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Guidelines for the Management of Diabetes in Pregnancy Royal United Hospital January 2006 TYPE 1 DIABETES Background Approximately 2-4/1000 women who become pregnant have previously diagnosed type 1 diabetes. In women with diabetes there are greater risks both to the mother and the fetus. Fetus Despite advances in diabetes care, babies born to women with type 1diabetes are almost 5 times as likely to be stillborn and nearly 3 times as likely to die in the first month of life as those in women without diabetes. The babies are also twice as likely to have a major congenital malformation (Confidential enquiry into maternal and child health, Oct 2005). Cardiac and neural tube defects occur approximately 3 times more often than the background population. Many have multiple congenital abnormalities. The most common problem seen in the infant is macrosomia which can result in birth trauma. Fetal hyperinsulinaemia that results from maternal hyperglycaemia causes neonatal hypoglycaemia and also accelerates skeletal maturation and delays pulmonary maturation. Infants also have an increased risk of jaundice and are at higher risk of polycythaemia. Maternal Early in pregnancy, women with diabetes have an increased risk of miscarriage. Pregnant women with diabetes are likely to notice a change in their insulin requirements. Particularly in the early stages there may be increased risk of hypoglycaemia, with the risk of hypoglycaemia unawareness. Later in the pregnancy as insulin requirements increase, there may be an increased risk of diabetic ketoacidosis. Diabetic retinopathy can worsen during pregnancy especially if there is a rapid change in glycaemic control, and may require laser treatment. Women with diabetes have a higher risk of infections than women without diabetes and 2-3 times the risk of pre-eclampsia. Polyhydramnios is also more likely with an increased risk of premature labour and postpartum haemorrhage. Women with diabetes and vascular disease are also at risk of intrauterine growth retardation. During the birth they are at increased risk of obstructed labour, especially shoulder dystocia and a greater intervention rate. 1 Pre-Pregnancy Management Diabetic women of child bearing age will be seen in the general diabetes outpatient clinic. Information and counselling should be provided to all these women so that they are aware of the problems of diabetes in pregnancy, potential dangers of an unplanned pregnancy and the benefits of pre-pregnancy counselling. Diabetic women should be advised not to contemplate pregnancy until their glycaemic control has been optimised (HbA1c <7%) and guidance should be provided from the diabetic team in order to achieve this. They should also be advised to stop smoking if they smoke. Diabetic women planning pregnancy should be prescribed 5mg folic acid. During pre-pregnancy planning, the need for any potential teratogenic drugs (e.g. anti-hypertensives,) should be reviewed and swapped to drugs that are safe during pregnancy (if necessary). Statins should be stopped Assessment of diabetes complications o Retinopathy – retinopathy that requires laser treatment should be treated before pregnancy as pre-existing retinopathy may progress more rapidly during pregnancy. o Nephropathy – screen using albumin/creatinine ratio. If > 3.4mg/mmol on screening an overnight sample should be collected. o Macrovascular disease – pre-existing heart disease requires cardiological review before conception. o Autonomic neuropathy may severely complicate the management of diabetes in pregnancy, and women should be aware of the risks involved. Thyroid function should be checked as abnormalities in women with type 1 diabetes are common and may adversely affect pregnancy outcomes. 2 Ante-Natal Management Women should be booked into the joint diabetes/ante-natal clinic as soon as they find out they are pregnant. Ensure patients are taking folic acid at 5mg dose and any teratogenic medications have been stopped if pregnancy was not planned. During the first visit, the woman should be given the relevant telephone numbers of the diabetes specialist nurses working in her area and the hospital diabetes specialist nurses, so they have someone to call for advice. Glycaemic control will be checked at the booking visit (HbA1c and fructosamine). Other routine investigations such as urea and electrolyes, random lipids and urine microalbumin will be carried out , if no recent record. If possible dilated fundoscopy should be undertaken (if patient driving this should be arranged for the next visit), unless a digital photograph has been done within the last 2 months. Women should be advised to keep a record of their pre-pregnancy insulin doses. It should be explained that insulin requirements are likely to change during the pregnancy: o Initially in the first trimester insulin requirements are relatively stable, depending on the amount of nausea experienced. If morning sickness is a problem, it is often appropriate for them to take their insulin after they have eaten if taking a rapid acting analogue with meals. After 12 weeks and before 20 weeks insulin requirements may drop and recurrent hypoglycaemia can become a problem. Women should be advised to cut back on their insulin. If hypoglycaemia is recurrent or severe, women will be advised that they need to take greater care when driving or operating machinery. In some cases, particularly when awareness is lost women are advised not to drive for a period of time. o As the pregnancy progresses into the second trimester, insulin requirements rise and continue to increase until about 34 weeks. Women must increase their insulin as they see their blood glucose values starting to rise. Requirements are often twice the original starting dose and increases may be needed every two to three days. Ultrasound scanning will be performed at approximately 7 weeks gestation to confirm a viable pregnancy. 