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CHHS17/279

Canberra Hospital and Health ServicesClinical Guideline Termination of Pregnancy (TOP), Miscarriage or Fetal Death Management Contents

Contents....................................................................................................................................1

Guideline Statement.................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Assessment.............................................................................................................3

Section 2 – Counselling.............................................................................................................4

Section 3 – Conscientious Objection.........................................................................................4

Section 4 – Surgical Termination of Pregnancy.........................................................................5

Section 5 – Contraindications and Prerequisites to Medical Termination of Pregnancy...........5

Section 6 – Outpatient Management – Administration of mifepristone...................................6

Section 7– Inpatient Admission – Administration of misoprostol.............................................8

Section 8 – Fetocide................................................................................................................12

Section 9 – Post Birth..............................................................................................................15

Section 10 – Registration and Documentation Requirements................................................16

Section 11 – Continuing Care and Follow Up..........................................................................17

Section 12 – Medication Supply, Dispensing and Storage.......................................................18

Implementation...................................................................................................................... 18

Related Policies, Procedures, Guidelines and Legislation.......................................................18

References.............................................................................................................................. 19

Definition of Terms................................................................................................................. 21

Search Terms.......................................................................................................................... 22

Attachments............................................................................................................................22

Attachment 1 – Mifepristone Additional Notes..................................................................23

Doc Number Version Issued Review Date Area Responsible PageCHHS17/279 1 21/11/2017 01/10/2022 WY&C - Maternity 1 of 23

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Guideline Statement

To provide guidelines for the care and management of women who are requesting and/or undergoing a Termination Of Pregnancy (TOP) or medical management of miscarriage or fetal death.

In order to ensure that requirements of the ACT Births, Deaths and Marriages Registration Regulation (1998) are fulfilled: in the case of a stillbirth, where it is unclear whether the gestational age is less than 20

weeks at the time of delivery, the fetus is to be weighed. If the weight is 400 grams or greater the fetus is to be registered as a stillbirth and a death certificate issued

if the gestational age is less than 20 weeks AND the weight is less than 400 grams no birth or death notification or registration is required

any birth at 20 weeks gestation or greater AND/OR any fetus weighing 400 grams or more must be notified and registered

all live births and all deaths following a live birth must be notified and registered.

The medical officer is responsible for the advice, procedure, treatment and care of the woman.

The midwife/nurse acts under the direction of the medical officer at all times when giving or providing medication to a woman.

All women having a termination of pregnancy beyond 23 weeks gestation will be offered fetocide prior to the termination.

Back to Table of Contents

Scope

This document applies to the following Canberra Hospital Health Services (CHHS) staff working within their scope of practice: Medical officers Registered Midwives and nurses Students under direct supervision Allied health professionals and Pastoral carers


Section 1 – Assessment



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Assessment of need is undertaken by the medical officer in consultation with the woman after appropriate investigations, clinical assessment, psycho-social assessment and counselling have occurred.

The clinician must ensure a full clinical workup has been completed and documented in the woman’s medical record and the appropriate specialist consultations have occurred (e.g. geneticist, paediatrician, psychiatrist). Documentation of any Fetal Medicine Unit (FMU) reviews should also be entered into the woman’s medical record.

The treating medical practitioner must obtain and document the woman’s consent in accordance with the ACT Health Consent and Treatment Policy.

A Termination Review Committee (TRC) review must be sought prior to performing any termination of pregnancy at 20 weeks or more gestation. The exception to this is where the following conditions exist: Trisomy 13 or Trisomy 18 or Anencephaly or Triploidy.

The TRC provides a multidisciplinary forum to: support the clinical team when caring for a women requesting termination provides a central point for review of requests for termination determines whether all relevant reports and results have been obtained and are

available to the woman and clinical team to assist decision making, and seeks further information as needed.

Membership of the Committee consists of: Clinical Director of Obstetrics and Gynaecology (or delegate) Social Worker Neonatologist Clinical Midwife Consultant, Birthing (or delegate) Genetic Counsellor or geneticist Other clinicians who may provide information relevant to the condition of the woman or

fetus e.g. Nephrologist, Psychiatrist or mental health specialist, Peadiatrician or specialist in fetal medicine.

The Chair of the committee (usually the Clinical Director of Obstetric and Gynaecology or delegate) determines the membership of the Committee each time it is convened.

The referring clinician is to ensure a request for TRC review is completed and forwarded to the TRC for consideration, through the Office of the Director of Obstetrics and Gynaecology, Centenary Hospital for Women and Children.



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TRC meetings are convened within three (3) business days of the request being received.


Section 2 – Counselling

All women must be offered counselling by either a social worker or psychologist prior to the procedure. This counselling is in addition to any genetic counselling that may be indicated.

Pre and post test and /or procedure counselling and evidence of counselling by a medical practitioner and/or social worker must be documented in the woman’s medical record and made available to the treating medical officer.

Referral to a social worker for advice and support in arranging cremation or burial post treatment, should be offered to the woman if treatment will result in the birth of a stillborn baby (specified by the Births, Deaths and Marriages Registration Act 1999) of 20 weeks or more gestation, or a body mass of 400 grams.

For babies less than 400grams or 20 weeks gestation, there is no legal requirement for birth registration or burial. However, parent’s wishes for their baby, whether that be a private burial/cremation or disposal by the hospital, can be arranged through the social worker and pastoral care support services.

Staff counselling is available if requested or required through the Employee Assessment Program on 1300 361 008 (available 24 hours/7 days a week).


Section 3 – Conscientious Objection

A medical officer who objects to being involved with terminations must inform the woman they have a conscientious objection and that another practitioner will care for her and refer the woman to a medical officer who performs the procedure.

