loaned to the parents if they wish to keep their baby at home. 2.13.4 If post-mortem or cytogenetic tests are requested or the mother is admitted to the maternity unit the baby should be transported to RCH with the mother. Skin biopsy for cytogentic testing (See Appendix 4) must be taken in Wheal Rose satellite mortuary / nursery. 2.13.5 If not present at the birth, the community midwife should examine the baby / fetal remains to enable them to confirm that the miscarriage took place prior to 24 weeks gestation on the Certificate of Medical Practitioner or Midwife in Respect of Fetal Remains form. If there are questions around the gestation, the midwife should consult with a bereavement midwife or consultant. (New 2019)

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2.14. Investigations on the baby and placenta

2.14.1 Parents choose to have investigation to find out why their baby died, to allow their grief to progress, to find out information useful to subsequent pregnancies and for research to prevent stillbirths in the future. However, depending on how extensively the woman wishes to be investigated, the cause of second trimester loss may remain unexplained in up to half of cases (New 2019) 2.14.2 Postmortem examination and placental histology should be offered to all women who experience a second trimester miscarriage > 16 weeks. However parents and clinicians should understand that the information gained at early gestations might not be as helpful as in later gestations. (New 2019) 2.14.3 Where there is fetal malformation and the cause is known investigation should be advised by the Consultant managing the case 2.14.4 It is good practice to have a detailed discussion on at least two separate occasions with the family. 2.14.5 It should be explained to the parents that different types of postmortem are available e.g. full, limited or external. 2.14.6 Parents should be made aware that specialist perinatal postmortem examination takes place in Bristol 2.14.7 Consent should be sought by a member of staff who has received training in seeking post mortem examination consent and the process and who has a good understanding of the procedures for which they are seeking consent (Appendix 3 Sands Guide for consent takers) - . It is a process that should involve careful listening and discussion 2.14.8 Cytogenetic tests should be offered, with written information, in all cases especially if post mortem has been declined. This ideally should be taken from placenta and skin, but placental biopsy alone may help. 2.14.9 To comply with Human Tissue Act regulations skin biopsy should be taken in the Bereavement Nursery in accordance with guidance: Cytogenetics Samples after Pregnancy Loss (Appendix 4) 2.14.10 If postmortem is declined an experienced clinician should examine the baby and document findings. 2.14.11 If there are any signs of abnormality and post mortem has been declined x-ray of the baby should be considered. 2.14.12 Swabs from the baby and placenta should be taken if infection is suspected. 2.14.13 A cotyledon should be sent to microbiology for culture prior to being

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placed in formalin. 2.14.14 The remaining placenta should be placed in formalin and sent to the mortuary with the baby to be sent to Bristol for histopathological investigations. The specimen should be accompanied by the postmortem request even if the baby is not undergoing postmortem.

2.15. Caring for the baby and making memories

2.15.1. Labelling a baby

2.15.1.1. At delivery label the baby with a nameband in accordance with the RCHT Clinical Guideline for Newborn Identification and Labelling (2017). At earlier gestations place the Name band around the baby`s abdomen. (New 2019) 2.15.1.2 Once the baby is ready to go to the mortuary replace this name band with a mortuary identification label which should have 3 points of reference: - “baby of” (mother`s full name), date and time of birth, and in indelible ink. Offer the original name band to parents. 2.15.1.3 Put “red sticker” identifier on deceased baby care record, stillbirth checklist, and postmortem consent form if appropriate.

2.16. Cuddle cot cold mattress

Caring for the baby on a cold mattress allows the family to spend more time with their baby. The appropriate sized cold mattress should be set up to operate at a temperature between 8-13 degrees Celsius. Cold mattress guidance and temperature record are included in the Miscarriage Checklist. 2.17. Seeing and holding the baby

2.17.1 Depending on the condition of the baby / fetal remains discuss with parents seeing and / or holding their baby / fetal remains while respecting that some parents may decline this offer. It is essential to offer genuine choice and not to steer parents towards a particular course of action in the belief that it will help them (New 2019) 2.17.2 The parents should be aware that they can change their mind at any time. 2.17.3 The condition of the baby should be considered when discussing memory making with parents. Parents should be sensitively informed of how their baby may look when born considering gestation, known abnormality, macerated or severely hydropic babies.

