WAHT-GYN-001 It is the responsibility of every individual to check that this is the latest version/copy of this document.

MEDICAL MANAGEMENT OF MID-TRIMESTER (14+0 – 20+0 WEEKS) FETAL INTRAUTERINE DEATH OR TERMINATION OF USING /

This guidance does not override the individual responsibility of health professionals to make appropriate decision according to the circumstances of the individual patient in consultation with the patient and/or carer. Health care professionals must be prepared to justify any deviation from this guidance.

INTRODUCTION This guideline has been written to guide the medical management of mid-trimester (13- 20 completed weeks gestation) fetal intrauterine death or medical termination of pregnancy. The use of mifepristone and misoprostol for these clinical indications is thought to be less traumatic for the woman as well as being cost effective and evidence based.

THIS GUIDELINE TO BE USED BY: All medical staff and appropriately trained midwifery/nursing staff who are competent in administering vaginal prostaglandins

Lead Clinicians Miss A Blackwell Consultant Obstetrician-Gynaecologist Miss R Duckett Consultant Obstetrician-Gynaecologist Mr J Uhiara Consultant Obstetrician-Gynaecologist

Approved by accountable director: 27th March 2015

Extension approved by Trust Management Committee on: 22nd July 2015

This guideline should not be used after: 31st July 2016

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Key amendments to this guideline

Date Amendment By: 12th July Approved by Clinical Effectiveness Committee 2005

24th August Medicines Safety Committee 2005

19.07.07 Reviewed and agreed to continue for a further period without Miss A Blackwell amendment 27.11.07 Revised by Gynae Guidelines Group/ Pharmacist Miss A Blackwell 01.10.09 Review date extended without amendment Miss A Blackwell 24.12.09 Reviewed and extended for a further period without Miss A Blackwell amendment: 14.03.12 Changes to: Miss A Blackwell/  Location of admission and grade of obstetrician to be Miss R Duckett involved depending on gestation.  Clarification of arrangements for theatre.  procedure description to be used on Consent form “ - “Termination of Pregnancy and induction of labour with mifepristone and prostaglandins. +/- Evacuation of retained products of conception.” - For intrauterine deaths, consent form to state “Induction labour by prostaglandins +/- Evacuation of retained products of conception.” Agreed Gynaecology CG meeting. 16.05.12 Further clarification of referrals, arrangements for a bed, and Rachel Duckett forms to be used. Judi Barratt 14th June Reviewed and approved by Countywide Gynaecology Clinical 2012 Governance Committee 16/01/15 Document extended for 3 months while being transferred to Paul Moran pathway 27/03/2015 Document extended for 3 months while being transferred to Paul Moran pathway 10/08/2015 Document extended for 12 months as per TMC paper TMC approved on 22nd July 2015

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MEDICAL MANAGEMENT OF MID-TRIMESTER (14+0 – 20+0 WEEKS) FETAL INTRAUTERINE DEATH OR TERMINATION OF PREGNANCY USING MIFEPRISTONE/MISOPROSTOL

INTRODUCTION This guideline has been written to guide the medical management of mid-trimester 14+0 – 20+0 weeks gestation) fetal intrauterine death or medical termination of pregnancy. The use of mifepristone and misoprostol for these clinical indications is thought to be less traumatic for the woman as well as being cost effective and evidence based.

COMPETENCIES REQUIRED All medical staff and appropriately trained experienced nursing staff.

PATIENTS COVERED All women undergoing medical management of mid-trimester fetal intrauterine death or medical termination of pregnancy between 14+0 – 20+0 weeks gestation.

CAUTIONS:  Asthma  Chronic obstructive pulmonary disease  Cardiovascular disease or risk factors  Prosthetic heart valve or history of infective endocarditis (prophylaxis recommended)  Haemorrhagic disorders and anti-coagulation therapy  Adrenal suppression (may require corticosteroid)  Breast-feeding

CONTRA-INDICATIONS:  Uncontrolled severe asthma  Chronic adrenal failure  Not recommended in chronic hepatic or renal impairment  Ectopic pregnancy

GUIDELINE Worcestershire Royal Hospital: Arrange admission to Lavender Gynaecology. Alexandra Hospital: Women with of gestations /= 16+0, arrange admission to delivery suite.