Health Professional staff with a conscientious objection to TOP should notify their manager in a timely manner of their objection.

Section 84 of the Health Act states that no-one is under a duty to carry out or assist in carrying out a termination , and a person is entitled to refuse to assist in carrying out a termination.

This excludes performing a TOP or any pre, intra or post TOP care in an emergency situation. Medical officers, midwives and nurses must perform a TOP and/or provide pre, intra or post procedure care in those rare emergency cases where it is necessary to preserve the life of the pregnant woman regardless of their personal objections.



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Section 4 – Surgical Termination of Pregnancy

All surgical terminations are to be booked via Surgical Bookings using a Request for Admission (RFA) form.

If a woman requires additional medical care she will be admitted to the Acute Care Unit.Surgical terminations must be booked for Monday to Friday, 8am - 5pm.


Section 5 – Contraindications and Prerequisites to Medical Termination of Pregnancy

Contraindications and Caution to medical termination of pregnancy requiring careful assessment before induction of labour is undertaken Bleeding conditions or concomitant administration of anticoagulants inherited porphyria chronic or acute adrenal, renal or hepatic failure chronic corticosteroid use (as mifepristone suppresses adrenal function for three to four

days due to its competitive antagonism at glucocorticoid receptors) intrauterine device in situ pelvic infection known or suspected ectopic pregnancy severe asthma requiring corticosteroids cardiac disease significant anaemia poorly controlled seizure disorder

Contraindications to mifepristone: known allergy to mifepristone adrenal insufficiency steroid dependent cancer

Contraindications to misoprostol: allergy to prostaglandins known allergy to misoprostil bleeding disorders or concurrent anticoagulation therapy

Prerequisites to Treatment It is the woman’s preference no active bleeding or infection support at home and reliable transport available access to a telephone



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lives within one hour travelling time of emergency medical care willing to participate in follow-up in one to two weeks post-partum

o Ensure that : the woman is aware of the risk of pain and bleeding at home the woman has contact details/plan for emergency care the woman is aware of uncertain time frame and possible need for later/urgent

curettage

Clinical History Date of last menstrual period pregnancy test – type and timing ultrasound or vaginal examination to assess the site and gestation of the pregnancy symptoms of pain and bleeding history of previous pregnancies / uterine surgery e.g. caesarean section any medical conditions and allergies counsel the woman appropriately all women should be given accurate written information about treatment.


Section 6 – Outpatient Management – Administration of mifepristone

Consent and AdviceAt the time of booking the mid-trimester induction of labour (i.e. prior to admission), the doctor must: Ensure that the woman has no contraindications to medical induction of labour Carefully explain, using an interpreter where necessary, the relevant information for a

medical induction of labour in the second trimester using mifepristone and misoprostol, in particular noting: o the special prescribing information regarding misoprostol (off-license use) o the possible complications and side-effects of the process

Alert: In case of a live baby, the woman should be certain of her decision before commencing the process; should she change her mind after the mifepristone is given, serious injury to the fetus is possible

Advise the woman that after taking mifepristone she may experience mild and transient side effects such as: headache cramping nausea vomiting she should be advised that simple analgesia such as paracetamol and / or antiemetics

may be used.



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if the symptoms are severe she should contact the hospital with a view to an earlier admission.

Advise the woman that after commencing misoprostol she may experience: pain - Paracetamol or Non steroidal anti-inflammatory drugs (NSAID)s can be taken fever ≥ 38 degrees with or without shivering. (This is a misoprostol effect which settles

shortly after misoprostol therapy finishes and does not require antibiotic therapy. It should be distinguished from fever occurring more than 24 hours after misoprostol therapy is complete which may indicate infection and require treatment)

diarrhoea which settles soon after the final misoprostol nausea and vomiting (anti emetics can be prescribedto manage this) the need to go to the operating theatre to remove a retained placenta blood transfusion(same risk as birth at term) rare serious complications

o major abdominal surgery (same risk as birth at term) o loss of the uterus (same risk as birth at term) o death from childbirth (same risk as birth at term) o death from rare bacterial infection with Clostridium sordellii (1 woman per 100,000

probably related to mifepristone effect) Advise the woman about the duration of labour from the first misoprostol dose in

hospital: o Gestation less than 18 weeks and a previous vaginal birth:

median duration of labour 6 hours (half will be faster and half slower than this) proportion undelivered after 24 hours 2%

o Gestation more than 18 weeks and no previous vaginal birth: median duration of labour 12 hours (half will be faster and half slower than this) proportion undelivered after 24 hours 5% (2 – 8%).

Note: Third trimester labour duration is often considerably longer than these figures, especially for nulliparous women.

Ensure that the: consent is signed and filed in the medical record (it is not necessary for a copy of the

consent to be sent to pharmacy with the prescription). information Section of the Consent papers is given to the woman to take home. ensure woman has received the Mifepristone / Misoprostol Induction of Labour

Information sheet for women. if misoprostol is required, organise for a return presentation to hospital for the woman

thirty-six to forty-eight hours after administration of mifepristone. provide written information as to when and where to return to hospital.

mifepristone 200Mg PO x 1 tablet, dispensed by the hospital pharmacy Instruct the woman to take the mifepristone:



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on an empty stomach i.e. 2 hours after food and then not to eat for another 2 hours after taking it

consider giving another dose if the woman vomits within an hour of mifepristone ingestion.