2.18. Creating Memories

2.18.1. All staff should use the baby’s name if one has been given.

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2.18.2 Do not make assumptions about what parents may want based on the gestation of their pregnancy (New 2019) 2.18.3 It can be difficult for staff to know whether or not to offer to take photographs of a miscarried baby or pregnancy remains. Some women/couples will appreciate the offer of a photograph being taken of their baby or the pregnancy remains even in a very early loss, while others might find the suggestion distressing, unacceptable or not needed even with a later loss. (New 2019) 2.18.4 If parents are undecided regarding photos they can be taken but kept in a sealed envelope in the mother`s notes if the parents wish. 2.18.5 The camera log book should be completed to comply with Information Governance regulations. Parents should be given the memory card or file it in the medical notes. No images must remain on the camera. 2.18.6 Offer a memory box (A Sands or a smaller 4Louis miscarriage memory box) with:

Scan photos

Hand and foot prints

Cot card

Certificate of Acknowledgement of Loss

Teddy bear

Blanket

Not all of the above list will be possible or appropriate in early gestations. (New 2019) The memory box does not need to be filled as it is designed for the parents to add their own memories. 2.18.7 Offer parents a leaf engraved with their baby`s name to be added to the Memory Tree situated in the Baby Memorial Garden and the option of having their baby`s name entered in the hospital Book of Remembrance in the Chapel. Complete and forward the relevant request forms as directed.

2.19 Pastoral Care

2.19.1 Staff should be aware of, and open to, different personal, religious and cultural needs. Assumptions should not be made, however, about what any individual will want on the basis of their heritage or religion. 2.19.2 Discuss with parents whether they wish to speak with the hospital Chaplain 2.19.3 Parents should be informed that the Chaplaincy Team will be able to put them in touch with a representative of their faith, wherever possible. 2.19.4 Offer a Blessing/Naming ceremony. The on call Hospital Chaplain may be contacted day or night via Switchboard.

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2.19.5 Inform parents of the RCHT annual Service of Remembrance in October and give information / consent for invitation form.

2.20 Legal Requirements.

2.20.1 There is no legal requirement for registration of babies born deceased before 24 weeks gestation. An alternative Acknowledgement of Loss Certificate should be completed and offered to parents in lieu of a Stillbirth Certificate (New 2019) 2.20.2 The Crematorium Committee Certificate of Medical Practitioner or Midwife in Respect of Fetal Remains form should be completed by a doctor or registered midwife who has examined the baby. This form should accompany the baby to the mortuary or funeral director. (New 2019)

2.21 Reporting and Investigation (> 22 weeks gestation only)

2.21.1 The Bereavement Team will submit patient details to the MBRRACE-UK portal. Parents should be informed that their details are being submitted to the national database (Data Protection Act 2018). 2.21.2 A detailed case review using the web-based Perinatal Mortality Review Tool (PMRT)/ pathway and involving the parents will be conducted. Parents should be informed that their details are being submitted to the national database (Data Protection Act 2018). 2.21.3 Parents should be invited to contribute to the case review and their perspective of events sought. 2.21.4 The perinatal mortality review findings will be discussed with the parents at their follow up appointment with the named consultant. Parents will also receive a written PMRT report. 2.21.5 A summary of the case review will be submitted to the Trust Board via the RCHT Mortality Review Oversight Group in the quarterly report.

2.22 Taking the baby out/home

2.22.1 There are no legal reasons to prevent parents from taking their baby home. Parents should be offered the opportunity to take their baby home or out of the hospital. This discussion should be recorded in the Miscarriage Checklist. 2.22.2 There is no legal reason to inform the police if parents take their baby’s body home or out of the hospital. However, for the protection of the parents and to prevent misunderstandings, a Form for parents who take their baby`s body home (Appendix 5) should be given to the parents confirming that the body has been released to the parents and that they will be taking it back to the hospital or making their own funeral arrangements.