The patient will be referred with the appropriate medical notes and investigation results, via: -  Early Pregnancy Assessment Unit (EPAU)  Ultra Sound Scan Department (USS)  Antenatal Clinic (ANC)  Accident and Emergency (A&E) department

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1. Referral via EPAU, USS or ANC

Patient is seen by department staff and medical staff who will:

(i) Explain the procedure, including the fact that this is an unlicensed indication for misoprostol and answer any questions that patient/relatives may have.

(ii) Provide support and counselling as required, supported by relevant information leaflets and support group contact details.

(iii) Obtain informed consent, complete consent form (including information on the unlicensed use of misoprostol) and get woman to sign. - For termination of pregnancy: Consent form to state “Termination of Pregnancy and induction of labour with mifepristone and prostaglandins. +/- Evacuation of retained products of conception.” - For intrauterine deaths:Consent form to state “Induction labour by prostaglandins +/- Evacuation of retained products of conception.”

(iv) Arrange for blue termination (HSA1 may be blue or white) form to be completed where there is a live foetus. This must be completed and signed by two Doctors in accordance with the 1967 Act. Commence form HSA4 (Yellow form and should be completed at delivery and returned within 14 days). Form to be completed by the doctor performing the termination.

(v) Complete and sign the white form for examination of foetal tissue.

(vi) Complete medical clerking.

(vii) Worcestershire Royal Hospital: Arrange admission to Lavender Gynae. Alexandra Hospital: Women with pregnancies of gestations /= 16+0, arrange admission to delivery suite.

2. Prescribe Regime for Administration

Complete drug chart. (i) Mifepristone 200mg orally (to be given at onset of treatment). then 36 – 48 hours later:

(ii) Misoprostol 800 micrograms per vagina (4x 200microgram tablets).

then: (iii) Misoprostol 400 micrograms (2 x 200 microgram tablets) orally every 3 hours following PV dose until total of 5 doses in 24 hours have been administered (inclusive of the PV dose). (iv) Prescribe analgesia (NSAIDS to be avoided). Paracetamol 1g QDS, co-dydramol 2 tablets QDS as an alternative. Pethidine 50-100mg IM 4 hourly should also be prescribed. (v) Ensure patient has access to inhaled analgesia (Entonox) and, if required, epidural analgesia should be considered. 3. Administration of Oral Mifepristone

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NB: A stock of mifepristone is kept on the ward in the Controlled Drug cupboard. A record is kept in the Controlled Drug register of any stock received on the ward and any doses dispensed to patients. Further supplies of mifepristone should be ordered from pharmacy using the Controlled Drug requisition book. Misoprostol should be available on the ward (it does not need to go in the CD cupboard or be recorded in the CD register). Further supplies can be obtained from the pharmacy using the usual requisition book. (i) Administer oral mifepristone 200mg as per protocol. Patient should be asked to remain on the ward for 20 minutes to be monitored for any vomiting. If she is well after 20 minutes she can be allowed to go home with a full explanation of procedure, what symptoms to expect i.e. bleeding and abdominal pain together with a contact number for the ward which she can ring if she has any concerns. The patient should be advised that she may take mild paracetamol based analgesia (TTOs to be provided) but to avoid NSAIDS. (ii) Record label number of drugs in patient’s notes and sign, date and time this entry. 4. Ensure a bed is blocked on the ward so the patient can return at any time. 5. Instruct patient to return to the ward 36 – 48 hours later to continue the procedure, usually at 0900 hrs. 6. On re-admission to the ward:  Undertake baseline observations recording temperature and BP. Presence of any bleeding or abdominal pain to be discussed with patient and documented. ID wristband and allergy band applied.  Site IV access and take bloods for FBC and Group and Save if this has not already been taken.  Ensure patient understands the procedure and check consent form is signed.

7. Administration of Vaginal Misoprostol

(i) Adminster misoprostol 800 micrograms PV (tablets moisten prior to administration) into posterior fornix. (This can be a nurse-led procedure see Appendix 1).

(ii) Advise the patient to rest on bed for ½ hour following insertion of tablets.

(iii) Commence 2 hourly observations and observe for bleeding and abdominal pain. Document in nursing notes as appropriate.

(iv) The patient may have fluids and light diet.

