MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINE

Site ApplicabilityThis policy is for use in the Women’s Health Centre at BC Women’s Hospital

Practice Level/Competencies

Nursing:

Basic & Advanced Skill – The nurse is required to have in-depth knowledge of first trimester miscarriage, pharmacological and physiological action of Mifepristone/Misoprostol (mife/miso). Suitable education of first trimester is completed through Perinatal Specialty certificate. Pharmacological education is obtained onsite through Mifepristone teaching session and mentoring.

Physician:

Basic & Specialized skill – the physician is required to have advanced education in early pregnancy management, and/or ultrasonography.

Policy Statement(s)

Persons with first trimester miscarriage will be offered expectant, medical or surgical management.

Persons selecting medical management will be counselled on the risk of success using mife/miso and need for aspiration.The purpose of this policy on the Medical Management of First Trimester Miscarriage is to

a) Establish a guiding definition of first trimester pregnancy loss.b) Set out a care pathway for providers responsible for the medical management of first trimester

lossThis policy applies to persons who are appropriate candidates for medical management of first trimester miscarriage. In this document, first trimester miscarriage will refer to any intrauterine demise up to 12w6d based on ultrasound.This policy applies to all staff providing care to persons at the Women’s Health Centre.

Equipment & SuppliesUltrasound Prescription

Relevant patient teaching materials

Steps & RationaleSTEPS RATIONALEDiagnosis:

Diagnosis of first trimester miscarriage is determined by physician through endo-vaginal ultrasoundThe gold standard for diagnosis of first trimester pregnancy miscarriage includes

a) Mean sac diameter (MSD) >=25mm with NO yolk sac seenOR

b) CRL >=7mm with NO cardiac activity

Ultrasound is required to determine:a) gestational age at fetal demiseb) presence of yolk sacc) PUV

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MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINEOR

c) Pregnancy of unknown viability (PUV) with no appropriate interval change

Evaluation:

All persons meeting the criteria for first trimester miscarriage are evaluated by history, physical, and/or ultrasound.

All aspects of patient condition will be evaluated to determined best methods for patient care.

Management:

Following the above evaluation, persons with first trimester miscarriage can be offered expectant, medical or surgical management.

Persons selecting medical management are counselled on the risk of success using mife/miso and need for aspiration.Patients with contraindications to mifepristone will be offered medical management with misoprostol only.

Patient choice, when medically appropriate, will be considered to provide patient centered care

Patients must be fully informed of the risks and benefits of their chosen treatment

Regimen:Day #0 is mifepristone and Day #1 is misoprostol:

Regimens Success Rate at Day #2-3

Success Rate at Day #8

Success rate at Day #30

Aspiration

Mife/miso (up to 12wk)1

Mife 200 mg POMiso 800 mcg PV

84% 89% 91% 9%

Miso only1

Miso 800 mcg PV x 2 doses prn

67% 75% 76% 24%

D&C2 97% 97%Contraindications:

The following patients should not be offered medical management

Contraindications to mifepristone : Allergy/Hypersensitivity to mifepristone Ectopic pregnancy Severe anemia Hb (< 95 g/L) Coagulation disorder or using concurrent

anticoagulation therapy (not prophylaxis) Uncontrolled asthma Porphyria Chronic adrenal failure

1 Schreiber C, Creinin M, Atrio J, Sonalkar S, Ratcliffe S, Barnhart B, Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. N Engl J Med 2018; 378:2161-21702 Nanda K, Lopez LM, Grimes DA, Peloggia A, Nanda G. Expectant care versus surgical treatment for miscarriage. Cochrane Database of Systematic Reviews 2012, Issue 3.C-06-07-60692 Published Date: 26-Jun-2020Page 2 of 7 Review Date: 09-Jun-2023

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MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINE Concurrent long-term systemic corticosteroid

therapy

Contraindications to misoprostol: Allergy/Hypersensitivity to misoprostol Ectopic pregnancy Severe anemia Hb (< 95 g/L) Coagulation disorder or using concurrent

anticoagulation therapy (not prophylaxis)

Management

Patients selecting medical management with mifepristone are given the following:

Prescription for Mifegymiso (Mifepristone 200mg/Misoprostol 800mg)

Prescription for acetaminophen/codeine (EMTEC 30) – 6 tablets

Information Sheet/Symptom Diary

The information sheet/symptom diary is used as both a reference for the patient as well as a record of experience for the follow-up

Follow-up

All patients selecting mife/miso or miso only will be called on Day #8. Time, route, onset and duration of pain and bleeding will be clearly documented in the patient’s chart.