3 During the pregnancy women will be seen at 1-4 weekly intervals in the first and second trimester and 1-2 weekly in the third trimester, depending on glycaemic control and circumstances. Women will be advised to carry out at least 4 blood glucose measurements per day. Target blood glucose readings should be between 4 - 6 mmol/l before meals and < 8 mmol/l two hours post prandially. Fructosamine blood tests are carried out every 4 weeks with the aim to keep within normal range. The nomal range falls as each trimester occurs. 1st Trimester <285, 2nd 260, 3rd 240. HbA1c will be taken at first visit and in each trimester. Metabolic control will be monitored by reviewing patient’s home blood glucose monitoring diaries and fructosamine results and changes to the insulin regime will be suggested. Women who are on twice daily insulin will be advised to swap to a basal bolus regime after approximately 12+ weeks. Dilated fundoscopy will be undertaken in the first trimester, unless under the care of an ophthalmologist. If normal there is no need to repeat this unless the patient reports visual disturbance. If any changes are seen then dilated fundoscopy should be repeated every trimester. If patient is under an ophthalmologist they should be informed that the patient is pregnant and asked whether earlier review is required. Proteinuria should be assessed by dipstick at regular intervals and quantified where appropriate. An MSU should be sent to first exclude infection. If more than 1+ confirmed on two samples a 24 hour collection should be taken and repeated at four weekly intervals. From 24 weeks gestation ultrasound scans will be performed to assess fetal growth, every 2-4 weeks. Recurrent or severe hypoglycaemia during the latter part of the third trimester raises the possibility of placental insufficiency, therefore a reduction in insulin requirement by 15-20% over a 1-2 day period should not be ignored and patient should be reviewed by the obstetric team, with a view for admission for observation. It is expected that the gestational period will not go beyond 38 weeks gestation due to the increased risk of late intra-uterine death. 4 Management During Labour When admitted the obstetric registrar and the diabetes team must be informed. It is enough to inform the diabetes nurse by leaving a message on her answer phone (4198) or if more urgent help is required she can be contacted via her bleep (7721). If help is required out of hours, the medical registrar on call should be contacted via switchboard. If necessary one of the diabetes consultants can be contacted through switchboard. Spontaneous Onset of Labour As soon as labour is confirmed a suitable insulin regime (below) should be prescribed. An insulin infusion will be commenced through a syringe pump containing 50 units of actrapid in 50ml of N-saline. A 500ml infusion of 5% dextrose with 10mmol potassium if K+ less than 4mmol/l should run simultaneously over 5 hours. Blood Glucose (meter) Infusion Rate (Units/hour) <4.0 4.0 – 6.5 6.6 – 8.9 9.0 – 11.0 11.1 – 17.0 17.1 – 28.0 >28 0 (recheck blood glucose in 30 minutes) 1 2 4 5 6 (call doctor) 8 (call doctor) Potassium should be checked before the infusion is commenced and then 6-8 hourly, if further infusion is required. If potassium levels are outside the range of 3.5-5mmol/l it may be necessary to alter the amount of KCl in the dextrose bag (below) Potassium (mmol/l) <3.5 >5.0 Action 20mmol per bag No potassium in bag Blood glucose should be checked hourly until delivery. If failing to achieve target of 4.5-6, check syringe pump and if everything is working, double insulin infusion rates for each gradient. 5 If blood glucose remains persistently low, change to 10% dextrose. If blood glucose >17mmol/l, check laboratory blood glucose and check urine for ketones, if >1+ and/or if blood glucose confirmed change infusion to N-saline, and contact the medical team. Induction of Labour The induction should be booked in the labour ward diary and arranged in liaison with the diabetes and paediatric departments. Women should be admitted on the day of induction having had their meal and usual insulin. As labour is established the intravenous regime of insulin and dextrose should be started. First Stage of Labour The obstetric registrar should be informed if progress is slow. If secondary arrest of labour occurs in a multiparous diabetic woman syntocinon should not be used unless specifically authorized by the consultant on call because of the risk of fetal macrosomia. Second Stage of Labour Should be allowed to proceed as for a normal labour. Paediatrician should be informed and attend the delivery. Obstetric registrar should be informed if second stage of labour exceeds one hour in a multigravida or 2 hours in a primigravida unless delivery is imminent. Elective Caesarean Section (i) Morning lists The section should be booked in the labour ward diary and arranged in liaison with the diabetes, anaesthetic and paediatric departments. The woman should be admitted the night before the planned section and should receive her normal evening dose of insulin. From midnight she should be “nil by mouth” and her morning dose of insulin omitted. 