Pregnancy Testing of Children and Young Women of Childbearing potential prior to Cytotoxic Chemotherapy Treatment - Standard Operating Procedure for
|Publication: 25/04/2012 --|
|Last review: 21/02/2018|
|Next review: 21/02/2021|
|Standard Operating Procedure|
|Approved By: Childrens’ Oncology GDG|
|Copyright© Leeds Teaching Hospitals NHS Trust 2018|
This Standard Operating Procedure is intended for use by healthcare professionals within Leeds unless otherwise stated.
Pregnancy Testing of Children and Young Women of Childbearing Potential Prior to Cytotoxic Chemotherapy Treatment
- Summary - Statement of best practice
- Background and indications for standard operating procedure
- Procedure method (step by step)
- Appendix 1
- Appendix 2 - Medical Evidence
- Appendix 3 - Patient Information Sheet
- Every female who has started periods should have a pregnancy test prior to the commencement of the first chemotherapy, as per Pregnancy Test SOP.
- If they are within 10 days of their LMP they should be warned that the test is unreliable and offered retesting at their next visit.
- Consent for testing should be obtained from the patient or parent by the consultant on the chemotherapy consent form.
- Written information as to the reason behind testing and the risk of pregnancy with chemotherapy should be given to the patient and/or the parent as appropriate.
- For each subsequent cycle of chemotherapy, a pregnancy test should occur. This should be included in pre-chemotherapy assessment and recorded appropriately. For ALL maintenance treatment, 3 monthly testing is recommended.
- If a patient or parent declines pregnancy testing, refer to their consultant for discussion and advice.
- Pregnancy testing needs to be undertaken in a consistent and sensitive manner.
Confidentiality should be maintained unless the health professional believes that there is a risk to the health, safety or welfare of a young person or others. Parental consent is not necessary if the patient is competent to consent.
There is evidence which indicates that chemotherapy treatment carries the risk of spontaneous abortion and foetal damage to an unborn child (Drugs & Therapeutics, 1996). In order to reduce the risks to any unborn child, and the obstetric risk to the mother, the possibility of pregnancy should be considered and assessed in all females of child bearing age, prior to the commencement of chemotherapy.
Research has shown that more than a quarter of young people are sexually active before they reach 16. The age at which the majority of 16-19 year olds first have sexual intercourse is 16; almost 30% of young men and almost 26% of young women report having intercourse before their 16th birthday. By the age of 20 the vast majority of young people today have had sexual intercourse (Wellings at al, 2001).
Young people under 16 are the group least likely to use contraception and concern about confidentiality remains the biggest deterrent to seeking advice (Department of Health, 2004). Ensuring that pregnancy has been considered prior to administration of cytoxic therapy should be an integral part of pre chemotherapy assessment of all female patients of childbearing potential. In practice, this should include all females who have started menstruating, regardless of age. Routine pregnancy testing, in conjunction with sexual health information and education, should be offered prior to the commencement of first chemotherapy, regardless of disclosure of sexual activity.
Pregnancy testing needs to be undertaken in a consistent, sensitive and confidential manner. Guidance from the Department of Health clearly states that the duty of confidentiality owed to a person under 16, in any setting, is the same as that owed to any other person (Department of Health, 2004).
Safer surgery NPSA guidance (RRR011 Issue date: 28 April 10), states that organisations need to ensure there are pre op policies in place that address pregnancy testing for ‘all relevant female patients’.
There are a number of areas within the trust that follow a policy of pregnancy status questioning for all female patients aged 12-55 inclusive. This includes radiology and radiotherapy where checking of pregnancy status is routine practice.
Consent and confidentiality
Adults, defined as people over the age of 18, are usually regarded as competent to decide their own treatment (Department of Health, 2004). The Family Law Reform Act 1969 also gives the right to consent to treatment to anyone aged 16 &17.
Young people under the age of 16 can consent to medical treatment if they have sufficient maturity and judgement to enable them fully to understand what is proposed. This was clarified in England and Wales by the House of Lords in the case of Gillick versus West Norfolk and Wisbech AHA & DHSS in 1985. The vast majority of our patients in this age group attend the clinic with their parents and will have no confidences from their parents about their disease. However like other young people some of them will have areas of their lives that they do not share with their parents.It is important that we create an opportunity for them to be counselled on their own.
Although it is an offence to have sex with someone under the age of 16 it is lawful for doctors to provide contraceptive advice and treatment without parental consent providing certain criteria are met. These criteria, known as the Fraser Guidelines, were laid down by Lord Fraser in the House of Lords' case and require the professional to be satisfied that:
- the young person will understand the professional's advice;
- the young person cannot be persuaded to inform their parents;
- the young person is likely to begin, or to continue having, sexual intercourse with or without contraceptive treatment;
- unless the young person receives contraceptive treatment, their physical or mental health, or both, are likely to suffer;
- the young person's best interests require them to receive contraceptive advice or treatment with or without parental consent.
Although these criteria specifically refer to contraception, the principles are deemed to apply to other treatments.
The duty of confidentiality is not, however, absolute. Where a health professional believes that there is a risk to the health, safety or welfare of a young person or others which is so serious as to outweigh the young person’s right to privacy, they should follow locally agreed child protection protocols, as outlined in Working Together to Safeguard Children (2006). In these circumstances, the over-riding objective must be to safeguard the young person. If considering any disclosure of information to other agencies, including the police, staff should weigh up against the young person’s right to privacy the degree of current or likely harm, what any such disclosure is intended to achieve and what the potential benefits are to the young person’s well-being.