The ideal mifepristone-misoprostol time interval is 36 – 48 hours and will usually be prescribed as it: optimises the mifepristone effect in sensitising the myometrium to the action of

prostaglandins is associated with a labour that is several hours shorter than when a 24 hour mifepristone-misoprostol interval is used especially for women with a gestation > 16 weeks and without a previous vaginal birth.

The the interval can be varied by a consultant, if necessary, after consideration of the woman and her circumstances.


Section 7– Inpatient Admission – Administration of misoprostol

Admission As the admission for induction must occur at a specific time after mifepristone administration, the Birthing Team Leader must be notified and the induction booked in the induction calendar. The woman must be provided with clear instructions as to when she needs to return.

Ensure written consent for use of misoprostol as per Consent and Treatment Policy insert intravenous (IV) cannula and collect blood samples for FBC and group and save ensure appropriate medication is charted

Medications Misoprostol (see below for dosages) Analgesia

o non steroidal anti inflammatory medication e.g. Diclofenac 50Mg Per Oral(PO) 3 times a day (tds) as required (prn)

(Contraindicated if allergy or severe adverse reaction to previous therapy with NSAIDS/aspirin see MIMMS)

liberal NSAIDs early in the induction process may significantly reduce the need for subsequent narcotics.

Note: NSAIDs interrupt the synthesis of natural prostaglandins (PGs). They do not reduce the efficacy of administered PGs and do not prolong the labour process.

o Morphine 5 – 10 Mg subcutaneously every 3 hours (q3h) prn.



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(Contraindicated if hypersensitive to opiates and in serious CNS/lung/cardiac disorders. May cause sedation, nausea/vomiting and constipation).

A patient controlled analgesia (PCA) infusion of narcotic may be very useful, especially in longer labours associated with advanced gestations and no previous vaginal birth (note: a PCA must not be given if an anxiolytic has been administered). Occasionally, an epidural may be required.

AntiemeticsE.g. Metoclopramide 10 Mg intravenously (IV) / intramuscular (IM) every 4 hours (q4h) prn. (Contraindicated if known hypersensitivity to the drug. May cause sedation).

Oxytocin 10 International Units (IU) IM to be given with birth of the baby (as occurs at term).

Rh D Ig 625IU IM if woman Rh D negative Other Medications which may be needed:

o Cabergoline 1 Mg stat PO with food is to be offered after births > 18 weeks as 50% of these women will suffer moderate and 30% severe breast pain due to engorgement. It should be given within 12 hours of birth for maximal efficacy. Contraindications include severe preeclampsia, uncontrolled severe hypertension (SBP ≥ 150mmHg, DBP ≥ 100 mmHg), sensitivity to ergot preparations, ischaemic heart disease, severe peripheral vascular disease, Raynaud’s Syndrome.

o anxiolytic such as Lorazepam 1 – 2 Mg PO every 6 hours (q6h) prn may be required. It should not be prescribed routinely, only after assessment of the individual woman’s needs. NOTE: anxiolytics must not be given in conjunction with PCA narcotics as serious respiratory depression may occur.

Observations Ensure height, weight and Body Mass Index (BMI) are documented perform the following observations before commencing procedure, then 3 hours after or

more frequently if clinically indicated.When labour is established, observations are to be recorded hourly: o temperature o pulse o respirations o uterine activity o vaginal loss o record an accurate fluid balance chart.

Diet: Full diet until onset of contractions clear fluids after onset of contractions fast once membranes have ruptured and remain fasting until placenta delivered and

declared complete.

Alerts:



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Oral misoprostol is less effective than vaginal misoprostol for induction of labour for termination in the second and third trimesters of pregnancy for fetal anomaly or following intra-uterine fetal demise. Women experience longer induction to birth, with increased chance of remaining undelivered 24 hours after the induction process commences.

In women with a previous caesarean lower doses should be used and dose doubling should not occur.

If a woman has more than one uterine scar, a delivery plan is to be made by the consultant obstetrician gynaecologist. See specific dosage requirements.It is a consultant decision for oxytocin augmentation in the presence of a uterine scar (RCOG; FIGO).

offer and arrange follow-up referrals with allied health professionals as appropriate for gestation and situation (e.g. Fetal Medicine Unit (FMU), Early Pregnancy Assessment Unit (EPAU), Grief and Loss Counsellor, Social Work, Pastoral Care, Genetics)

administer misoprostol per vagina (PV) or orally according to the following table.

Doses in women with intact uterusGestation Loading dose Subsequent dose Live fetus Subsequent dose IUFD<7 400 micrograms

(mcg) sublingual (SL)

7-9 800mcg per vaginal (pv)/SL

9-13 800mcg 200mcg 3 hourly x 4 doses 200mcg 3 hourly x 4 doses 13-17+6 400mcg 200mcg 3 hourly x 4 doses 100mcg 6 hourly x 4 doses18-24 400mcg 200mcg 3 hourly x 4 doses 50mcg 6 hourly x 4 doses 24+1-27+6 omit 200mcg 3 hourly x 5 doses 50mcg 6 hourly x 4 doses

Doses in women with a previous caesarean section / uterine scarGestation Loading dose Subsequent dose Live fetus Subsequent dose IUFD<7 400mcg SL7-9 800mcg pv/SL9-13 800mcg 200mcg 3 hourly x 4 doses 200mcg 3 hourly x 4 doses 13-17+6 400mcg 200mcg 3 hourly x 4 doses 100mcg 6 hourly x 4 doses18-24 400mcg 200mcg 3 hourly x 4 doses 50mcg 6 hourly x 4 doses 24+1-27+6 omit 200mcg 3 hourly x 5 doses 50mcg 6 hourly x 4 doses 28-43 omit 50mcg 4 hourly x 5 doses 25mcg 4 hourly x 6 doses

