2Summary of recommendations and algorithm

2.1. Key priorities for implementation (key recommendations)

Chapter 3 Preconception care

Outcomes and risks for the woman and baby

Women with diabetes who are planning to become pregnant should be informed that establishing good glycaemic control before conception and continuing this throughout pregnancy will reduce the risk of miscarriage, congenital malformation, stillbirth and neonatal death. It is important to explain that risks can be reduced but not eliminated.

Importance of planning pregnancy and the role of contraception

The importance of avoiding unplanned pregnancy should be an essential component of diabetes education from adolescence for women with diabetes.

Self-management programmes

Women with diabetes who are planning to become pregnant should be offered preconception care and advice before discontinuing contraception.

Chapter 5 Antenatal care

Target ranges for blood glucose during pregnancy

If it is safely achievable, women with diabetes should aim to keep fasting blood glucose between 3.5 and 5.9 mmol/litre and 1 hour postprandial blood glucose below 7.8 mmol/litre during pregnancy.

Management of diabetes during pregnancy

Women with insulin-treated diabetes should be advised of the risks of hypoglycaemia and hypoglycaemia unawareness in pregnancy, particularly in the first trimester.

During pregnancy, women who are suspected of having diabetic ketoacidosis should be admitted immediately for level 2 critical care*, where they can receive both medical and obstetric care.

Screening for congenital malformations

Women with diabetes should be offered antenatal examination of the four chamber view of the fetal heart and outflow tracts at 18–20 weeks.

Chapter 7 Neonatal care

Initial assessment and criteria for admission to intensive/special care

Babies of women with diabetes should be kept with their mothers unless there is a clinical complication or there are abnormal clinical signs that warrant admission for intensive or special care.

Chapter 8 Postnatal care

Information and follow-up after birth

Women who were diagnosed with gestational diabetes should be offered lifestyle advice (including weight control, diet and exercise) and offered a fasting plasma glucose measurement (but not an oral glucose tolerance test) at the 6 week postnatal check and annually thereafter.

2.2. Summary of recommendations

Chapter 3 Preconception care

Outcomes and risks for the woman and baby

Healthcare professionals should seek to empower women with diabetes to make the experience of pregnancy and childbirth a positive one by providing information, advice and support that will help to reduce the risks of adverse pregnancy outcomes for mother and baby.

Women with diabetes who are planning to become pregnant should be informed that establishing good glycaemic control before conception and continuing this throughout pregnancy will reduce the risk of miscarriage, congenital malformation, stillbirth and neonatal death. It is important to explain that risks can be reduced but not eliminated.

Women with diabetes who are planning to become pregnant and their families should be offered information about how diabetes affects pregnancy and how pregnancy affects diabetes. The information should cover:

  • the role of diet, body weight and exercise
  • the risks of hypoglycaemia and hypoglycaemia unawareness during pregnancy
  • how nausea and vomiting in pregnancy can affect glycaemic control
  • the increased risk of having a baby who is large for gestational age, which increases the likelihood of birth trauma, induction of labour and caesarean section
  • the need for assessment of diabetic retinopathy before and during pregnancy
  • the need for assessment of diabetic nephropathy before pregnancy
  • the importance of maternal glycaemic control during labour and birth and early feeding of the baby in order to reduce the risk of neonatal hypoglycaemia
  • the possibility of transient morbidity in the baby during the neonatal period, which may require admission to the neonatal unit
  • the risk of the baby developing obesity and/or diabetes in later life.

The importance of planning pregnancy and the role of contraception

The importance of avoiding unplanned pregnancy should be an essential component of diabetes education from adolescence for women with diabetes.

Women with diabetes who are planning to become pregnant should be advised:

  • that the risks associated with pregnancies complicated by diabetes increase with the duration of diabetes
  • to use contraception until good glycaemic control (assessed by HbA1c**) has been established
  • that glycaemic targets, glucose monitoring, medications for diabetes (including insulin regimens for insulin-treated diabetes) and medications for complications of diabetes will need to be reviewed before and during pregnancy
  • that additional time and effort is required to manage diabetes during pregnancy and that there will be frequent contact with healthcare professionals. Women should be given information about the local arrangements for support, including emergency contact numbers.

Diet, dietary supplements, body weight and exercise

Women with diabetes who are planning to become pregnant should be offered individualised dietary advice.

Women with diabetes who are planning to become pregnant and who have a body mass index above 27 kg/m2 should be offered advice on how to lose weight in line with ‘Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children’ (NICE clinical guideline 43), available from www.nice.org.uk/CG043.

Women with diabetes who are planning to become pregnant should be advised to take folic acid (5 mg/day) until 12 weeks of gestation to reduce the risk of having a baby with a neural tube defect.

Target ranges for blood glucose in the preconception period

Individualised targets for self-monitoring of blood glucose should be agreed with women who have diabetes and are planning to become pregnant, taking into account the risk of hypoglycaemia.