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2.22.3 Parents can take the baby home by car in a Moses basket secured by a seatbelt, in the parents’ arms or in a hospital casket. 2.22.4 A Cuddle cot cold mattress should be offered on loan to the parents.

2.23 Sensitive Disposal / Funerals

2.23.1 Provide information for parents about what happens to the baby/ fetal remains and complete the Sensitive disposal option form “ What happens to our baby”. (New 2019) 2.23.2 There is no legal requirement for a funeral for babies / fetal remains below 24 weeks gestation, (New 2019) but parents who experience a miscarriage or termination for any reason before 24 weeks’ gestation should be given the opportunity to discuss and make choices about their available options for the disposal of fetal remains 2.23.3 Individual cremation is still possible for fetal remains and babies born dead before 24 weeks’ gestation in Cornwall, if funded by the family. Parents should be aware that while there is no guarantee that ashes will be recovered from early gestation (<17 weeks) cremation, every effort is made for parents to receive ashes. (New 2019) 2.23.4 Parents may decide to organise the funeral themselves or use the services of a funeral director. If they wish to bury their baby in their own garden or in some other place that holds special meaning for them parents should be advised that they must have permission from the owner of the freehold of the land and ensure there are no deed restrictions preventing burial. They should also to seek advice from the local Environment Agency as the burial must meet Environment Agency regulations regarding the depth of burial, preparation of the grave and the distance of burial from specific water and drainage sources. The owner of the land or their agent must also keep a register of the details of the burial. (New 2019) 2.23.5 RCHT offers collective cremation for fetal remains / babies <24 weeks gestation cremation for fetal remains / babies < 24 weeks gestation. Parents should be informed that this service takes place on a monthly basis at Penmount Crematorium. Parents are not able to attend the service and individual ashes will not be available. (New 2019) 2.23.6 Staff should be aware that some cultures and religions do not traditionally hold funerals or other ceremonies for babies born before 24 weeks’ gestation. It should not be assumed however that this will be the case, and all parents should be offered information. (New 2019) 2.23.7 Some women may decline information about these options or involvement in decision-making processes regarding the disposal of fetal remains and this should be respected. If they have not made a decision prior to transfer home ensure that parents are aware that collective cremation will be arranged if the parents do not contact RCHT Bereavement Services (Tel: 01872 252713) after six weeks. The parents will not be informed of the cremation

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details. (New 2019)

2.24 Multiple Pregnancies

2.24.1 Clinicians should appreciate the complexity and mixed emotions of couples who experience stillbirth of one baby with a surviving twin. They will require the same support through delivery and bereavement care as other bereaved parents. Some parents may be distressed about the idea of the dead baby remaining with any surviving baby and others may find this thought comforting. Reassure parents that whatever they are feeling is normal. (New 2019) 2.24.2 The timing and mode of delivery for multiple pregnancies in the case of single fetal demise will depend on chronicity, gestation, the position of the fetuses and wellbeing of the surviving baby/babies. (New 2019) 2.24.3 Waiting to give birth may be difficult for parents who feel fearful for their surviving baby or babies and parents may feel reassured by additional antenatal contact. (New 2019) 2.24.4 If there is one or more surviving sibling from a multiple pregnancy, don`t focus solely on the surviving baby. Acknowledge the baby that has died and recognise the challenge the parents face in celebrating the birth of one baby and the death of the other baby/babies. 2.24.5 Discuss with the parents the options around future memory making with siblings. 2.24.6 The Butterfly Project supports parents who have lost a baby from a multiple pregnancy. When the loss happens before birth a small butterfly symbol can be placed on the woman`s handheld notes to alert clinicians of fetal demise in a multiple pregnancy. 2.24.7 With the parent`s consent a purple butterfly (TAMBA Butterfly Project) can be placed on the surviving sibling`s cot to alert staff that the baby was part of a multiple birth. 2.24.8 Signpost the parent`s to TAMBA for specialist bereavement support www.tamba.org.uk/bereavement

2.25 Postnatal Care of the Mother

Psychological Support All parents should be offered bereavement support.