8. Commence regime of misoprostol 400 micrograms 3 hourly (orally) until 5 doses have been given (inclusive of PV dose).  Have a delivery pack ready for delivery of the foetus.  Continue until foetus is delivered. Cord should be clamped and cut.

9. IM Syntometrine 1 ampoule (1ml) administered at delivery, as prescribed.

 Consider gentle cord traction or requesting patient to push which can assist in the delivery of the placenta.

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 In event that the placenta is not delivered within 45 minutes of the administration of the Syntometrine, assessment by medical staff is required. IV fluids may be commenced. Patient should be nil by mouth. Bleeding and observations monitored. Book theatre for manual evacuation of retained products of conception – book main / CEPOD theatre. Explain the procedure and arrange for consent form to be signed or check that this has been incorporated in the original consent form.

The procedure should be performed by either the gynaecology senior middle grade or gynaecology consultant.

10. In the event of products of conception (POC) not being passed prior to the 5th dose of misoprostol then a PV examination should be performed by the senior middle grade / Gynae Consultant to ensure that POC are not in the vagina and to assess the cervix.

The on-call gynaecology consultant should then be contacted for further management decision of either:  Allow patient to rest for 12 hours following the last administered dose of misoprostol then recommence the misoprostol regime (consider intravenous fluid administration overnight and ensure the patient is aware that products of conception may be passed during the rest period) OR  Commence administration of intravenous oxytocin (Syntocinon) 15iu in 500mls of 0.9% sodium chloride at 64mls an hour for a maximum of 6 hours.

11. When POC are completely delivered patient may then have diet and fluids and needs to stay for a minimum of 2 hours post delivery or 4 hours post opiate analgesia.

12. Management of foetal tissue as per Trust protocol:  Foetal disposal to be completed according to Trust protocol.  Photographs/hand and footprints to be taken as per policy.

13. Check Rhesus status. Anti-D to be given as per Trust protocol.

14. Observations should be as clinically indicated but these should be at least 4 hourly with particular reference to temperature and nurses should be alerted to any signs of infection.

15. Prior to discharge the GP letter should be written. Any antenatal appointment should be cancelled. Follow up to be discussed with the patient and she should have the opportunity to discuss any concerns.

Following the patient being discharged from hospital it is the nurses responsibility to ensure that: -  Any planned USS and antenatal appointments are cancelled.  Miscarriage notification form is completed.  The patient’s G.P and midwife are notified by telephone.  Complete CESDI (Rapid Report Form) and forward to Clinical Midwife Specialist, Lavender Postnatal, WRH.  Arrange consultant follow-up appointment if appropriate  The SHO completes a comprehensive discharge summary for the G.P.

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16. With MTOP in latter stages of the mid-trimester the patient should be told about the potential of the occurrence of lactation and advice given about managing this.

17. Patients should be advised re:(If relevant) Investigations of foetus/placenta – written consent obtained Disposal of products - ?funeral arrangements Bereavement office contacted. Memorial book. Photographs taken and documented. Footprints/Handprints. Miscarriage support groups.

18. If appropriate refer to bereavement issues guideline (WAHT-OBS-061) re further investigations.

MONITORING TOOL

How will monitoring be carried out? Clinical Audit

Who will monitor compliance with the guideline? Gynaecology CG Committee

STANDARDS % CLINICAL EXCEPTIONS All women should have their blood group checked 100% and prescribed Anti-D if appropriate All women undergoing a TOP should have a blue 100% form signed and filed in the notes

REFERENCES

Tewari S. K, Pirwany I. R, Mahmood T.A, Kelleher R. J (1995) Mifepristone in mid trimester termination of pregnancy – value for money? The British Journal of Family Planning 21: 7 – 9

Weeks A. D, Stewart P. (1995) The use of mifepristone in combination with misoprostol for second trimester termination of pregnancy. The British Journal of Family Planning 21: 43 – 44

Lawrie A, Penney G, Templeton A. (1996) A random comparison of oral and vaginal misoprostol for cervical priming before suction termination of pregnancy. British Journal of Obstetrics and Gynaecology. November 1996 Vol. 103 pp 1117 – 1119.