If it is safely achievable, women with diabetes who are planning to become pregnant should aim to maintain their HbA1c below 6.1%. Women should be reassured that any reduction in HbA1c towards the target of 6.1% is likely to reduce the risk of congenital malformations.

Women with diabetes whose HbA1c is above 10% should be strongly advised to avoid pregnancy.

Monitoring blood glucose and ketones in the preconception period

Women with diabetes who are planning to become pregnant should be offered monthly measurement of HbA1c.

Women with diabetes who are planning to become pregnant should be offered a meter for self-monitoring of blood glucose.

Women with diabetes who are planning to become pregnant and who require intensification of hypoglycaemic therapy should be advised to increase the frequency of self-monitoring of blood glucose to include fasting and a mixture of pre- and postprandial levels.

Women with type 1 diabetes who are planning to become pregnant should be offered ketone testing strips and advised to test for ketonuria or ketonaemia if they become hyperglycaemic or unwell.

The safety of medications for diabetes before and during pregnancy

Women with diabetes may be advised to use metformin*** as an adjunct or alternative to insulin in the preconception period and during pregnancy, when the likely benefits from improved glycaemic control outweigh the potential for harm. All other oral hypoglycaemic agents should be discontinued before pregnancy and insulin substituted.

Healthcare professionals should be aware that data from clinical trials and other sources do not suggest that the rapid-acting insulin analogues (aspart and lispro) adversely affect the pregnancy or the health of the fetus or newborn baby.

Women with insulin-treated diabetes who are planning to become pregnant should be informed that there is insufficient evidence about the use of long-acting insulin analogues during pregnancy. Therefore isophane insulin (also known as NPH insulin) remains the first choice for long-acting insulin during pregnancy.

The safety of medications for diabetic complications before and during pregnancy

Angiotensin-converting enzyme inhibitors and angiotensin-II receptor antagonists should be discontinued before conception or as soon as pregnancy is confirmed. Alternative antihypertensive agents suitable for use during pregnancy should be substituted.

Statins should be discontinued before pregnancy or as soon as pregnancy is confirmed.

Removing barriers to the uptake of preconception care and when to offer information

Women with diabetes should be informed about the benefits of preconception glycaemic control at each contact with healthcare professionals, including their diabetes care team, from adolescence.

The intentions of women with diabetes regarding pregnancy and contraceptive use should be documented at each contact with their diabetes care team from adolescence.

Preconception care for women with diabetes should be given in a supportive environment and the woman’s partner or other family member should be encouraged to attend.

Self-management programmes

Women with diabetes who are planning to become pregnant should be offered a structured education programme as soon as possible if they have not already attended one (see ‘Guidance on the use of patient-education models for diabetes’ [NICE technology appraisal guidance 60], available from www.nice.org.uk/TA060.

Women with diabetes who are planning to become pregnant should be offered preconception care and advice before discontinuing contraception.

Retinal assessment in the preconception period

Women with diabetes seeking preconception care should be offered retinal assessment at their first appointment (unless an annual retinal assessment has occurred within the previous 6 months) and annually thereafter if no diabetic retinopathy is found.

Retinal assessment should be carried out by digital imaging with mydriasis using tropicamide, in line with the UK National Screening Committee’s recommendations for annual mydriatic two-field digital photographic screening as part of a systematic screening programme.

Women with diabetes who are planning to become pregnant should be advised to defer rapid optimisation of glycaemic control until after retinal assessment and treatment have been completed.

Renal assessment in the preconception period

Women with diabetes should be offered a renal assessment, including a measure of microalbuminuria, before discontinuing contraception. If serum creatinine is abnormal (120 micromol/litre or more), or the estimated glomerular filtration rate (eGFR) is less than 45 ml/minute/1.73 m2, referral to a nephrologist should be considered before discontinuing contraception.

Chapter 4 Gestational diabetes

Risk factors for gestational diabetes

Healthcare professionals should be aware that the following have been shown to be independent risk factors for gestational diabetes:

  • body mass index above 30 kg/m2
  • previous macrosomic baby weighing 4.5 kg or above
  • previous gestational diabetes
  • family history of diabetes (first-degree relative with diabetes)
  • family origin with a high prevalence of diabetes:

    South Asian (specifically women whose country of family origin is India, Pakistan or Bangladesh)

    black Caribbean

    Middle Eastern (specifically women whose country of family origin is Saudi Arabia, United Arab Emirates, Iraq, Jordan, Syria, Oman, Qatar, Kuwait, Lebanon or Egypt).

Screening, diagnosis, and treatment for gestational diabetes

Screening for gestational diabetes using risk factors is recommended in a healthy population. At the booking appointment, the following risk factors for gestational diabetes should be determined:††

  • body mass index above 30 kg/m2
  • previous macrosomic baby weighing 4.5 kg or above
  • previous gestational diabetes
  • family history of diabetes (first-degree relative with diabetes)
  • family origin with a high prevalence of diabetes:

    South Asian (specifically women whose country of family origin is India, Pakistan or Bangladesh)

    black Caribbean

    Middle Eastern (specifically women whose country of family origin is Saudi Arabia, United Arab Emirates, Iraq, Jordan, Syria, Oman, Qatar, Kuwait, Lebanon or Egypt).