Note: mifepristone 200Mg orally followed by misoprostol is effective and appropriate at any

gestation mifepristone is given 36-48 hours prior to misoprostol first dose should be Per Vagina (PV). Subsequent doses ideally PV although sub lingual

(SL) is a reasonable alternative if heavy vaginal loss or for patient/staff reasons



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from 24 + 1 weeks (increased misoprostol sensitivity SL or PV) o no misoprostol loading dose o much smaller doses o even smaller for deceased baby and uterine scar o half dose for women with previous scar less than 28 weeks. The risk of uterine

rupture is about 0.4% with 1 prior low segment caesarean section, and up to 50% with prior vertical caesarean delivery

o for those with previous low segment caesarean section after 28 weeks with unsuccessful first course of mifepristone-misoprostol protocol, oxytocin may be utilized and cervical ripening with foley catheter may be considered.

o for those who had fetocide <48hours earlier use the same misoprostol dose regimen as with a live fetus

women undelivered with this regimen o more than 95% of women will deliver within 24 hours with this regimen, most within

15 hours. o Women who have not delivered must be reviewed by a consultant or a registrar in

close communication with a consultant. Rest woman overnight and recommence regimen the following day. do not administer the loading dose again. Commence with the subsequent dose

as in the table above consider a repeat dose of mifepristone after two days of misoprostol treatment alternative regimens include oxytocin or surgical evacuation of the uterus.

Retained Placenta / Placental fragments this will occur in up to 30% of cases although there is evidence that the rate can be

reduced to 10% if oxytocin 10units IM is given immediately after the birth of the fetus as occurs with birth at term.

Should the placenta be retained for 60 minutes, a speculum examination should occur. o the placenta is commonly in or just above the cervix where it can easily be removed

using sponge forceps. The need for manual removal in operating theatres (OT) can be significantly reduced by this approach

o good lighting, an assistant and a bed with a drop end must be made available for this procedure

Should removal of the placenta be unsuccessful with this manoeuvre the woman should be transferred to the operating theatre for removal o oxytocin may be infused at 10 units per hour while awaiting transfer to the operating

theatre (40units in a 1000mL flask of Hartmanns run at 250 mL per hour). retained placenta is a risk factor for heavy bleeding and blood transfusion. Urgent

management should be undertaken if heavy bleeding occurs.

Side effects from mifepristone and misoprostol shivering, chills, diarrhoea, hot flushes, abdominal pain and low grade temperatures if temperature is greater than 38˚C and uterine infection is suspected please refer to the

Therapeutic Guidelines for treatment of severe non-sexually acquired pelvic infection for choice of antibiotic



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nausea and vomiting headache occasional pelvic cramping prior to admission pelvic infection (rare) or systemic infection.


Section 8 – Fetocide

Patient Preparation The patient must be comfortable and relaxed maternal sedation is not generally required but should be considered in selected cases

(see Clinical Practice section below)

ConsentThe patient is to be counselled extensively prior to the procedure. On the day of the procedure, the procedure is again fully explained to the patient, and all questions answered. The patient should be made aware of: risk of procedure related miscarriage of remaining fetus (es) if applicable risk of preterm birth risk of unintended outcomes – the risk of wrongful fetocide in a complex higher order

gestation is about 0.5 - 1% other options: expectant management with close surveillance

Equipment Trans-abdominal (TA) transducer (disinfected or covered) suitable system pre-set sterile tray with basic dressing pack

o sterile drapes (feeder pack) o chlorhexidine solution (5% chlorhexidine in alcohol 70%) o 22g spinal needle* o 20 mL syringe o local anaesthetic (1% lidocaine ( lignocaine)) in 5mL syringe and 23g needle o minimum volume extension tube, o 10 mL syringe with potassium chloride (10mmol in 10mL)o sterile probe cover (as required)o sterile gloves

* Spinal needles are 90mm. In some instances Echotip amniocentesis needles (150mm) may be required.

MedicationAlert: High risk medicines are used as part of this procedure. Inadvertant administration of concentrated potassium chloride or rocuronium to the woman may have devastating consequences. A pre-pack of 3 ampoules of 10 mmol potassium chloride will be dispensed



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by Pharmacy specifically for the procedure. Any remaining potassium must be disposed of in a sharps bin immediately on completion of the procedure.

lidocaine (lignocaine) 2%, 2-3 5mL ampoules (for maternal analgesia and fetal injection as required)

potassium chloride (KCl) concentrate 10 mmol (0.75g) in 10 mL. rocuronium (50 Mg in 5mL for fetal paralysis as required) morphine 10 Mg/1 ml (for fetal analgesia as required) midazolam 5 Mg in 5 ml (for maternal intravenous (IV) sedation as required)

Clinical practice Counsel woman with specialist and FMU midwife with regard to potential clinical options ensure woman has met with Social Worker and/or other appropriate support services as

required ensure hospital termination review process is complete if required in some cases women may be offered or require sedation for the procedure: IV

midazolam 1Mg aliquots to a maximum of 5 Mg. Advise the woman that she may not recall the procedure if she chooses this option and maternal monitoring may be required

arrange appropriate follow-up after the procedure (admission or follow up with midwife, obstetrician, social work or mental health worker).

post procedure recommendations including information to explain what can be expected and how to make contact with the unit in case of any concerns.