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CONTRIBUTION LIST

Key individuals involved in developing the document Name Designation Miss A Blackwell Consultant Obstetrician-Gynaecologist Rachel Duckett Consultant Obstetrician-Gynaecologist Mr J F Watts Consultant Obstetrician-Gynaecologist/Clinical Director Mr J Uhiara Consultant Obstetrician-Gynaecologist Jackie Fowler Ward Manager (Ward 14) - Alex Jan Chance Ward Manager (Lavender Gynae) - WRH Circulated to the following individuals for comments Name Designation Mr S Agwu Consultant Obstetrician/Gynaecologist Mrs P Arya Consultant Obstetrician/Gynaecologist Mrs S Ghosh Consultant Obstetrician/Gynaecologist Mr J Hughes Consultant Obstetrician/Gynaecology Mr M Labib Consultant Gynaecologist Mr P A Moran Consultant Gynaecologist Miss M Pathak Consultant Obstetrician/Gynaecologist Mr M D Pickrell Consultant Gynaecologist Mr B A Ruparelia Consultant Gynaecologist Mrs J Shahid Consultant Obstetrician/Gynaecologist Miss D Sinha Consultant Obstetrician/Gynaecologist Miss L Thirumalaikumar Consultant Obstetrician/Gynaecologist Mr A Thomson Clinical Director-Consultant Obstetrician/Gynaecologist Liz Walters EPAU Sister - Alex Julie Brassington EPAU Sister - WRH R Fletcher Clinical Pharmacist, WRH C Gibson Clinical Pharmacist, Alexandra Hospital Circulated to the chair of the following committee’s / groups for comments Name Committee / group Alison Smith Medicines Safety Committee

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Supporting Document 1 – Checklist for review and approval of key documents This checklist is designed to be completed whilst a key document is being developed / reviewed.

A completed checklist will need to be returned with the document before it can be published on the intranet.

For documents that are being reviewed and reissued without change, this checklist will still need to be completed, to ensure that the document is in the correct format, has any new documentation included.

1 Type of document Guideline 2 Title of document Medical management of midtrimester fetal intrauterine death or termination of pregnancy using mifepristone/ misoprostol 3 Is this a new document? Yes No If no, what is the reference number WAHT-GYN-001 4 For existing documents, have you Yes No included and completed the key amendments box? 5 Owning department Gynaecology 6 Clinical lead/s Miss M Pathak 7 Pharmacist name (required if Rosie Fletcher/c Gibson medication is involved) 8 Has all mandatory content been Yes No included (see relevant document template) 9 If this is a new document have Yes No properly completed Equality Impact and Financial Assessments been N/A included? 10 Please describe the consultation that Circulated to individuals on the contribution list and has been carried out for this members of the Medicine Clinical Governance Committee document and Medicines Safety Committee 11 Please state how you want the title of Medical management of midtrimester fetal intrauterine this document to appear on the death or termination of pregnancy using mifepristone/ intranet, for search purposes and misoprostol which specialty this document relates to. Once the document has been developed and is ready for approval, send to the Clinical Governance Department, along with this partially completed checklist, for them to check format, mandatory content etc. Once checked, the document and checklist will be submitted to relevant committee for approval.

Implementation Briefly describe the steps that will be taken to ensure that this key document is implemented

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Action Person responsible Timescale Discussed at Gynaecology and Obstetric Governance Miss R Duckett August-Sept Committees Mr P A Moran 2012

Publicise via Effective Handover Miss R Duckett October 2012 Ms K Kokoska

Plan for dissemination

Disseminated to Date Gynaecology and obstetric medical and nursing staff via Effective October 2012 Handover

Step 1 To be completed by Clinical Governance Department 1 Is the document in the correct format? Yes No

Has all mandatory content been Yes No included?

Date form returned 06_/_11__/2012_ 2 Name of the approving body (person Gynaecology Clinical Governance Committee or committee/s) Step 2 To be completed by Committee Chair/ Accountable Director 3 Approved by (Name of Chair/ Mr Paul A Moran Accountable Director): 4 Approval date 14.06.12 (Confirmed by Rachel Duckett, Obstetric Guidelines Lead on 06.11.12)

Please return an electronic version of the approved document and completed checklist to the Clinical Governance Department, and ensure that a copy of the committee minutes is also provided (or approval email from accountable director in the case of minor amendments).

Office use only Reference Number Date form received Date document Version No. published WAHT-GYN-001 06/11/2012 07/11/2012 1

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