Women with any one of these risk factors should be offered testing for gestational diabetes.

In order to make an informed decision about screening and testing for gestational diabetes, women should be informed that:****

  • in most women, gestational diabetes will respond to changes in diet and exercise
  • some women (between 10% and 20%) will need oral hypoglycaemic agents or insulin therapy if diet and exercise are not effective in controlling gestational diabetes
  • if gestational diabetes is not detected and controlled there is a small risk of birth complications such as shoulder dystocia
  • a diagnosis of gestational diabetes may lead to increased monitoring and interventions during both pregnancy and labour.

Screening for gestational diabetes using fasting plasma glucose, random blood glucose, glucose challenge test and urinalysis for glucose should not be undertaken.****

The 2 hour 75 g oral glucose tolerance test (OGTT) should be used to test for gestational diabetes and diagnosis made using the criteria defined by the World Health Organization†††. Women who have had gestational diabetes in a previous pregnancy should be offered early self-monitoring of blood glucose or OGTT at 16–18 weeks, and a further OGTT at 28 weeks if the results are normal. Women with any of the other risk factors for gestational diabetes should be offered an OGTT at 24–28 weeks.

Women with gestational diabetes should be instructed in self-monitoring of blood glucose. Targets for blood glucose control should be determined in the same way as for women with pre-existing diabetes.

Women with gestational diabetes should be informed that good glycaemic control throughout pregnancy will reduce the risk of fetal macrosomia, trauma during birth (to themselves and the baby), induction of labour or caesarean section, neonatal hypoglycaemia and perinatal death.

Women with gestational diabetes should be offered information covering:

  • the role of diet, body weight and exercise
  • the increased risk of having a baby who is large for gestational age, which increases the likelihood of birth trauma, induction of labour and caesarean section
  • the importance of maternal glycaemic control during labour and birth and early feeding of the baby in order to reduce the risk of neonatal hypoglycaemia
  • the possibility of transient morbidity in the baby during the neonatal period, which may require admission to the neonatal unit
  • the risk of the baby developing obesity and/or diabetes in later life.

Women with gestational diabetes should be advised to choose, where possible, carbohydrates from low glycaemic index sources, lean proteins including oily fish and a balance of polyunsaturated fats and monounsaturated fats.

Women with gestational diabetes whose pre-pregnancy body mass index was above 27 kg/m2 should be advised to restrict calorie intake (to 25 kcal/kg/day or less) and to take moderate exercise (of at least 30 minutes daily).

Hypoglycaemic therapy should be considered for women with gestational diabetes if diet and exercise fail to maintain blood glucose targets during a period of 1–2 weeks.

Hypoglycaemic therapy should be considered for women with gestational diabetes if ultrasound investigation suggests incipient fetal macrosomia (abdominal circumference above the 70th percentile) at diagnosis.

Hypoglycaemic therapy for women with gestational diabetes (which may include regular insulin, rapid-acting insulin analogues [aspart and lispro] and/or hypoglycaemic agents [metformin and glibenclamide§] should be tailored to the glycaemic profile of, and acceptability to, the individual woman.

Chapter 5 Antenatal care

Target ranges for blood glucose during pregnancy

Individualised targets for self-monitoring of blood glucose should be agreed with women with diabetes in pregnancy, taking into account the risk of hypoglycaemia.

If it is safely achievable, women with diabetes should aim to keep fasting blood glucose between 3.5 and 5.9 mmol/litre and 1 hour postprandial blood glucose below 7.8 mmol/litre during pregnancy.

HbA1c should not be used routinely for assessing glycaemic control in the second and third trimesters of pregnancy.

Monitoring blood glucose and ketones during pregnancy

Women with diabetes should be advised to test fasting blood glucose levels and blood glucose levels 1 hour after every meal during pregnancy.

Women with insulin-treated diabetes should be advised to test blood glucose levels before going to bed at night during pregnancy.

Women with type 1 diabetes who are pregnant should be offered ketone testing strips and advised to test for ketonuria or ketonaemia if they become hyperglycaemic or unwell.

Management of diabetes during pregnancy

Healthcare professionals should be aware that the rapid-acting insulin analogues (aspart and lispro) have advantages over soluble human insulin during pregnancy and should consider their use.

Women with insulin-treated diabetes should be advised of the risks of hypoglycaemia and hypoglycaemia unawareness in pregnancy, particularly in the first trimester.

During pregnancy, women with insulin-treated diabetes should be provided with a concentrated glucose solution and women with type 1 diabetes should also be given glucagon; women and their partners or other family members should be instructed in their use.