Involve the Bereavement Midwives as soon as practically possible to provide ongoing support

Ensure that the parents have information on local and national support groups including contact details

With consent ensure handover of care to GP for the partner as well as

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the woman.

If the woman has ongoing psychological concerns the GP should be made aware

2.26 Lactation suppression Suppression of lactation should be discussed. Offer Cabergoline 1mg as a single dose from 18 weeks gestation unless contra-indicated or there is maternal hypertension or puerperal psychosis (New 2019) 2.27 Discharge from hospital

2.27.1 Perform a full postnatal examination including maternal observations, VTE assessment, and contraceptive advice before discharge 2.27.2 Ensure that the Miscarriage Checklist is complete before the parents go home. 2.27.3 Ensure that the woman has the RCHT leaflet Following the loss of your baby for information about what to expect in the postnatal period and knows how to contact her community midwife / Bereavement Midwives. 2.27.4 Signpost the parents to local and national support group and give contact numbers/ websites addresses 2.27.5. Ensure that parents are aware that they may return to see their baby if they wish. Parents should be advised to contact RCHT Bereavement Services office during office hours to make arrangement. Telephone : 01872 252713 2.27.6 With the mother`s consent inform the GP and community midwife of her discharge home and send a Transfer Summary to the GP. 2.27.7 The community midwife should contact the woman within 24 hours and offer a postnatal visit. The woman should not be asked to attend a clinical area for a postnatal check. 2.27.8 Seek consent for the parent`s participation in the Maternity Bereavement Experience Measure (MBEM) feedback in approximately six months. Document if this is declined.

2.28 Transport of the baby and placenta

2.28.1 When the parents have been discharged / said their final goodbyes, the baby is transferred to the mortuary in a casket lined with a plastic backed absorbent sheet by a porter. Record the porter`s name on the Deceased Baby Care Record. 2.28.2 The placenta, in Formalin, is also sent to the mortuary in a red transport box lined with an absorbent pad in accordance with COSHH requirements.

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2.28.3 The Certificate of Medical Practitioner or Midwife in Respect of Fetal Remains (cremation form), Sensitive Disposal “What happens to our baby” form, Deceased Baby Record and postmortem request and consent forms (if applicable) go with the baby to the mortuary.

2.29 Aftercare

2.29.1 Bereavement midwives to provide on-going bereavement support as required 2.29.2 Bereavement Midwives to collate investigation results and complete the PMRT report 2.29.3 Consultant debrief / investigation feedback to be arranged once all investigation results and PMRT final report (if applicable) are available. 2.29.4 If parents give consent to participate in giving feedback, Bereavement Midwives to send the Maternity Bereavement Experience Measure (MBEM) by post or e-mail in approximately six months (www.bit.ly/2DQ3Mjz)

3. Monitoring compliance and effectiveness

Element to be monitored

Proportion of parents receiving Sands Bereavement Support pack / local information leaflets

Proportion of women receiving 1:1 care in labour

Proportion of parents offered post-mortem examination

Proportion of women offered suppression of lactation

Proportion of women offered a follow up meeting with a senior obstetrician

Lead Bereavement Team

Tool Miscarriage Checklist

Frequency 25% cases to be monitored Quarterly Quarterly

Reporting arrangements

Perinatal Mortality Meeting / Maternity Forum Documented in meeting minutes

Acting on recommendations and Lead(s)

The named Bereavement Team will undertake subsequent recommendations and action planning for any or all deficiencies and recommendations within reasonable timeframes

Change in practice and lessons to be shared

Lessons learned will be shared with the relevant stakeholders via the Bereavement Newsletter and at the Perinatal Audit Meetings

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4. Equality and Diversity

4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Inclusion & Human Rights Policy' or the Equality and Diversity website.

