Issued:10th May 2002
PRESS RELEASE
NICE issues guidance for rhesus negative women during pregnancy.
The National Institute for Clinical Excellence has issued guidance to the NHS in England and Wales on the use of a treatment called Routine Antenatal Anti-D Prophylaxis that can prevent the babies of rhesus negative women being stillborn.Women who are rhesus negative are missing a substance called D antigen on their red blood cells. Most of the time this is not an issue, however if they are pregnant and their baby is rhesus positive (has the D antigen on their blood cells) it may cause problems.
If blood cells from a rhesus-positive baby get into the mother's bloodstream and she is rhesus negative, her blood will react as if it is a foreign substance and will produce antibodies. This is not usually dangerous in a first pregnancy, but in later pregnancies if the baby she is carrying is also rhesus positive these antibodies can cross the placenta and attack the blood cells of the unborn baby. This can cause 'haemolytic disease of the newborn'. This disease can be very mild and only detectable by laboratory tests - but in a small number of babies it can be more serious and cause the baby to be stillborn, severely disabled or to die after birth as a result of anaemia and jaundice.
Anti-D prophylaxis is a preventative treatment that can be given to rhesus negative mothers. A substance called anti-D immunoglobulin is injected into the mother to prevent her producing antibodies to her baby's blood. This in turn prevents the development of 'haemolytic disease in the unborn baby.
NICE has recommended that pregnant rhesus negative women should be offered this preventative treatment routinely, unless they already have antibodies to the D antigen in their blood. The antibodies can be detected by a blood test at the beginning of pregnancy.
NICE has also recommended that health care professionals (midwives, obstetricians or GPs) should explain the options available to rhesus negative mothers, so they can make an informed choice about treatment.
Andrea Sutcliffe, Planning and Resources Director and executive lead for this appraisal, said, "In England and Wales haemolytic disease of the newborn is responsible for the deaths of between 25 and 30 babies every year, and causes around 45 more to suffer developmental problems".
"The independent committee that advises us considered the evidence for this routine antenatal anti-D treatment very carefully and consulted widely with health professionals and the groups that represent pregnant women. In summary the Committee advised us that this treatment should be routinely offered to pregnant women, but that there are circumstances in it may not be clinically necessary or cost effective. For example when the woman has opted to be sterilised after birth, where the father is rhesus negative, or where the woman is most unlikely to have another child"
NICE was asked to produce guidance on this treatment because there was genuine uncertainty regarding its clinical and cost effectiveness. Currently about one third of NHS hospitals in England and Wales offer this treatment to rhesus negative mothers, the NICE guidance today makes it clear to the NHS across England and Wales, that rhesus negative women should be routinely offered this preventative treatment unless they already have antibodies to the D antigen in their blood. In making the decision whether to use this treatment we are clear that women should be fully informed of all the issues.
Ends
Notes for editors
THIS IS SUMMARY INFORMATION THE FULL GUIDANCE SHOULD BE CONSULTED
RhD-negative,
1. The rhesus factor is found in the red blood cells. People who are rhesus positive have a substance known as D antigen on the surface of their red blood cells - they are said to be RhD positive. People who are rhesus negative do not have the D antigen on their blood cells - they are RhD negative. Whether a person is RhD positive or RhD negative is determined by their genes.
Heamolytic disease of the new born
2. If the blood cells from an RhD-positive baby get into the blood of an RhD-negative woman, she will react to the D antigen in the baby's blood as though it is a foreign substance and will produce antibodies. This is not usually dangerous in a first pregnancy, but in later pregnancies the antibodies in the mother's blood can cross the placenta and attack the blood cells of an RhD-positive unborn baby. This can cause 'haemolytic disease of the newborn', (HDN). HDN can be very mild and only detectable by laboratory tests. But it can be more serious and cause the baby to be stillborn, severely disabled or to die after birth as a result of anaemia (lack of iron in the blood) and jaundice.
3. Each year in England and Wales:
4. The most common time for a baby's blood cells to get into the mother's blood is at the time of birth. However it can occur at other times, for example during a miscarriage or abortion, or as the result of having an amniocentesis, chorionic villus sampling, vaginal bleeding or external cephalic version (turning the baby head down). An event that could cause the mother to produce antibodies against the D antigen is called a 'potentially sensitising event'.
Anti-D prophylaxis
5. Anti-D prophylaxis is anti-D immunoglobulin given to prevent a woman producing antibodies against RhD-positive blood cells and so to prevent the development of HDN in an unborn baby. Anti-D immunoglobulin is made from plasma that is collected from blood donors. The production of anti-D immunoglobulin is very strictly controlled to ensure that the chance of a known virus being passed from the donor to the person receiving the anti-D immunoglobulin is very low - it has been estimated to be 1 in 10,000 billion doses.
6. Routine antenatal anti-D prophylaxis (RAADP) is given by injection to pregnant women who are RhD-negative usually at weeks 28 and 34 of their pregnancy. After the birth, a blood sample will be taken to test the baby's blood group. If the baby is RhD positive, a mother who is RhD negative will be given a further injection of anti-D immunoglobulin (postnatal anti-D prophylaxis - not the subject of this NICE guidance). If an RhD-negative woman has a potentially sensitising event during the pregnancy (that is she is in apposition where her blood may ba in contact with cells from her unborn baby) she will be offered anti-D prophylaxis at the time of the event (known as antenatal anti-D prophylaxis or AADP).
NICE guidance
7. It is recommended that routine antenatal anti-D prophylaxis (RAADP) is offered to all non-sensitised pregnant women who are RhD negative.
8. The clinician (obstetrician, midwife or general practitioner) responsible for the l care of a non-sensitised RhD-negative pregnant woman should discuss with her RAADP and the options available so that the woman can make an informed choice about treatment. This discussion should include the circumstances where RAADP would be neither necessary nor cost effective. Such circumstances might include those where the woman:
The difference between RAADP (i.e. routine prophylaxis at 28 and 34 weeks) and prophylactic anti-D given because of likely sensitisation should be clearly explained to the woman.
9. A woman's use of RAADP at 28 and 34 weeks should not be affected by whether she has already had antenatal anti-D prophylaxis (AADP) for a potentially sensitising event early in pregnancy. A woman's use of postpartum anti-D prophylaxis should similarly not be affected by whether she has had RAADP or AADP as the result of a sensitising event. Beyond this, AADP for a potentially sensitising event and postpartum anti-D prophylaxis are not the remit of this guidance. These matters are covered by the Royal College of Obstetricians and Gynaecologists' 'Green Top' 1999 guideline: Use of Anti-D Immunoglobulin for Rh Prophylaxis.
10. It is recommended that high-quality information, validated and produced at the national level, is made available to RhD-negative women and the relevant healthcare professionals.
11. If routine anti D were to be given throughout England and Wales to all RhD- negative women at each pregnancy, the drug and administrative costs would be about £6 million per year. Given that about 30% of hospitals already treat RhD- negative women routinely, and that negotiated prices for anti-D may be lower than list prices, it is unlikely that drug and administrative costs would increase by more than £4 million as a result of the guidance.
Consultees
Information on NICE
9. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from midday on 10 May 2002.
10. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
11. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
12. It is the Medicines Control Agency that determines whether a drug is safe and subsequently licence it for sale in the UK. NICE issues guidance on good clinical practice for the NHS to ensure access to effective care for people in England and Wales. NICE recommendations are considered and objective and take account of the licence granted by the MCA, the patient's perspective as well the views of professionals who care for them.
13. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. The Institute supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
14. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, audit tools are produced for use in the clinical setting.