During pregnancy, women with insulin-treated diabetes should be offered continuous subcutaneous insulin infusion (CSII or insulin pump therapy) if adequate glycaemic control is not obtained by multiple daily injections of insulin without significant disabling hypoglycaemia.§§

During pregnancy, women with type 1 diabetes who become unwell should have diabetic ketoacidosis excluded as a matter of urgency.

During pregnancy, women who are suspected of having diabetic ketoacidosis should be admitted immediately for level 2 critical care††††, where they can receive both medical and obstetric care.

Retinal assessment during pregnancy

Pregnant women with pre-existing diabetes should be offered retinal assessment by digital imaging with mydriasis using tropicamide following their first antenatal clinic appointment and again at 28 weeks if the first assessment is normal. If any diabetic retinopathy is present, an additional retinal assessment should be performed at 16–20 weeks.

If retinal assessment has not been performed in the preceding 12 months, it should be offered as soon as possible after the first contact in pregnancy in women with pre-existing diabetes.

Diabetic retinopathy should not be considered a contraindication to rapid optimisation of glycaemic control in women who present with a high HbA1c in early pregnancy.

Women who have preproliferative diabetic retinopathy diagnosed during pregnancy should have ophthalmological follow-up for at least 6 months following the birth of the baby.

Diabetic retinopathy should not be considered a contraindication to vaginal birth.

Renal assessment during pregnancy

If renal assessment has not been undertaken in the preceding 12 months in women with pre-existing diabetes, it should be arranged at the first contact in pregnancy. If serum creatinine is abnormal (120 micromol/litre or more) or if total protein excretion exceeds 2 g/day, referral to a nephrologist should be considered (eGFR should not be used during pregnancy). Thromboprophylaxis should be considered for women with proteinuria above 5 g/day (macroalbuminuria).

Screening for congenital malformations

Women with diabetes should be offered antenatal examination of the four chamber view of the fetal heart and outflow tracts at 18–20 weeks.

Monitoring fetal growth and wellbeing

Pregnant women with diabetes should be offered ultrasound monitoring of fetal growth and amniotic fluid volume every 4 weeks from 28 to 36 weeks.

Routine monitoring of fetal wellbeing before 38 weeks is not recommended in pregnant women with diabetes, unless there is a risk of intrauterine growth restriction.

Women with diabetes and a risk of intrauterine growth restriction (macrovascular disease and/or nephropathy) will require an individualised approach to monitoring fetal growth and wellbeing.

Timetable of antenatal appointments

Women with diabetes who are pregnant should be offered immediate contact with a joint diabetes and antenatal clinic.

Women with diabetes should have contact with the diabetes care team for assessment of glycaemic control every 1–2 weeks throughout pregnancy.

Antenatal appointments for women with diabetes should provide care specifically for women with diabetes, in addition to the care provided routinely for healthy pregnant women (see ‘Antenatal care: routine care for the healthy pregnant woman’ [NICE clinical guideline 62], available from www.nice.org.uk/CG062). Table 5.7 describes where care for women with diabetes differs from routine antenatal care. At each appointment women should be offered ongoing opportunities for information and education.

Table 5.7. Specific antenatal care for women with diabetes.

Table 5.7

Specific antenatal care for women with diabetes.

Preterm labour in women with diabetes

Diabetes should not be considered a contraindication to antenatal steroids for fetal lung maturation or to tocolysis.

Women with insulin-treated diabetes who are receiving steroids for fetal lung maturation should have additional insulin according to an agreed protocol and should be closely monitored.

Betamimetic drugs should not be used for tocolysis in women with diabetes.

Chapter 6 Intrapartum care

Timing and mode of birth

Pregnant women with diabetes who have a normally grown fetus should be offered elective birth through induction of labour, or by elective caesarean section if indicated, after 38 completed weeks.

Diabetes should not in itself be considered a contraindication to attempting vaginal birth after a previous caesarean section.

Pregnant women with diabetes who have an ultrasound-diagnosed macrosomic fetus should be informed of the risks and benefits of vaginal birth, induction of labour and caesarean section.

Analgesia and anaesthesia

Women with diabetes and comorbidities such as obesity or autonomic neuropathy should be offered an anaesthetic assessment in the third trimester of pregnancy.

If general anaesthesia is used for the birth in women with diabetes, blood glucose should be monitored regularly (every 30 minutes) from induction of general anaesthesia until after the baby is born and the woman is fully conscious.

Glycaemic control during labour and birth

During labour and birth, capillary blood glucose should be monitored on an hourly basis in women with diabetes and maintained at between 4 and 7 mmol/litre.

Women with type 1 diabetes should be considered for intravenous dextrose and insulin infusion from the onset of established labour.

Intravenous dextrose and insulin infusion is recommended during labour and birth for women with diabetes whose blood glucose is not maintained at between 4 and 7 mmol/litre.

Chapter 7 Neonatal care

Initial assessment and criteria for admission to intensive or special care

Women with diabetes should be advised to give birth in hospitals where advanced neonatal resuscitation skills are available 24 hours a day.