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 Second Trimester Miscarriage Management Clinical Guideline V3.0

Date Issued/Approved: May 2019

Date Valid From: October 2019

Date Valid To: October 2022

Directorate / Department responsible (author/owner):

Karen Stoyles Bereavement Midwife

Contact details: 01872 252879

Brief summary of contents

To provide midwives, obstetricians and support workers with guidance in the provision of emotional support and clinical care following stillbirth

Suggested Keywords: Stillbirth, pregnancy, bereavement, post mortem

Target Audience RCHT CFT KCCG

Executive Director responsible for Policy:

Medical Director

Date revised: May 2019

This document replaces (exact title of previous version):

Pregnancy Loss and Early Neonatal Death – Clinical Guideline V2.0

Approval route (names of committees)/consultation:

Maternity Guidelines Group Obs and Gynae Directorate Meeting

Care Group Manager confirming approval processes

Debra Shields, Care Group Manager.

Name and Post Title of additional signatories

Not Required

Name and Signature of Care Group/Directorate Governance Lead confirming approval by specialty and divisional management meetings

{Original Copy Signed}

Name: Caroline Amukusana

Signature of Executive Director giving approval

{Original Copy Signed}

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Publication Location (refer to Policy on Policies – Approvals and Ratification):

Internet & Intranet Intranet Only

Document Library Folder/Sub Folder Midwifery and Obstetrics

Links to key external standards

References 1. Greentop Guideline No.55:Late

intrauterine Death and Stillbirth (2010) Royal College of Obstetricians and Gynaecologists, London. www.rcog.org.uk

2. Miscarriage: Bereavement Care Pathway. (2018) National Bereavement Care Pathway. www.nbcpathway.org.uk

3. Guide for consent takers. Seeking consent/authorisation for the post mortem of a baby. (2013) Sands, London www.sands.org.uk

4. Hunter A., Schott J., Henley A., Kohner N., (2016) Pregnancy loss and the death of a baby: Guidelines for Professionals. Sands www.sands.org.uk

5. Code A: Guiding principles and the fundamental principle of consent (2017) Human Tissue Authourity.

www.hta.gov.uk 6. When a Patient Dies: Advice on

Developing Bereavement Services in the NHS (2005) Department of Health www.dh.gov.uk

7. Learning from Deaths: Guidance for NHS Trusts on working with bereaved families (2018) www.dh.gov.uk

8. North West Coast Stategic Clinical Networks. (2018) Management of Second Trimester Loss Guideline. www.gmecscn.nhs.uk/images/menu/Maternity_Children_and_Young_People/NW_STPL_Guideline_V2_March_2018.pdf Link from Saving Babies Lives 2 (2019) www.england.nhs.uk/wp-content/uploads/2019/03/saving-babies-lives-care-bundle-version-two-final-version-4.pdf

Related Documents: None required

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Training Need Identified? Bereavement care training and annual updates for staff

Version Control Table

Date Version

No Summary of Changes

Changes Made by (Name and Job Title)

2008 1.0 Initial document

Karen Stoyles, Bereavement Midwife and Rob Holmes , Obstetric Bereavement Lead Consultant

January 2012

1.1 Updated guideline and compliance monitoring added

Karen Stoyles Bereavement Midwife

September 2012

1.2 Changes to compliance monitoring only Karen Stoyles Bereavement Midwife

October 2013

1.3 Amalgamation into generic Bereavement Guideline

Karen Stoyles Bereavement Midwife

December 2016

2.0

Section 2.13 updated: Placenta: Place in Formalin once microbiology and cytogenetic samples have been taken. Placenta to be transported in the red Pathology container and sent to the mortuary

Karen Stoyles Bereavement Midwife

March 2019 3.0

Separation into separate guidelines for each category of pregnancy loss / neonatal death to mirror National Bereavement Care Pathways and provide clarity.

Karen Stoyles Bereavement Midwife

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 for the Development and Management of Knowledge, Procedural and Web

Documents (The Policy on Policies). 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 Form

Name of Name of the strategy / policy /proposal / service function to be assessed Second Trimester Miscarriage Management Clinical Guideline V3.0

Directorate and service area: Obs & Gynae Directorate

Is this a new or existing Policy? Existing

Name of individual completing assessment: Karen Stoyles, Bereavement Midwife

Telephone: 01872 252879

1. Policy Aim*

Who is the strategy / policy / proposal /

service function aimed at?