ProcedureAlert:In the case of selective reduction in a multiple pregnancy it is important that both the clinician(s) and/or sonographer, perform a baseline ultrasound prior to the procedure to accurately identify the fetus to be terminated Fetocide is performed transabdominally the FMU midwife is usually the support person and assistant with the procedure (set-up

and verification) in addition to the team involved with the procedure a sonographer scans while the specialist performs the procedure or the responsible

clinician can scan and insert the needle ideally, the specialist involved in diagnosis and counselling is the same one as performing

the procedure using aseptic technique, local anaesthetic is injected into tissue above the uterus under

ultrasound guidance the specialist may decide to reduce amniotic fluid volume prior to inserting the needle

into the fetus (under ultrasound guidance as per amniodrainage) consider the use of rocuronium 50Mg/5mL for fetal paralysis

o less than 30 weeks gestation 2 Mg = 0.2mLs by injection (intramuscular) IM into fetus

o greater than 30 weeks gestation 3 Mg = 0.3mL by injection IM into fetus



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consider the use of intra-muscular morphine to the fetus for analgesia in gestations of 24 weeks and above at a dose of 100 mcg/kg

the spinal or echotip needle is inserted into the fetal heart under ultrasound guidance aspirate fetal blood to confirm correct needle placement into the fetal heart. Potassium

chloride (KCl) and /or lignocaine is then injected

Note:The following doses are a guide when using KCl: first trimester 1 – 2 mmol KCl second trimester 5 mmol KCl third trimester 10 mmol KCl

watch for asystole, inject further KCl if required when asystole is confirmed all needles are removed review for asystole again 10-15 mintues after completion of the procedure administer Anti-D IM if indicated

Imaging Baseline (pre procedure) images to demonstrate the correct fetus for the procedure has

been correctly identified (if applicable) document needle placement document absence of fetal cardiac motion immediately post procedure and 10-15

minutes later document presence of fetal cardiac motion in other fetus(es)(if applicable) immediately

post procedure and 10-15 minutes later

Documentation medication chart integrated clinical notes antenatal record card Viewpoint report


Section 9 – Post Birth

Post-birth care Check feto/maternal haemorrhage (FMH) test prior to Anti-D administration administer Rh(D) Immunoglobulin 625 IU in women who are Rh negative follow up FMH to ensure adequate Anti-D has been administered label the baby with two name tags (if ankles inappropriate due to size attach label

around abdomen) also place the Medical Record Number (MRN). Babies <20 weeks will not have a MRN and are identified by the maternal MRN label on the outside of the blankets

offer parents ample time to be alone with their baby



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always obtain permission to take photos, foot and handprints (even when parents do not want to take the photos with them). Explain that photos will be stored in the medical record as per the Photo, Video and Audio: Capture, Storage, Disposal and Use procedure and Perinatal Loss – Clinical and Bereavement Digital Images procedure.

mementoes not taken by the parents will be placed in a clearly marked box and passed to the Perinatal Loss Coordinator

the baby can stay in Birthing as long as the parents want until they are ready for the baby to be taken to the mortuary. If the parents want the baby to be taken away for a time but not to the mortuary, the baby can be placed in the “Cuddle Cot” or in the mortuary fridge in room 14.

to ensure the where abouts of the baby is known and recorded the baby’s details are to be registered in the Room 14 mortuary fridge register. The where abouts of the baby to be recorded both in and out of the register as requested by parents.

Parents are informed when their baby will be moved from the room 14 fridge to the Mortuary

Mortuary register will reflect ALL babies transferred to the Mortuary

Post mortem examination/autopsy and disposal of bodyBabies < 20 completed weeks Offer post mortem examination and obtain parental consent if postmortem examination

is desired send baby to histopathology for post-mortem examination. The baby may be returned to

the woman after testing, if requested if the parent’s wish, histopathology can arrange for cremation and then for the ashes to

be sent to the Rose Garden at either Woden or Gungahlin cemeteries Alternatively parents may choose a private funeral and burial

Babies > or = 20 completed weeks The midwife or medical officer is to offer a post-mortem autopsy. The medical officer is

to obtain the parents written consent, complete with detailed history, arrange the autopsy and contact pathology to discuss plan for post-mortem autopsy

the baby must be registered as either a stillborn baby or a neonatal death in accordance with death registration requirements stated in Section 10 of this document

private cremation or burial of stillborn baby is arranged by the family the social worker should be contacted to help with the arrangements as per the

pregnancy loss pathway. See Section 2 - Counselling of this procedure for more information.

Responsibilities for transfer of baby to and from the mortuary Deceased babies are collected to be taken to the mortuary by mortuary personnel during

office hours Funeral Directors usually collect babies from the mortuary, however if the parents

choose, the baby can remain with them until transfer. This can be arranged following discussion with the mortuary staff



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Families who live in the surrounding region may choose to transport the baby to their home town for burial. Coffins are available in the Angel Room for this purpose. Arrangements need to be made in advance with the local area funeral director.


Section 10 – Registration and Documentation Requirements

Medical officer documentation requirements: To ensure compliance with the ACT Coroners Act 1997, the Deceased Persons Checklist

must be completed by the Medical Officer on all deaths pronounced at Canberra Hospital. This is available on the Clinical Forms Register on the ACT Health intranet

All terminations where the fetus is of greater than 20 weeks gestation are to be registered. Those that show signs of life are to be registered as a neonatal death otherwise the birth will be registered as a stillbirth

In the case of a stillbirth where it is unclear whether the gestational age is less than 20 weeks at the time of delivery the fetus is to be weighed, if the weight is 400 grams or greater the fetus must be registered as a stillbirth.

The following must also be completed:If <20 completed weeks For all babies <20 completed weeks gestation complete the “To Whom it May Concern”

(In blue folder, kept in Angel Room in Birthing), unless the baby is for a private burial

If > or = 20 completed weeks the Medical Certificate of Cause of Perinatal Death Form B.