Babies of women with diabetes should be kept with their mothers unless there is a clinical complication or there are abnormal clinical signs that warrant admission for intensive or special care.

Blood glucose testing should be carried out routinely in babies of women with diabetes at 2–4 hours after birth. Blood tests for polycythaemia, hyperbilirubinaemia, hypocalcaemia and hypomagnesaemia should be carried out for babies with clinical signs.

Babies of women with diabetes should have an echocardiogram performed if they show clinical signs associated with congenital heart disease or cardiomyopathy, including heart murmur. The timing of the examination will depend on the clinical circumstances.

Babies of women with diabetes should be admitted to the neonatal unit if they have:

  • hypoglycaemia associated with abnormal clinical signs
  • respiratory distress
  • signs of cardiac decompensation due to congenital heart disease or cardiomyopathy
  • signs of neonatal encephalopathy
  • signs of polycythaemia and are likely to need partial exchange transfusion
  • need for intravenous fluids
  • need for tube feeding (unless adequate support is available on the postnatal ward)
  • jaundice requiring intense phototherapy and frequent monitoring of bilirubinaemia
  • been born before 34 weeks (or between 34 and 36 weeks if dictated clinically by the initial assessment of the baby and feeding on the labour ward).

Babies of women with diabetes should not be transferred to community care until they are at least 24 hours old, and not before healthcare professionals are satisfied that the babies are maintaining blood glucose levels and are feeding well.

Prevention and assessment of neonatal hypoglycaemia

All maternity units should have a written policy for the prevention, detection and management of hypoglycaemia in babies of women with diabetes.

Babies of women with diabetes should have their blood glucose tested using a quality-assured method validated for neonatal use (ward-based glucose electrode or laboratory analysis).

Babies of women with diabetes should feed as soon as possible after birth (within 30 minutes) and then at frequent intervals (every 2–3 hours) until feeding maintains pre-feed blood glucose levels at a minimum of 2.0 mmol/litre.

If blood glucose values are below 2.0 mmol/litre on two consecutive readings despite maximal support for feeding, if there are abnormal clinical signs or if the baby will not feed orally effectively, additional measures such as tube feeding or intravenous dextrose should be given. Additional measures should only be implemented if one or more of these criteria are met.

Babies of women with diabetes who present with clinical signs of hypoglycaemia should have their blood glucose tested and be treated with intravenous dextrose as soon as possible.

Chapter 8 Postnatal care

Breastfeeding and effects on glycaemic control

Women with insulin-treated pre-existing diabetes should reduce their insulin immediately after birth and monitor their blood glucose levels carefully to establish the appropriate dose.

Women with insulin-treated pre-existing diabetes should be informed that they are at increased risk of hypoglycaemia in the postnatal period, especially when breastfeeding, and they should be advised to have a meal or snack available before or during feeds.

Women who have been diagnosed with gestational diabetes should discontinue hypoglycaemic treatment immediately after birth.

Women with pre-existing type 2 diabetes who are breastfeeding can resume or continue to take metformin§§§ and glibenclamide‡‡ immediately following birth but other oral hypoglycaemic agents should be avoided while breastfeeding.

Women with diabetes who are breastfeeding should continue to avoid any drugs for the treatment of diabetes complications that were discontinued for safety reasons in the preconception period.

Information and follow-up after birth

Women with pre-existing diabetes should be referred back to their routine diabetes care arrangements.

Women who were diagnosed with gestational diabetes should have their blood glucose tested to exclude persisting hyperglycaemia before they are transferred to community care.

Women who were diagnosed with gestational diabetes should be reminded of the symptoms of hyperglycaemia.

Women who were diagnosed with gestational diabetes should be offered lifestyle advice (including weight control, diet and exercise) and offered a fasting plasma glucose measurement (but not an OGTT) at the 6 week postnatal check and annually thereafter.

Women who were diagnosed with gestational diabetes (including those with ongoing impaired glucose regulation) should be informed about the risks of gestational diabetes in future pregnancies and they should be offered screening (OGTT or fasting plasma glucose) for diabetes when planning future pregnancies.

Women who were diagnosed with gestational diabetes (including those with ongoing impaired glucose regulation) should be offered early self-monitoring of blood glucose or an OGTT in future pregnancies. A subsequent OGTT should be offered if the test results in early pregnancy are normal.

Women with diabetes should be reminded of the importance of contraception and the need for preconception care when planning future pregnancies.

2.3. Key priorities for research

Chapter 4 Gestational diabetes

Screening, diagnosis and treatment for gestational diabetes

What is the clinical and cost-effectiveness of the three main available screening techniques for gestational diabetes: risk factors, two-stage screening by the glucose challenge test and OGTT, and universal OGTT (with or without fasting)?