To provide midwives , obstetricians and support workers with guidance in the provision of emotional support and clinical care following second trimester miscarriage

2. Policy Objectives*

To ensure parents receive appropriate care and support following second trimester miscarriage

3. Policy – intended Outcomes*

Consistent high quality care and support following intrauterine death and stillbirth

4. *How will you measure the

outcome?

Proportion of parents receiving Sands Bereavement Support pack / local information leaflets

Proportion of women receiving 1:1 care in labour

Proportion of parents offered post-mortem examination (> 16 weeks only)

Proportion of women offered suppression of lactation

Proportion of women offered a follow up meeting with a senior obstetrician

5. Who is intended to benefit from the

policy?

Bereaved parents following late fetal loss

6a Who did you consult with b). Please identify the groups who have been consulted about this procedure.

Workforce Patients Local groups

External organisations

Other

x x

Maternity Guidelines Group Obstetrics and Gynaecology Care Group Policy Review Group

What was the outcome of the consultation?

Guideline Agreed

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Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Unsure Rationale for Assessment / Existing Evidence

Age x All pregnant women

Sex (male,

female, trans-gender / gender reassignment)

x All pregnant women

Race / Ethnic communities /groups

x All pregnant women

Disability - Learning disability, physical impairment, sensory impairment, mental health conditions and some long term health conditions.

x All pregnant women

Religion / other beliefs

x All pregnant women

Marriage and Civil partnership

x All pregnant women

Pregnancy and maternity

x All pregnant women

Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian

x All pregnant women

You will need to continue to a full Equality Impact Assessment if the following have been highlighted:

You have ticked “Yes” in any column above and

No consultation or evidence of there being consultation- this excludes any policies which have

been identified as not requiring consultation. or

Major this relates to service redesign or development

8. Please indicate if a full equality analysis is recommended. Yes No

x

9. If you are not recommending a Full Impact assessment please explain why.

Not required.

7. The Impact Please complete the following table. If you are unsure/don’t know if there is a negative impact you need to repeat the consultation step.

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Date of completion and submission

2nd May 2019 Members approving screening assessment

Policy Review Group (PRG) APPROVED

This EIA will not be uploaded to the Trust website without the approval of the Policy Review Group. A summary of the results will be published on the Trust’s web site.

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Appendix 3 Sands Guide for Consent takers.

https://www.hta.gov.uk/policies/sands-perinatal-post-mortem-consent-package

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Appendix 4

Cytogenetic Samples after Pregnancy Loss

Introduction A vital part of investigation after late pregnancy loss is cytogenetic testing. It may also be offered after recurrent miscarriage, termination of pregnancy for fetal abnormality or early neonatal death. It is essential that tissue samples are obtained in a standardised manner to maximise the chance of accurate, comprehensive results and with due respect to the deceased. Appropriate documentation, training and audit is essential for a high quality service and is monitored by The Human Tissue Authority. Location for sample acquisition Tissue samples are taken in the Wheal Rose Ward Bereavement room, irrespective of place of delivery. As a licenced satellite mortuary this is the only appropriate setting for dignified and efficient sample collection. The only exception is recurrent first trimester miscarriage investigation which takes place, by necessity, in an operating theatre environment (see below). Consent for Cytogenetic testing Written consent is mandatory using the designated consent form (to be found in all Maternity Bereavement Packs, on the Emergency Gynaecology Unit, the gynaecology ward and in the Consent section of the Gynaecology intranet shared drive). It is used even if written consent for post-mortem has been obtained. If consent is obtained for skin biopsy, this should include consent for placental biopsy because the laboratory prefers to receive both samples. Consent is sought for placental biopsy alone if parents want the genetic information but are unhappy to give consent for skin biopsy (due to its invasive nature). Cytogenetic Sample Pots

