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Royal College of Obstetriciansand Gynaecologists

Consent Advice No. 10June 2010

SURGICAL EVACUATION OF THE UTERUS FOR EARLYPREGNANCY LOSS

This is the first edition of this guidance. This paper provides advice for clinicians in obtaining consentof women undergoing surgical evacuation of the uterus for early pregnancy loss.

This paper is intended to be appropriate for a number of procedures and combinations and the consentform should be carefully edited under the heading ‘Name of proposed procedure or course oftreatment’ to accurately describe the exact procedure to be performed, after discussion with thewoman. The paper follows the structure of Consent Form 1 of the Department of Health, England/WelshAssembly Government/Scottish Government/Department of Health, Social Services and Public Safety,Northern Ireland. It should be used in conjunction with RCOG Clinical Governance Advice No. 6Obtaining Valid Consent.1 Please also refer to RCOG Green-top Guideline No. 25: The Managementof Early Pregnancy Loss.2

The aim of this advice is to ensure that all women are given consistent and adequate information forconsent; it is intended to be used together with dedicated patient information. After discharge womenshould have clear direction to obtaining help if there are unforeseen problems.

Clinicians should be prepared to discuss with the women any of the points listed on the following pages.

The above descriptors are based on the RCOG Clinical Governance Advice, Presenting Information on Risk.2 They

are used throughout this document.

To assist clinicians at a local level, we have included at the end of this document a fully printable page2 of the Department of Health, England/Welsh Assembly Government/Scottish Government/Depart-ment of Health, Social Services and Public Safety, Northern Ireland, Consent Form 1. This page can beincorporated into local trust documents, subject to local trust governance approval.

Presenting information on risk

Term Equivalent numerical ratio Colloquial equivalent

Very common 1/1 to 1/100 A person in family

Common 1/10 to 1/100 A person in street

Uncommon 1/100 to 1/1000 A person in village

Rare 1/1000 to 1/10 000 A person in small town

Very rare Less than 1/10 000 A person in large town

Consent Advice 10 © RCOG 2010

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CONSENT FORM

1. Name of proposed procedure or course of treatmentSurgical evacuation of the uterus for early pregnancy loss.

2. The proposed procedureDescribe the nature of the procedure: removal of early pregnancy tissue from the uterus, usually with suctioncurettage. Explain the procedure as described in the RCOG or locally produced information leaflets/tapes. Note:if other procedures are anticipated, such as diagnostic laparoscopy to exclude ectopic pregnancy if there is nopregnancy tissue in the uterus, then these must be discussed and a separate consent obtained.

3. Intended benefitsThe aim of the procedure is to treat an incomplete or missed miscarriage, or retained placental tissue, when thewoman prefers surgical as opposed to medical or expectant treatment, or if there is a medical indication forsurgery such as sepsis, heavy bleeding or haemodynamic instability, or where other treatments have failed, orthere is a suspicion of gestational trophoblastic disease.

4. Serious and frequently occurring risks2,4–7

It is recommended that clinicians make every effort to separate serious from frequently occurring risks.

Women who are obese, who have significant pathology, have had previous surgery or who have pre-existingmedical conditions must understand that the quoted risks for serious or frequent complications will beincreased.

4.1 Serious risksSerious risks include:● uterine perforation, up to five in 1000 women (uncommon)

● significant trauma to the cervix (rare)

● there is no substantiated evidence in the literature of any impact on future fertility.

4.2 Frequent risksFrequent risks include:● bleeding that lasts for up to 2 weeks is very common but blood transfusion is uncommon (1–2 in 1000 women)

● need for repeat surgical evacuation, up to five in 100 women (common)

● localised pelvic infection, three in 100 women (common).

5. Any extra procedures which may become necessary during the procedure● Laparoscopy or laparotomy to diagnose and/or repair organ injury or uterine perforation.

6. What the procedure is likely to involve, the benefits and risks of any available alternativetreatments, including no treatment 2,4–7

The cervix may need to be dilated to allow emptying of the uterine contents. If tissue is sent for histology, thereasons (to exclude ectopic or molar pregnancy) should be explained.

The alternatives are:❍ medical management (with mifepristone, prostaglandins)❍ expectant management, particularly for women without an intact sac.

Non-surgical methods are associated with longer and/or heavier bleeding and a 15–50% possibility of eventuallyneeding surgical evacuation for clinical need or the woman’s preference. However, non-surgical methods arealso associated with a lower risk of infection compared with surgery.

Consent Advice 102 of 4

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7. Statement of patient: procedures which should not be carried out without furtherdiscussion

Other procedures, which may be appropriate but not essential at the time, should be discussed and the woman’swishes recorded.

8. Preoperative InformationA record should be made of any sources of information (such as RCOG or locally produced informationleaflets/tapes) given to the woman prior to surgery. Please refer to the RCOG Patient Information: EarlyMiscarriage: Information for You.4.