Why this is important

Following the Australian carbohydrate intolerance study in pregnant women (ACHOIS) it seems that systematic screening for gestational diabetes may be beneficial to the UK population. A multicentre randomised controlled trial is required to test the existing screening techniques, which have not been systematically evaluated for clinical and cost-effectiveness (including acceptability) within the UK.

Chapter 5 Antenatal care

Monitoring blood glucose and ketones during pregnancy

How effective is ambulatory continuous blood glucose monitoring in pregnancies complicated by diabetes?

Why this is important

The technology for performing ambulatory continuous blood glucose monitoring is only just becoming available, so there is currently no evidence to assess its effectiveness outside the laboratory situation. Research is needed to determine whether the technology is likely to have a place in the clinical management of diabetes in pregnancy. The new technology may identify women in whom short-term postprandial peaks of glycaemia are not detected by intermittent blood glucose testing. The aim of monitoring is to adjust insulin regimens to reduce the incidence of adverse outcomes of pregnancy (for example, fetal macrosomia, caesarean section and neonatal hypoglycaemia), so these outcomes should be assessed as part of the research.

Management of diabetes during pregnancy

Do new-generation continuous subcutaneous insulin infusion (CSII) pumps offer an advantage over traditional intermittent insulin injections in terms of pregnancy outcomes in women with type 1 diabetes?

Why this is important

Randomised controlled trials have shown no advantage or disadvantage of using CSII pumps over intermittent insulin injections in pregnancy. A new generation of CSII pumps may offer technological advantages that would make a randomised controlled trial appropriate, particularly with the availability of insulin analogues (which may have improved the effectiveness of intermittent insulin injections).

Monitoring fetal growth and wellbeing

How can the fetus at risk of intrauterine death be identified in women with diabetes?

Why this is important

Unheralded intrauterine death remains a significant contributor to perinatal mortality in pregnancies complicated by diabetes. Conventional tests of fetal wellbeing (umbilical artery Doppler ultrasound, cardiotocography and other biophysical tests) have been shown to have poor sensitivity for predicting such events. Alternative approaches that include measurements of liquor erythropoietin and magnetic resonance imaging spectroscopy may be effective, but there is currently insufficient clinical evidence to evaluate them. Well-designed randomised controlled trials that are sufficiently powered are needed to determine whether these approaches are clinically and cost-effective.

Chapter 6 Intrapartum care

Glycaemic control during labour and birth

What is the optimal method for controlling glycaemia during labour and birth?

Why this is important

Epidemiological studies have shown that poor glycaemic control during labour and birth is associated with adverse neonatal outcomes (in particular, neonatal hypoglycaemia and respiratory distress). However, no randomised controlled trials have compared the effectiveness of intermittent subcutaneous insulin injections and/or CSII with that of intravenous dextrose plus insulin during labour and birth. The potential benefits of intermittent insulin injections and/or CSII over intravenous dextrose plus insulin during the intrapartum period include patient preference due to the psychological effect of the woman feeling in control of her diabetes and having increased mobility. Randomised controlled trials are therefore needed to evaluate the safety of intermittent insulin injections and/or CSII during labour and birth compared with that of intravenous dextrose plus insulin.

2.4. Summary of research recommendations

Chapter 3 Preconception care

Self-management programmes

What is the most clinically and cost-effective form of preconception care and advice for women with diabetes?

Why this is important

Preconception care and advice for women with pre-existing diabetes is recommended because a health economic analysis has demonstrated cost-effectiveness of attendance at a preconception clinic. Due to limitations in the clinical evidence available to inform the health economic modelling it was not possible to establish the optimal form of preconception care and advice for this group of women. Future research should seek to establish the clinical and cost-effectiveness of different models of preconception care and advice for women with pre-existing diabetes. Specifically it should evaluate different forms of content (i.e. what topics are covered), frequency and timing of contact with healthcare professionals (for example, whether one long session is more clinically and cost-effective than a series of shorter sessions), which healthcare professionals should be involved (for example, whether preconception care and advice provided by a multidisciplinary team is more clinically and cost-effective than contact with one healthcare professional), and format (for example, whether group sessions are more clinically and cost-effective than providing care and advice for each woman separately). The research should also seek to establish whether women with type 1 and type 2 diabetes have different needs in terms of preconception care and advice, and how different models of care and advice compare to structured education programmes already offered to women with type 1 and type 2 diabetes.

Chapter 4 Gestational diabetes

Screening, diagnosis and treatment for gestational diabetes

What is the clinical and cost-effectiveness of the three main available screening techniques for gestational diabetes: risk factors, two-stage screening by the glucose challenge test and OGTT, and universal OGTT (with or without fasting)?

Why this is important

Following the Australian carbohydrate intolerance study in pregnant women (ACHOIS) it seems that systematic screening for gestational diabetes may be beneficial to the UK population. A multicentre randomised controlled trial is required to test the existing screening techniques, which have not been systematically evaluated for clinical and cost-effectiveness (including acceptability) within the UK.