If the patient does not report symptoms suggestive of miscarriage, she should be given an appointment to return to EPAC in the next 48 hours

If the patient does report symptoms suggestive of miscarriage, she should be advised to do a urine pregnancy test 1 month after taking mife/miso (Day #30)

This is suggestive of treatment failure and the patient is required to have an assessment to determine need for aspiration

Special Circumstances1. Persons wishing to become pregnant again. How

long should they wait after mife/miso?They can begin trying to conceive with the next cycle. The half-life of mifepristone and misoprostol is short and is usually excreted from the body 3-4 days after ingestion.

2. Persons using progesterone for luteal support. When should they discontinue and resume?

Once a demise has been confirmed, they should stop progesterone. They may resume with the next cycle in which they are trying to conceive.

3. Persons using baby ASA. Should they discontinue?

No, it is not necessary for them to discontinue. However, if the indication is pregnancy, they can discontinue and resume once they have a positive pregnancy test.

4. Persons using prophylactic dosing of low molecular weight heparin (e.g. enoxaparin [Lovenox], dalteparin [Fragmin]). Should they discontinue?

Yes, they should be advised to discontinue and take mifepristone 24 hours after last dose. If the indication is pregnancy, they may resume once they have a positive pregnancy test or when advised by their physician. If the indication is not pregnancy, they may resume 24 hours after the onset of the miscarriage (assuming that heavy bleeding has decreased by that point). These patients may benefit from a call phone call on Day #2 to ensure heavy

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MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINEbleeding has decreased sufficiently for them to restart prophylactic enoxaparin or dalteparin.

5. Can persons continue breastfeeding while taking mife/miso?

Yes. Mife is excreted in breastmilk but not at detectable levels. Miso is also excreted. No adverse events have ever been detected in exposed infants to either of these meds.

6. Should persons take misoprostol if they report bleeding within 24 hours from mifepristone?

Yes, bleeding commonly occurs. Persons should still complete the treatment with misoprostol.

7. What should persons do if they experience nausea and vomit < 1 hour from taking mifepristone?

If < 1 hour, persons should be advised to take another dose of mifepristone. They should be offered an anti-emetic.

Documentation Interdisciplinary progress notes Patient Assessment sheet

Patient & Family Engagement/EducationPatients must be thoroughly counselled on the regime of taking mife/miso, side effects, what to expect from the medication, where/how to get the medication, and when to follow-up and/or seek further medical treatment.

Patients are given information sheet(s) regarding medical management with mife/miso which is accompanied by a treatment/symptom diary.

ReferencesACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol 2018; 132 (5):e197–e207.

Nanda K, Lopez LM, Grimes DA, Peloggia A, Nanda G. Expectant care versus surgical treatment for miscarriage. Cochrane Database of Systematic Reviews 2012, Issue 3.

RCOG, Clinical Guidelines for Early Medical Abortion at Home – England, Published 3/1/2019.

Schreiber C, Creinin M, Atrio J, Sonalkar S, Ratcliffe S, Barnhart B, Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. N Engl J Med 2018; 378:2161-2170

DefinitionsExpectant management: allowing for spontaneous passage of retained products of conception, usually within 2-6wksFirst trimester miscarriage: any intrauterine demise up 12w6d based on ultrasound

Medical Management: oral medicines given for treatment which accelerate expulsion of tissues from pregnancy loss

Mifegymiso: a brand name for the combination package of medications mifepristone & misoprostol (mife/miso)

Surgical Management: dilation of the cervix followed by removal of the pregnancy tissues with sharp curettage, suction curettage, or both. The procedure is typically performed under intravenous conscious sedation and a paracervical block.

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MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINEAppendix

Appendix A: Patient Information Sheet

Appendix B: Treatment/Symptom Diary

Version HistoryDATE DOCUMENT NUMBER and TITLE ACTION TAKEN09-June-2020 C-06-07-60692 Medical Management of First Trimester

MiscarriageApproved at: Pharmacy, Therapeutics & Nutrition Committee Meeting

DisclaimerThis document is intended for use within BC Children’s and BC Women’s Hospitals only. Any other use or reliance is at your sole risk. The content does not constitute and is not in substitution of professional medical advice. Provincial Health Services Authority (PHSA) assumes no liability arising from use or reliance on this document.  This document is protected by copyright and may only be reprinted in whole or in part with the prior written approval of PHSA. 

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MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINEAppendix A: Patient Information Sheet

C-06-07-60692 Published Date: 26-Jun-2020Page 6 of 7 Review Date: 09-Jun-2023

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MEDICAL MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE

DOCUMENT TYPE: GUIDELINE

Appendix B: Treatment/Symptom Diary

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This is a controlled document for BCCH& BCW internal use only – see Disclaimer at the end of the document. Refer to online version as the print copy may not be current.