For all gestations: Request and Permission for Post mortem Examination form (accessible on the ACT

Health intranet- Clinical Forms Register) Certificate of Medical Attendant, this form is for cremation for any baby who takes a

breath (irrespective of gestation).

The midwife will complete:>20 weeks Pregnancy Loss Clinical Pathway Birthing Outcomes System (BOS) Birth summary, fax completed form to FMU. FMU will arrange a follow up appointment Birth registration Centrelink ‘Claim for Bereavement Payment’ form (page 24) complete, print and sign x 2 the BOS discharge summary. One copy is to be given to the

woman and the other copy filed in the notes. an ACT Confidential Report on Perinatal Death form is completed for all terminations of

pregnancies with fetal abnormalities and fetal death in utero (FDIU) in the 2nd and 3rd trimesters. The form is still completed If the baby’s gestation is unknown and birth



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weight is 400g or more. This form is to be forwarded to the BOS Perinatal Systems Officer.

All documentation related to <20 weeks must be given to the Birthing Ward Clerk (photocopy documents: originals to ward clerk, copy in the notes).

All gestations: Application For Burial or Cremation of Fetal Remains (for all stillbirths or Rose Garden

<20 weeks). This is completed for any baby that does not breathe (heart rate not relevant) (in blue folder, kept in Angel Room in Birthing). This is available on the intranet.


Section 11 – Continuing Care and Follow Up

Explain to the woman (particularly if going home early ) that her milk may still ‘come in’ and how upsetting this may be. Offer care regarding suppression of lactation as per the Breastfeeding Clinical Guideline

discuss postnatal self care about lochia and ‘after pains’ and the need for assessment if her temperature is elevated or loss is heavy.

provide the woman with a copy of her Birthing Outcomes System (BOS) and Delivery Summary.

offer and discuss family planning use after completion of termination of pregnancy. refer the woman to Midcall or to her continuity midwife (Continuity at Centenary

Hospital (CatCH) program) for follow-up care at home. check with the social worker involved whether there is to be follow up from the Social

Work Department arrange a follow up appointment in the Perinatal Loss Clinic in Fetal Medicine Unit (FMU)

by contacting the FMU midwife via email [email protected]. notify the woman’s General Practioner (GP) to inform them of the babies demise and

arrange an appointment with the GP within two weeks. give miscarriage information and Red Nose telephone number for support and advice as

required. notify the antenatal education team of fetal demise to prevent phone calls from them to

the family and cancel any further antenatal appointments and classes booked for this pregnancy.


Section 12 – Medication Supply, Dispensing and Storage

All mifepristone prescriptions, as well as inpatient misoprostol administration orders must be prescribed by a consultant registered with the MS Health MS2Step

pharmacists are only eligible to dispense mifepristone prescriptions if they are registered with the MS2Step program

all mifepristone stock will be kept within the hospital pharmacy department



mailto:[email protected]

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Mifepristone prescriptions must be dispensed and supplied to individual patients. Any unused medication must be returned to pharmacy at the earliest convenience.


Implementation

This guideline will be: distributed to maternity staff via email available on Sharepoint discussed at unit meetings, inservice and multi-disciplinary education.


Related Policies, Procedures, Guidelines and Legislation

Policies CHHS Consent and Treatment Policy Health Directorate Nursing and Midwifery Continuing Competence Policy CHHS Medication Handling Policy

Procedures CHHS Maternity - Anti D Procedure CHHS Maternity - Fetocide Procedure CHHS Photo, Video and Audio: Capture, Storage, Disposal and Use procedure Perinatal Loss – Clinical and Bereavement Digital Images procedure CHHS Healthcare Associated Infections procedure

Guidelines Breastfeeding Clinical Guideline

Legislation ACT Births, Deaths and Marriages Registration Regulation 1998 Crimes (Abolition of Offence of Abortion) Act 2002 Medicines, Poisons and Therapeutic Goods Act 2008 Human Rights Act 2004


References

1. ACT Governemnt (1999) Births, Deaths and Marriages Act.2. American College of Obstericians and Gynaecologists (ACOG) (2003) committee opinion.

New U.S. food and drug administration labelling on Cytotec® (misoprostol) Use and Pregnancy, Int J Gynecol Obstet; 82:137- 38.



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3. American College of Obstericians and Gynaecologists (ACOG) (2009). Management of stillbirth. ACOG Practice Bulletin No. 102. Obstet Gynecol; 113 (3): 748-761.

4. American College of Obstericians and Gynaecologists (ACOG) (2009). Induction of labor. ACOG Practice Bulletin No. 107. Obstet Gynecol; 114(2 pt 1): 386-397.

5. Australian government Department of Health and Aging Therapeutic Good Administration – Registration of mifepristoneLinepharma (RU486) and GyMiso (misoprostol) 2012: https://www.tga.gov.au/behind-news/registration-mifepristone-linepharma-ru-486-and-gymiso-misoprostol

6. Australian Medicines Handbook (2015) Misoprostol for obstetric use7. Australian Medicines Handbook (2015) Mifepristone for obstetric use 8. Bartley, J. and D.T. Baird (2002). A randomised study of misoprostol and Gemeprost in

combination with mifepristone for induction of abortion in the second trimester of pregnancy. British Journal of Obstetrics and Gynaecology, 109: 1290-1294.

9. Berghella V, Airoldi J, O’Neill AM, et al (2009). Misoprostol for second trimester pregnancy termination in women with prior caesarean: a systematic review. BJOG; 116 (9): 1151-1157.