Chapter 5 Antenatal care

Monitoring blood glucose and ketones during pregnancy

How effective is ambulatory continuous blood glucose monitoring in pregnancies complicated by diabetes?

Why this is important

The technology for performing ambulatory continuous blood glucose monitoring is only just becoming available, so there is currently no evidence to assess its effectiveness outside the laboratory situation. Research is needed to determine whether the technology is likely to have a place in the clinical management of diabetes in pregnancy. The new technology may identify women in whom short-term postprandial peaks of glycaemia are not detected by intermittent blood glucose testing. The aim of monitoring is to adjust insulin regimens to reduce the incidence of adverse outcomes of pregnancy (for example, fetal macrosomia, caesarean section and neonatal hypoglycaemia), so these outcomes should be assessed as part of the research.

Management of diabetes during pregnancy

Do new-generation continuous subcutaneous insulin infusion (CSII) pumps offer an advantage over traditional intermittent insulin injections in terms of pregnancy outcomes in women with type 1 diabetes?

Why this is important

Randomised controlled trials have shown no advantage or disadvantage of using CSII pumps over intermittent insulin injections in pregnancy. A new generation of CSII pumps may offer technological advantages that would make a randomised controlled trial appropriate, particularly with the availability of insulin analogues (which may have improved the effectiveness of intermittent insulin injections).

Retinal assessment during pregnancy

Should retinal assessment during pregnancy be offered to women diagnosed with gestational diabetes who are suspected of having pre-existing diabetes?

Why this is important

Women with gestational diabetes may have previously unrecognised type 2 diabetes with retinopathy. At present this is not screened for because of the difficulty in identifying these women amongst the larger group who have reversible gestational diabetes. The benefit of recognising such women is that treatment for diabetic retinopathy is available and could prevent short- or long-term deterioration of visual acuity. The research needed would be an observational study of retinal assessment in women newly diagnosed with gestational diabetes to determine whether there is a significant amount of retinal disease present. The severity of any abnormality detected might identify women most at risk for appropriate retinal assessment.

Renal assessment during pregnancy

Does identification of microalbuminuria during pregnancy offer the opportunity for appropriate pharmacological treatment to prevent progression to pre-eclampsia in women with pre-existing diabetes?

Why this is important

Microalbuminuria testing is available, but it is not performed routinely in antenatal clinics for women with pre-existing diabetes because a place for prophylactic treatment of pre-eclampsia in microalbuminuria-positive women has not been investigated. The benefit of clinically and cost-effective prophylactic treatment would be to significantly improve pregnancy outcomes in this group of women.

Screening for congenital malformations

How reliable is first-trimester screening for Down’s syndrome incorporating levels of pregnancy-associated plasma protein (PAPP-A) in women with pre-existing diabetes?

Why this is important

Several screening tests for Down’s syndrome incorporate measurements of PAPP-A. However, two clinical studies have reported conflicting results in terms of whether levels of PAPP-A in women with type 1 diabetes are lower than those in other women. Current practice is to adjust PAPP-A measurements in women with diabetes on the assumption that their PAPP-A levels are indeed lower than those of other women. Further research is, therefore, needed to evaluate the diagnostic accuracy and effect on pregnancy outcomes of screening tests for Down’s syndrome incorporating measurements of PAPP-A in women with pre-existing diabetes.

How effective is transvaginal ultrasound for the detection of congenital malformations in women with diabetes and coexisting obesity?

Why this is important

Obstetric ultrasound signals are attenuated by the woman’s abdominal wall fat. Many women with diabetes (and particularly women with type 2 diabetes) are obese, and this may limit the sensitivity of abdominal ultrasound screening for congenital malformations. Vaginal ultrasound does not have this difficulty, but there is currently no evidence that it is more effective than abdominal ultrasound. Research studies are, therefore, needed to evaluate the diagnostic accuracy and affect on pregnancy outcomes of vaginal ultrasound in women with diabetes and coexisting obesity. This is important because women with diabetes are at increased risk of having a baby with a congenital malformation.

Monitoring fetal growth and wellbeing

How can the fetus at risk of intrauterine death be identified in women with diabetes?

Why this is important

Unheralded intrauterine death remains a significant contributor to perinatal mortality in pregnancies complicated by diabetes. Conventional tests of fetal wellbeing (umbilical artery Doppler ultrasound, cardiotocography and other biophysical tests) have been shown to have poor sensitivity for predicting such events. Alternative approaches that include measurements of liquor erythropoietin and magnetic resonance imaging spectroscopy may be effective, but there is currently insufficient clinical evidence to evaluate them. Well-designed randomised controlled trials that are sufficiently powered are needed to determine whether these approaches are clinically and cost-effective.

Chapter 6 Intrapartum care

Analgesia and anaesthesia

What are the risks and benefits associated with analgesia and anaesthesia in women with diabetes?

Why this is important

The increasing number of women with diabetes and the high rate of intervention during birth emphasise the need for clinical studies to determine the most effective methods for analgesia and anaesthesia in this group of women. The research studies should investigate the effect of analgesia during labour, and the cardiovascular effects of spinal anaesthesia and vasopressors on diabetic control.