Universal containers containing specific transport medium (‘For skin biopsy’) are stored at -20oC

in the fridge freezer in the Treatment Room on Wheal Rose ward

Do not use the CVS medium for any post-delivery samples

The medium is thawed before the sample is placed in the pot

Skin and placental samples are placed in separate pots

Pots are stored in the Bereavement Room fridge (not freezer) until transfer to Bristol Technique for sample collection

All equipment is kept in a labelled box in the Bereavement room

Sampling is a gloved non sterile technique with care to minimise contamination

Samples are obtained using an 6mm single use punch biopsy

Soft tissue of the thigh is held between thumb and fore finger and the punch biopsy gently pushed with a screwing action into the skin and underlying muscle to the full depth of the metal sampling cylinder

The tissue core is elevated using tissue forceps and its base attachment cut using a disposable blade.

The sample is placed into thawed ‘skin biopsy’ transport medium, ensure the lid is secured and label accurately

The same technique is used to obtain a placental biopsy, targeting the placenta close to the cord insertion and placed in a separate pot

Sample handling after collection

A cytogenetics request form is accurately completed with full details of clinical picture (include known anomalies, growth restriction, family history etc.) and referrer

Samples are placed in the Bereavement Room fridge, not the freezer compartment

Samples are boxed up by the Wheal Rose ward clerk and sent before 14.00 week days to the RCH post room for transfer to the Bristol Genetics Laboratory

Documentation

The clinician documents discussion of consent, obtaining consent and taking the samples on the ‘Checklist for Doctors’ found in all the Bereavement packs (Termination for fetal abnormality, Miscarriage before 24 weeks gestation, Stillbirth and Early Neonatal Death)

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The clinician taking the samples records the woman’s name, CR number, date and time of sample collection and their name, designation and signature in the Cytogenetics Ledger in the Bereavement room

The Wheal Rose ward clerk records in the Cytogenetics Ledger when the samples are transferred to the post room

Recurrent First Trimester Miscarriage

Documentation of the discussion and obtaining of consent is made in the hospital notes and the designated consent form is used

‘Skin biopsy’ medium (not ‘CVS’ medium) is obtained from the Wheal Rose freezer and thawed before use

Cytogenetic consent forms are available in the Bereavement room and in EGU

The sample is obtained in theatre during the ERPC operation and placed in the transport medium (without any attempt to distinguish fetal and placental tissues)

The sample is placed in the Bereavement room fridge with request form

Full documentation is entered into the Bereavement room Cytogenetics Ledger

The Wheal Rose ward clerk records in the Cytogenetics Ledger when the sample is transferred to the post room

Training Issues

Only individuals who have received documented training in Cytogenetic sample consent and collection may undertake the work

This guideline is placed in the Department Handbook given to all junior medical staff

Discussion of this guidance and a hardcopy are given to all medical staff at Induction

Signed confirmation that the doctor has read and understood the guidance and has been given the opportunity to receive satisfactory answers to any questions they have is obtained and held by the Department Medical Staffing Officer

No doctor performs this work if they are uncertain about their competence

Further training will be made available by the Bereavement Coordinators (Karen Stoyles and Rob Holmes) at request

Rob Holmes, Consultant Obstetrician and Karen Stoyles, Senior Midwife Bereavement Coordinators, February 2011 Reviewed February 2018

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Appendix 5 Form for parents taking a baby home

Form for parents who take their baby`s body home

TO WHOM IT MAY CONCERN

This is to confirm that (name(s) of parent(s) _______________________________________________________________________________ Of (address): ____________________________________________________________________

_______________________________________________________________________________

Have taken their baby`s body from Royal Cornwall Hospital Date:_____________

I/We, the parent(s), hereby take full responsibility for our baby whilst they are in our care. We will (tick as appropriate): Return our baby to the hospital on (date) ________________________ Make our own funeral arrangements

Parents(s) Names(s) (please print): _________________________________ ________________________________ Signature _________________________ Signature_________________________

Signature : ________________________ Name (please print) ______________________ In case of need or concern please contact: Staff member`s name __________________ Job Title _______________________________

Direct line: __________________________

24-hour phone contact: Wheal Rose Ward – 01872 252149