10. Carbonell JL, Gallego FG, Llorente MP, Bermudez SB, Sala ES, González LV, Texido CS. (2007) Vaginal vs. sublingual misoprostol with mifepristone for cervical priming in second-trimester abortion by dilation and evacuation: a randomized clinical trial. Contraception; 75: 230-37.

11. Dickinson JE, Brownwell P, McGinnis K, Nathan EA (2010). Mifepristone and scond trimester termination for fetal abnormality in Western Australia: worth the effort. ANZJOG;50:60-64.

12. Dickinson, J, Jennings, B,Doherty D (2014). Mifepristone and Oral, Vaginal or Sublingual Misoprostol for Second Trimester Abortion: A Randomized Controlled Trial. Obstetrics and Gynaecology Journal. - Volume 123:1162-1168.

13. Dodd J, O’Brien L, Coffey J (2005). Misoprostol for second and third trimester termination of pregnancy: a review of practice at the Women’s and Children’s Hospital Adelaide Australia. ANZJOG;45:25-9.

14. Evidenced-based Clinical Guidelines Number 7 (2011). The Care of Women Requesting Induced Abortion. November

15. Fiala, C. and K. Gemzell-Danielsson (2006). Review of medical abortion using mifepristone in combination with a prostaglandin analogue. Contraception, 74(1): 66-86.

16. Fiala C, Swahn ML, Stephansson O, Gemzell-Danielsson K (2005). The effect of non-steroidal anti-inflammatory drugs on medical abortion with mifepristone and misoprostol at 13-22 weeks gestation. HumRep;20(11):3072-7. Goldstone P, Michelson J,

17. Hamodah H, Ashok PW, Flett GM, Templeton A (2004). A randomized controlled comparison of sublingual and vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion. AJOG ; 190: 55-9. www.ncbi.nlm.nih.gov/pubmed/14749635

18. Lalitkumar, S., M. Bygdeman and K. Gemzell-Danielsson (2007). Mid-trimester induced abortion: a review. Human Reproduction Update, 13(1): 37-52National institute for Health and Care Excellence (2013) Nice advice. Induction of labour in late intrauterine ‘fetal death: vaginal misoprostol (after oral mifepristone)



https://www.tga.gov.au/behind-news/registration-mifepristone-linepharma-ru-486-and-gymiso-misoprostol

https://www.tga.gov.au/behind-news/registration-mifepristone-linepharma-ru-486-and-gymiso-misoprostol

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19. Mentula M, Suhonen S, Heikinheimo O (2011). One and two day dosing intervals between Mifepristone and Misoprostol in Second Trimester Medical Termination of Pregnancy – A randomized trial. Human Reproductive; 26(10):2690-2697

20. Nilas L, Glavind-Kristensen M, Vejborg T, Knudsen UB (2007). One or two day mifepristone-misoprostol interval for second trimester abortion. ActaOG Scand;86:1117-1121.

21. Pasquini L, Pontello V, Kumar S (2007). Intracardiac injection of potassium chloride as method for feticide: experience from a single UK tertiary centre. BJOG;115:528-31.

22. Rose SB, Shand C, Simmons A (2006). Mifepristone and misoprostol-induced mid-trimester termination of pregnancy: a review of 272 cases. ANZJOG;46:479-485.

23. Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG (2009)). The use of mifepristone for medical termination of pregnancy. College Statement C-Gyn 21.

24. RANZCOG College statement C-Obs_12. The use of misoprostol in obstetrics and gynaecology

25. Royal College of Obstetricians and Gynaecologists (2011) Evidence based clinical guideline number 7: The care of women requesting induced abortion

26. Royal College of Obstetricians and Gynaecologists (RCOG) (2004). The care of women requesting induced abortion: Evidence-based Clinical Guideline Number 7. London: RCOG Press.

27. Royal College of Obstetricians and Gynaecologists (RCOG), (2010). Late Intrauterine Fetal Death and Stillbirth. Green-top Guideline 55.

28. Royal College of Obstetricians and Gynaecologists (RCOG) (2006). The management of early pregnancy loss. Clinical Green Top Guideline No 25. London: RCOG Press.

29. Royal Hobart Hospital (2014) Mifepristone and misoprostol for medical management of miscarriage or fetal death and for termination of pregnancy

30. Royal Womens Hospital Clinical Guideline, termination of pregnancy-choice of method 31. Sarkar NN (2002). Eur J Obstet Gynecol Reprod Biol. Mar 10;101(2):113-2032. Senat MV, Fischer C., Bernard JP, Ville Y. (2003) The use of lignocaine for use of late

termination of pregnancy. BJOG; 110:296-300.33. Shelley JM, Healy D, Grover S (2005). A randomised trial of surgical, medical and

expectant management of first trimester spontaneous miscarriage. ANZJOG; 45:122-127. 34. Society of Family Planning (2010). Induction of fetal demise before abortion. 2010.

Contraception doi:10.1016/j.01.018.35. Swahn ML, Bygdeman M (1988). The effect of the antiprogestin RU486 on uterine

contractility and sensitivity to prostaglandin and oxytocin. BJOG;95:126-34 36. Tang OS, Thong KJ, Baird DT (2001). Second trimester medical abortion with mifepristone

and gemeprost: a review of 956 cases. Contraception;64:29-32 37. Vauzelle C, Beghin D, Cournot MP, Elefant E (2012). Birth defects after exposure to

misoprostol in the first trimester of pregnancy: prospective follow-up study. ReprodToxicol

38. Wagaarachchi PT, Ashok PW, Smith NC, Templeton A (2002). Medical management of early fetal demise using sublingual misoprostol. BJOG: an Int J Obstet Gynaecol. 109: 462 – 65.



https://www.ncbi.nlm.nih.gov/pubmed/11858883

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39. Webster, D., G. Penney and A. Templeton (1996). A comparison of 600 and 200Mg mifepristone prior to second trimester abortion with the prostaglandin Misoprostol. British Journal of Obstetrics and Gynaecology, 103: 706-709.