6 The intravenous regime of insulin and dextrose should be started at least one hour before the planned section and no later than 08.30. Blood glucose should be checked ½ to one hourly until stable. A paediatrician should be informed and attend the delivery. (ii) Afternoon lists The woman may be admitted at 8am on the morning of the planned surgery She may have a light breakfast and appropriate insulin before leaving home After this she should be ‘nil by mouth’ The intravenous regime of insulin and dextrose should be started at least one hour before the planned section and sooner if the woman becomes hypoglycaemic. Blood glucose should be checked ½ to one hourly until stable. A paediatrician should be informed and attend the delivery Post-Natal Management Continue the insulin infusion until patient is eating, if blood glucose levels low halve the infusion rate. Continue to monitor blood glucose hourly for at least 4 hours, then 2-4 hourly until mother is eating normally. When stopping the infusion administer subcutaneous insulin 30 minutes beforehand, with food. The subcutaneous insulin dose should be approximately 75% of the prepregnancy insulin dose (this is the insulin doses she was using prior to conception, not prior to delivery). In the first two weeks after delivery insulin levels may need to be cut further, but tend to rise back to pre-pregnancy levels after this period of time If breast feeding women should be advised to eat an extra 30-50g of carbohydrate per day. When feeding during the night it is advised to have a small carbohydrate snack with each feed. 7 Tight glycaemic control should not be employed in the immediate post-natal period and target blood glucose readings should be 4-8mmol/l pre-prandially. Ideally the mother and her insulin regime should be reviewed by a member of the diabetes team prior to mother and baby being discharged. The mother’s glycaemic control and insulin regime is reviewed at the post natal clinic visit which should be arranged 6 weeks post delivery. Fructosamine should be checked 5 weeks after delivery so that result is available in clinic Further diabetes follow up for the mother should be arranged at the general diabetes outpatient clinic. 8 TYPE 2 DIABETES Background In the CEMACH study (2005), type 2 diabetes was found to account for over 25% of all pre-gestational diabetic pregnancies. It was strongly associated with social deprivation and being a member of an ethnic minority group. It was found that pregnancy in women with type 2 diabetes carried as great a risk of an adverse outcome as in those with type 1 diabetes. Pre-conceptual and Antenatal Management All patients with type 2 diabetes planning a pregnancy should be referred to the diabetes service before contemplating conception. They should all be blood glucose monitoring Target blood glucose are as in type 1 patients and HbA1c should be <7% but preferably lower (<6.5%) Insulin Treated Generally the management of women with type 2 diabetes managed with insulin will follow that of women with type 1 diabetes. Tablet Treated In patients usually managed with tablets, plans will be advised to switch to a basal bolus insulin regime pre-conceptually. If pregnancy is unplanned, the woman should be seen as soon as pregnancy is confirmed and transferred to insulin at that point. Throughout the pregnancy, patients will then be treated in the same way as those with type 1 diabetes. Diet Treated It is likely that women in this group will need insulin at some stage of their pregnancy. 9 They should be seen in the joint clinic as soon as pregnancy is confirmed so that they can be closely monitored and insulin started as soon as necessary. Women will be treated in a similar fashion to those with type 1 diabetes. Management During Labour The management of women with type 2 diabetes during labour should be exactly the same as those with type 1 diabetes. Post-Natal Management Insulin Treated Women with type 2 diabetes treated with insulin prior to pregnancy should be treated in the same way as those with type 1 diabetes. Tablet Treated Breast Feeding Patients who wish to breast feed who were treated with tablets pre-conceptually will need to remain on an insulin regime, and should be treated in the same way as those with type 1 diabetes. They should be advised to return to 75% of their pre-pregnancy doses (or initial pregnancy doses if not commenced on insulin until pregnant) Tight glycaemic control should not be employed in the immediate post-natal period and target blood glucose readings should be 4-8mmol/l pre prandially. Ideally the mother and her insulin regime should be reviewed by a member of the diabetes team prior to mother and baby being discharged. The mother’s glycaemic control and insulin regime is reviewed at the post natal clinic visit which should be arranged 6 weeks post delivery. Fructosamine should be checked 5 weeks after delivery so that result is available in clinic Further diabetes follow up for the mother should be arranged at the general diabetes outpatient clinic. 