All staff members should ensure that they have completed mandatory Child Protection training.
Young people between 13 and 16
Sexual activity with a child under 16 is an offence. Where it is consensual it may be less serious than if the child were under 13, but may have serious consequences for the welfare of the young person (Bishop & Soanes, 2010). Any concerns should be discussed with a named nurse or doctor for child protection.
Young people under the age of 13
Any child under the age of 13 years who is thought to be sexually active should always be discussed with a named nurse or doctor for child protection. Under these circumstances it is thought reasonable to suspect that a child is suffering or is likely to suffer significant harm. The case will be reported to Social Services, and a strategy discussion will be held in accordance with local Child Protection Procedures. This should involve social care, police, and relevant agencies, to discuss appropriate next steps with the professional.
NB - Be sensitive of patients who may have undergone gynaecological surgery. Check if hysterectomy or oophrectomy have occurred and do not question pregnancy status if the patient has undergone such a sterilising procedure. However if patients have undergone tubal ligation it is sensible to point out that this fallible and offered testing.
- The test is performed on a urine sample.
- Ask patient to provide urine specimen and place in white-topped universal container.
- Send on Clinical Biochemistry & Haematology form requesting ‘HCG’. Clinical details must be given.
- Look up results on results server.
- Document in patient notes and on chemotherapy chart if patient having chemotherapy
- Test with SureStrip One Step hCG Pregnancy Test.
- Read the result at 3-4 minutes. Reading too soon or too late can give false negative or false positive results.
- If the test is positive two distinct coloured lines should appear - one in the control line region and one in the test line region. The result is invalid if the control line fails to appear.
- Document the results in the medical notes and on chemotherapy chart
- If the result is negative providing all other ‘critical tests’ are complete, investigations and/or treatment may proceed.
If the result is positive, refer to Consultant for further advice.
When to test.
Pregnancy testing must be carried out before each chemotherapy cycle
Patients with a Germ Cell Tumour may produce a positive test due to their disease. Refer to patient’s Consultant for advice for these patients.
To standardise and optimise the testing for pregnancy of children and young women of childbearing potential prior to cytotoxic chemotherapy treatment
|Target patient group:||Females of childbearing potential who are receiving chemotherapy|
|Target professional group(s):||Secondary Care Doctors
Secondary Care Nurses
- Bishop, L and Soanes L (2010) Pregnancy testing prior to cancer therapy. The Royal Marsden NHS Foundation Trust. London
- Brook Advisory (2006) Under 16s – the Law and Public Policy on Sex, Contraception and Abortion in the UK Brook Advisory
- Department of Health (2006) Teenage Pregnancy: Working Towards 2010. Good practice and Self-assessment Toolkit, London: Department for Education and Skills
- Department of Health (2004) Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health , London: DH
- Drugs & Therapeutics Bulletin. (1996) Pre-Conception, Pregnancy and Prescribing. DTB Vol 34. 4. 25-27
- Gillick v West Norfolk and Wisbech Area Health Authority  AC 112 1ALL ER
- Wellings, K., Nanchahal, K., Macdowall, W., McManus, S., Erens, R., et al. (2001) Sexual Behaviour in Britain: early heterosexual experience. Lancet 358: 1843-50
Childrens’ Oncology GDG
LHP version 1.0
Legal advice regarding pregnancy testing of girls of child bearing age
For the purpose of this document it was necessary to seek legal advice. Mr Bertie Leigh, Senior Partner at Hempsons Solicitors who currently act for NHS Trusts and other health organisations informed us that:
“If prescribing and administering teratogenic therapy to women in their reproductive epoch, you have a duty to advise them of this fact. In practice this means asking them whether they may be pregnant and if there may be any uncertainty on the point active you should offer to test them.
People under the age of 16 are able to give consent if they understand the nature, purpose and implications of the investigation. If the test proves positive you should try to persuade the patient to let you tell her parents and to involve them in the management of this problem. But if she refuses her wishes should be respected unless you are satisfied that the risk to her health, safety or welfare is such that it is necessary to violate her confidence. In such circumstances you should follow local child protection protocols. Where children under 13 appear to be sexually active it is always advisable to involve the Child Protection Team.”
(Cited by Sr Sue Lill)
- A teratogen is a substance that causes structural or functional abnormality in a foetus exposed to a substance.
- Drugs taken during embryonic phase (weeks 3-8 post-conception) have the greatest potential to cause gross malformations by affecting organ genesis.
- Medicines taken at, or around conception or during pregnancy can harm the foetus. Before prescribing a drug to a woman of childbearing age, the prescriber should check whether the drug could cause foetal damage. If it is necessary to use a drug thought to be unsafe in the first trimester, it is important to determine whether the women is pregnant. Potential risks of taking or withholding the drug should be presented clearly so that the women can decide what to do. Drugs & Therapeutics (1996)
- Drug therapy for cancer and investigations such as X-rays, CT Scans, and MRI Scans can harm a developing foetus, particularly in the first 3 months of pregnancy.
- Most cancer treatment protocols and drug company’s guidelines recommend that the risk of pregnancy in females of childbearing age should be excluded before commencing treatment.
- Drugs & Therapeutics Bulletin. (1996) Pre-Conception, Pregnancy and Prescribing. DTB Vol 34. 4. 25-27
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