40. Williamson E. (2012) Early medical abortion using low-dose mifepristone followed by buccal misoprostol: a large Australian observational study. Med J Aust; 197:282-286.

41. Women’s Hospital Australasia (2008) Management of Early Pregnancy Loss clinical practice guideline March.


Definition of Terms

Termination of pregnancy (TOP): to intentionally remove a fetus and placenta from the uterus causing the termination of a woman’s pregnancy by medical and/or surgical means.

Medical TOP: the administration of medications (e.g.: mifepristone and misoprostol) to terminate a pregnancy by a suitably qualified medical practitioner.

Surgical TOP: the termination of a pregnancy by surgical procedure/s (e.g.: by dilatation and curettage) by a suitably qualified medical practitioner.

Termination Review Committee (TRC): A multidisciplinary panel of suitably qualified staff convened to provide guidance for the care of women requesting a TOP beyond 20 weeks gestation for fetal and/or maternal conditions.

MS Health: A not for profit pharmaceutical company established to deliver vital reproductive health products and medicines.

Nulliparous – a woman who has not yet given birth

Lochia – the liquid discharged from the uterus after childbirth


Search Terms

Termination of pregnancy, TOP, STOP, miscarriage, Fetal death, Misoprostol, Mifepristone, D&C, Miscarriage, Stillbirth, fetocide


Attachments

Attachment 1 – Mifepristone Additional Notes



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Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Policy Team ONLY to complete the following:Date Amended Section Amended Divisional Approval Final Approval 09/11/2017 Complete Revision Penny Maher, A/g DON,

WY&C CHHS Policy Committee

25/06/2018 Addition to section 8 regarding storage of high risk medications

Chair, Medication Management Committee

Chair, Medication Management Committee

27/07/2018 Addition to section 1 to include Triploidy in list of TRC exceptions.

Boon Lim, Clinical Director, WY&C

Boon Lim, Clinical Director, WY&C

27/08/2018 Information pertaining to the where abouts of deceased babies added to section 9

Liz Chatham, ED WY&C Liz Chatham, ED WY&C

This document supersedes the following: Document Number Document NameCHHS16/119 Management of Termination of Pregnancy (TOP), Miscarriage or Fetal DeathCHHS13/172 Fetocide

Attachment 1 – Mifepristone Additional Notes mifepristone is the only anti-progestin that is internationally approved for the induction

of abortion. mifepristone binds to progesterone receptors to reverse their inhibition of cervical softening and dilation, and uterine contraction. More importantly, it sensitizes the myometrium to prostaglandins. The maximum effect of mifepristone is achieved when prostaglandins are administered 36-48 hours after mifepristone dose. mifepristone pre-treatment prior to administration of prostaglandin analogues can be given to prime the uterus. It has been shown to have the following benefits: o increase abortion rate within 24 hours o reduce curettage rate for retained products o reduce induction to abortion interval

There is a 0.2% rate of abortion after mifepristone administration prior to treatment with prostaglandins.

In women given mifepristone pre-treatment, 97% will abort within 5 doses of prostaglandins. Abortion rate and induction-to-abortion interval for 200Mg and 600Mg doses of mifepristone have been found to be the same. Common side effects of the prostaglandins misoprostol and Gemeprost, are:



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o 50% of women will develop a fever o 20-25% suffer from nausea, vomiting, dizziness, diarrhoea or headacheo If a woman has a fever >38.5oC the medical officer should review the woman

regarding possible sepsis, if any signs of infection investigations should be arranged and antibiotics considered. The misoprostol regimen should generally be continued.

The safety and efficacy of mifepristone used in conjunction with a prostaglandin analogue usually misoprostol, is well established, as the best available regimen for medical termination of pregnancy

Prescribers of mifepristone within Australia need to be registered with Marie Stopes International as registered prescribers

misoprostol is licensed for use in pregnancy in Australia for first trimester of termination of pregnancy <49 days gestation, although it has been used extensively both within Australia and worldwide for termination of pregnancy at later gestations and for induction of labour. The woman should be informed of this

Serious infection is an uncommon complication of medical abortion or induction of labour. There have been rare cases of serious infection, including death, after birth in women who have delivered after use of misoprostol and mifepristone from Clostridium sordellii and Clostridium perfringens, and Group A streptococcus. To date, no causal link with mifepristone or misoprostol has been made. All women must be made aware of the risks of infection and be advised to present to hospital immediately if they have symptoms of infection. Potential infection should be investigated and treated appropriately

Administering the misoprostol either vaginally or sublingually results in both a shorter median delivery interval and a reduction in the proportion of women undelivered at 12 and 24 hours after commencement of prostaglandin compared to oral administration. Using the regimen described above with mifepristone and misoprostol <24 weeks gestation, overall, 84 of 302 (27.8%) women were undelivered at 12 hours, comprising 37.0% (95% CI 28.7–47.8) oral, 20.5% (95% CI 14.0–30.1) vaginal, and 21.0% (95% CI 14.3–30.7) sublingual groups. Higher gestation and lower parity increase the time taken to induce delivery. 1.7% of women required a blood transfusion secondary to acute haemorrhage and 5.0% had an estimated blood loss 1,000 mL or greater.



termination of pregnancy (top), miscarriage or … · web viewto provide guidelines for the care...

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