10 Not Breast Feeding Women not planning to breast feed can have the insulin infusion discontinued soon after delivery. The dextrose infusion should be continued for 1 hour without the insulin. Blood glucose monitoring pre and 2 hours post prandially should be performed for 48 hours post delivery aiming for values of 5-7 pre-prandially and 6-10 post prandially. Usual diabetes medication should be commenced as soon as the woman is eating normally. If blood glucose values are persistently >9mmol/l pre-prandially or >11mmol/l post-prandially, they may require further treatment and diabetes team will need to review prior to discharge. Fructosamine should be checked 5 weeks after delivery so that result is available in clinic The mother’s glycaemic control is reviewed at the post natal clinic visit which should be arranged 6 weeks post delivery. Diet Treated Women able to control diabetes with diet alone prior to pregnancy should be able to return to this. After delivery the insulin infusion should be stopped and dextrose continued for a further hour. Blood glucose monitoring pre and 2 hours post prandially should be performed for 48 hours post delivery aiming for values of 5-7 pre-prandially and 6-10 post prandially. If blood glucose values are persistently >7mmol/l pre-prandially or >10mmol/l post-prandially, they may require further treatment and diabetes team will need to review prior to discharge. The mother’s glycaemic control is reviewed at the post natal clinic visit which should be arranged 6 weeks post delivery. Fructosamine should be checked 5 weeks after delivery so that result is available in clinic 11 MANAGEMENT OF WOMEN WITH IMPAIRED GLUCOSE TOLERANCE IN PREGNANCY/GESTATIONAL DIABETES Background Pregnancy induces a state of insulin resistance which can result in altered glucose handling during pregnancy. Impaired glucose tolerance in pregnancy occurs in up to 2-3% of pregnant women. Worsening insulin resistance and hyperglycaemia generally becomes evident from the second trimester onwards. As with women with diabetes there is an associated increased risk in both maternal and fetal outcome. After pregnancy, once the placenta has been delivered blood glucose levels return to normal in 95% of women with IGT of pregnancy. This figure is slightly lower in those with gestational diabetes. There is a 20-50% chance of developing type 2 diabetes in the next 5-10 years. Screening Glucose tolerance tests should be performed between 26-28 weeks if any of the following risk factors are present: Obese women (BMI >30kg/m2). Women with a first degree relative with diabetes (sibling, mother, father, child, NOT husband). Women with a previous large baby >4.5kg and/or a history of neonatal hypoglycaemia Women with a past history of unexplained intra-uterine death in second or third trimester. Women with glycosuria (2+ or more, or 1+ on more than one occasion). Women with previous history of impaired glucose tolerance in pregnancy, treated by dietary restriction alone. Other women should be screened on the development of unexplained polyhydramnios and macrosomia. Women with polycystic ovarian syndrome. 12 All patients of Indo-Asian origin. Women with previous gestational diabetes/impaired glucose tolerance which required insulin therapy during pregnancy should be screened initially at 18 weeks and if negative again at 26-28 weeks. Notes A glucose tolerance test is not necessary in a woman with unequivocal hyperglycaemia i.e. fasting glucose >7mmol/l or random glucose >11mmol/l on more than one occasion. They should be referred directly to the joint diabetes antenatal clinic as soon as possible. A small number of pregnant women each year present with the classical symptoms and signs of type 1 diabetes (polydipsia, polyuria, weight loss, hyperglycaemia and weight loss, as well as occasionally diabetic ketoacidosis). These women require immediate review and same day referral to the diabetes team. Insulin should be commenced and will need to be continued post delivery. A glucose tolerance test is not necessary in women known to have impaired glucose tolerance prior to pregnancy. They should be referred directly to the joint diabetes antenatal clinic as soon as pregnancy is confirmed. 13 Oral Glucose Tolerance Test 1) The test is performed in the morning after an overnight fast of 8-14 hours during which time only water is allowed. 2) After 30 minutes rest, blood is taken for fasting glucose sample in a fluoride oxalate tube. 3) Patient is given 75g of anhydrous glucose in form of “polycal” liquid to drink 113ml of polycal liquid is measured into a beaker and water added to make up to a volume of 200ml. The solution is mixed thoroughly. This solution is to be consumed over a 5 minute period followed by a further 100ml of plain water. 4) A further blood sample for glucose is taken 2 hours after the glucose load (timing is from the beginning of the drink). 