9. AnaesthesiaGeneral or local anaesthesia can be used. Where possible, the woman must be aware of the form of anaesthesiaplanned and be given an opportunity to discuss this in detail with the anaesthetist before surgery. It should benoted that, with obesity, there are increased risks, both surgical and anaesthetic.

References

1. Royal College of Obstetricians and Gynaecologists. Obtaining Valid Consent. Clinical Governance Advice No. 6. London: RCOG; 2008[www.rcog.org.uk/womens-health/clinical-guidance/obtaining-valid-consent].

2. Royal College of Obstetricians and Gynaecologists. The Management of Early Pregnancy Loss. Green-top Guideline No. 25. London:RCOG; 2006 [/www.rcog.org.uk/womens-health/clinical-guidance/management-early-pregnancy-loss-green-top-25].

3. Royal College of Obstetricians and Gynaecologists. Presenting Information on Risk. Clinical Governance Advice No. 7. London: RCOG;2008 [www.rcog.org.uk/womens-health/clinical-guidance/presenting-information-risk].

4. Royal College of Obstetricians and Gynaecologists. Early Miscarriage: Information for You. London: RCOG; 2008[www.rcog.org.uk/womens-health/clinical-guidance/early-miscarriage-information-you].

5. Nanda K, Peloggia A, Grimes DA, Lopez LM, Nanda G. Expectant care versus surgical treatment for miscarriage. Cochrane Database SystRev 2006;(2):CD003518. DOI: 10.1002/14651858.CD003518.pub2.

6. Forna F, Gülmezoglu AM. Surgical procedures to evacuate incomplete miscarriage. Cochrane Database Syst Rev 2001;(1)CD001993. DOI:10.1002/14651858.CD001993.

7. Trinder J, Brocklehurst P, Porter R, M Read, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results ofrandomised controlled trial (miscarriage treatment (MIST) trial). BMJ 2006;332:1235–40. DOI: 10.1136/bmj.38828.593125.55.

The Consent Advice review process will commence in2013 unless otherwise indicated

This Consent Advice was produced by Mr D Siassakos MRCOG, Bristol, with the support of the Consent Group of the Royal College ofObstetricians and Gynaecologists.

It was peer reviewed by:Dr ECO Edi-Osagie MRCOG, Manchester; Mr RG Farquharson FRCOG, Liverpool; Mr HKS Hinshaw FRCOG, Sunderland; Dr G KumarMRCOG, Wrexham; RCOG Consumers’ Forum ; Dr J Trinder FRCOG, Bristol

The final version is the responsibility of the Consent Group of the RCOG.

3 of 4Consent Advice 10 © RCOG 2010

DISCLAIMER

The Royal College of Obstetricians and Gynaecologists produces consent advice as an aid to good clinical practice. Theultimate implementation of a particular clinical procedure or treatment plan must be made by the doctor or otherattendant after the valid consent of the woman in the light of clinical data and the diagnostic and treatment optionsavailable. The responsibility for clinical management rests with the practitioner and their employing authority and shouldsatisfy local clinical governance probity.

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Patient identifier/label

Name of proposed procedure or course of treatment(include brief explanation if medical term not clear) Surgical evacuation of the uterus (womb): operation toremove pregnancy tissue from within the womb when a miscarriage has not completed.

Statement of health professional (to be filled in by health professional withappropriate knowledge of proposed procedure, as specified in consent policy)I have explained the procedure to the patient, in particular, I have explained: The cervix (neck of thewomb) may need to be dilated (opened) and the pregnancy tissue removed. If it is expected that it may be difficultto open the cervix, tablets or pessaries may be given first to make the cervix softer and the operation safer.

The intended benefits: To remove any pregnancy tissue from within the womb.

Serious risks:● Significant tear of the neck of the womb (rare).● Perforation of the womb, up to 5 in 1000 women (uncommon).

Frequent risks:● Bleeding that lasts for up to 2 weeks is very common but heavy bleeding is uncommon

(1–2 in 1000 women).● Need for repeat procedure if all the pregnancy tissue is not removed, up to 5 in 100 women

(common).● Pelvic infection, 3 in 100 women (common).

Any extra procedures which may become necessary during the procedure

laparoscopy (keyhole surgery) to investigate for any suspected injury, if there is perforation ofthe womb

laparotomy (open surgery) to repair any injury

other procedure (please specify)

I have also discussed what the procedure is likely to involve, the benefits and risks of any availablealternative treatments (including no treatment) and any particular concerns of this patient.

The following leaflet/tape has been provided: Please see RCOG Patient Information: Early Miscarriage:Information for You

This procedure will involve:

general and/or regional anaesthesia local anaesthesia sedation

Signed .................................................................................................. Date ............................................................................

Name (PRINT)........................................................................................ Job title......................................................................

Contact details (if patient wishes to discuss options later)

Statement of interpreter (where appropriate)I have interpreted the information above to the patient to the best of my ability and in a way in which Ibelieve s/he can understand

Signed .................................................................................................. Date ............................................................................

Name (PRINT) ....................................................................................................................................................................................

Top copy accepted by patient: yes/no (please ring)