5) During the test the patient is asked to rest and is not allowed anything else to eat and only water to drink. Notes Women should be advised that they need to eat their usual diet in the days leading up to the test and carry out their usual amount of physical activity. If the woman is febrile or acutely unwell, the test should be postponed. Any medication which may interfere with the test should be noted and if possible stopped 3/7 before test. Interpretation of Results (Venous Plasma Samples) Diagnosis of diabetes is based on WHO criteria. Glucose values taken to represent impaired glucose tolerance are lower than WHO criteria, to allow for a further increase in glucose values in the subsequent weeks. This reflects normal practice in diabetes care, and is based on the time when insulin is started. Diabetes Mellitus: &/or Fasting >7.0 mmol/l 2 hour value >11.1 mmol/l &/or Fasting 5.6-6.9 2 hour value 8.5-11.1 & Fasting <5.6 mmol/l 2 hour value <8.5 mmol/l Impaired Glucose Tolerance: Normal Glucose Tolerance: 14 Both values have to be in the normal range for a woman to have “normal glucose tolerance” Therefore any fasting glucose of ≥5.6 mmol/l or any 2 hour value ≥8.5 mmol/l should be referred to the joint diabetes antenatal clinic within 1 week. Antenatal Management of Women with IGT in Pregnancy/Gestational Diabetes During their first visit relevant history will be taken from the woman and an explanation of their diagnosis and potential treatment (i.e. either simple dietary changes or insulin). The woman will be taught by the diabetic specialist nurse to monitor her own blood glucose. Target blood sugars will be 4-6mmol/l before meals and <8 mmol/l 2 hours postprandially. During the first visit, the woman will be seen by a dietician and receive advice regarding dietary modification. During the first visit, the woman should be given the relevant telephone numbers of the diabetes specialist nurses working in her area and the hospital diabetes specialist nurses, so she has someone to call for advice. If the result of the glucose tolerance test is in the diabetic range, she will be asked to monitor blood glucose values for 3/7 and then call the diabetes specialist nurse for advice. Arrangements to start insulin at this point can be made if necessary. The woman will be reviewed one week later to monitor her blood glucose values. If blood glucose values are consistently outside the targets, the woman will be commenced on insulin. This may be only once daily or up to four times daily depending on the results with a usual stating dose of 4 units. The woman will be reviewed 1-2 weekly for the rest of the pregnancy. Ultrasound scans to assess fetal growth will be carried out every 2-4 weeks. Method and timing of delivery will depend on obstetric indications, but woman on insulin are unlikely to go beyond 38 weeks gestation. 15 Management During Labour Insulin Treated Any woman who has required insulin during the pregnancy should be treated in the same was as a woman with type 1 diabetes, using the intravenous regime of insulin and dextrose described earlier. Diet Treated Women who are normally controlled on diet should not require an insulin infusion in labour. Blood glucose should be checked 4 hourly. If the blood glucose > 9mmol/l the intravenous regime of insulin and dextrose should be commenced. Postnatal Management Insulin Treated Following delivery of the placenta the insulin infusion can be stopped immediately. The dextrose should continue for a further hour. Blood glucose monitoring pre and two hours post prandially should be performed for 48 hours post delivery to ensure a return to normoglycaemia. If blood glucose values are persistently >6 mmol/l pre-prandially or >8 mmol/l two hours post-prandially, they may require further treatment and diabetes team will need to review prior to discharge. A glucose tolerance test at 5+ weeks post natal should be booked before discharge. The mother is reviewed at the post natal clinic visit which should be arranged 6 weeks post delivery (after the glucose tolerance test), with reinforcement of the dietary and weight advice. 16 Diet Treated Following delivery blood glucose monitoring pre and 2 hours post prandially should be performed for 48 hours post-delivery to ensure a return to normoglycaemia. If blood glucose values are persistently >6 mmol/l pre-prandially or >8 mmol/l two hours post-prandially, they may require further treatment and diabetes team will need to review prior to discharge. A glucose tolerance test at 5+ weeks post natal should be booked before discharge. The mother is reviewed at the post natal clinic visit which should be arranged 6-8 weeks post delivery (after the glucose tolerance test), with reinforcement of dietary and weight advice. 17 References Confidential Enquiry into Maternal and Child Health (CEMACH; 2005) Pregnancy in women with type 1 and type 2 diabetes. CEMACH, London. McElduff A et al (2005) The Australasian Diabetes in Pregnancy Society Consensus guidelines for the management of type 1 and type 2 diabetes in relation to pregnancy. MJA 183 (7): 373-377. The Vincent Working Party Report (1996) Diabetic Medicine 13(4):42-54. Turner H and Waas J (2002). Diabetes in Pregnancy, Oxford Handbook of Endocrinology and Diabetes. Oxford University Press. WHO (1999) Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. Report of a WHO Consultation Part 1. 18