Glycaemic control during labour and birth

What is the optimal method for controlling glycaemia during labour and birth?

Why this is important

Epidemiological studies have shown that poor glycaemic control during labour and birth is associated with adverse neonatal outcomes (in particular, neonatal hypoglycaemia and respiratory distress). However, no randomised controlled trials have compared the effectiveness of intermittent subcutaneous insulin injections and/or CSII with that of intravenous dextrose plus insulin during labour and birth. The potential benefits of intermittent insulin injections and/or CSII over intravenous dextrose plus insulin during the intrapartum period include patient preference due to the psychological effect of the woman feeling in control of her diabetes and having increased mobility. Randomised controlled trials are therefore needed to evaluate the safety of intermittent insulin injections and/or CSII during labour and birth compared with that of intravenous dextrose plus insulin.

Chapter 7 Neonatal care

Prevention and assessment of neonatal hypoglycaemia

Is systematic banking of colostrum antenatally of any benefit in pregnancies complicated by diabetes?

Why this is important

Babies of women with diabetes are at increased risk of neonatal hypoglycaemia and may need frequent early feeding to establish and maintain normoglycaemia. Additionally, the opportunity for early skin-to-skin contact and initiation of breastfeeding is not always achieved in pregnancies complicated by diabetes because of the increased risk of neonatal complications requiring admission to intensive/special care. Antenatal expression and storage of colostrum may, therefore, be of benefit to babies of women with diabetes. There have been no clinical studies to evaluate the effectiveness of antenatal banking of colostrum in women with diabetes. Randomised controlled trials are needed to determine whether this practice is clinically and cost-effective. Encouraging women with diabetes to express and store colostrum before birth might be viewed as an additional barrier to breastfeeding in this group of women who already have lower breastfeeding rates than the general maternity population. There is also a putative risk of precipitating uterine contractions through antenatal expression of colostrum and an accompanying release of oxytocin. These factors should be explored in the randomised controlled trials.

Chapter 8 Postnatal care

Information and follow-up after birth

Are there suitable long-term pharmacological interventions to be recommended postnatally for women who have been diagnosed with gestational diabetes to prevent the onset of type 2 diabetes?

Why this is important

Oral hypoglycaemic agents such rosiglitazone and metformin offer the possibility of pharmacological treatment for prevention of progression to type 2 diabetes in women who have been diagnosed with gestational diabetes. As yet there have been no clinical studies to investigate the effectiveness of oral hypoglycaemic agents in this context. Randomised controlled trials are needed to determine the clinical and cost-effectiveness of such treatments compared with diet and exercise.

2.5. Algorithm

The algorithm for specific antenatal care for women with diabetes on the following four pages is reproduced from the Quick Reference Guide version of this guideline (revised July 2008).

Flowchart Icon

Antenatal care (PDF, 97K)

Footnotes

*

Level 2 critical care is defined as care for patients requiring detailed observation or intervention, including support for a single failing organ system or postoperative care and those ‘stepping down’ from higher levels of care.

**

Diabetes Control and Complications Trial (DCCT)-aligned haemoglobin A1c (HbA1c) test.

***

Metformin is used in UK clinical practice in the management of diabetes in pregnancy and lactation. There is strong evidence for its effectiveness and safety. This evidence is not currently reflected in the SPC (July 2008). The SPC advises that when a patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels. Informed consent on the use of metformin in these situations should be obtained and documented.

‘Type 2 diabetes: the management of type 2 diabetes’ (NICE clinical guideline 66), available from www​.nice.org.uk/CG066, updates the information on type 2 diabetes in this technology appraisal.

††

This recommendation is taken from ‘Antenatal care: routine care for the healthy pregnant woman’ (NICE clinical guideline 62), available from www​.nice.org.uk/CG062.

****

This recommendation is taken from ‘Antenatal care: routine care for the healthy pregnant woman’ (NICE clinical guideline 62), available from www​.nice.org.uk/CG062.

†††

Fasting plasma venous glucose concentration greater than or equal to 7.0 mmol/lite or 2 hour plasma venous glucose concentration greater than or equal to 7.8 mmol/litre. World Health Organization Department of Noncommunicable Disease Surveillance (1999) Definition, diagnosis and classification of diabetes mellitus and its complications. Report of a WHO consultation. Part 1: diagnosis and classification of diabetes mellitus. Geneva: World Health Organization.

Metformin is used in UK clinical practice in the management of diabetes in pregnancy and lactation. There is strong evidence for its effectiveness and safety. This evidence is not currently reflected in the SPC (July 2008). The SPC advises that when a patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels. Informed consent on the use of metformin in these situations should be obtained and documented.

§

Glibenclamide is used in UK clinical practice in the management of diabetes in pregnancy and lactation. There is strong evidence for its effectiveness and safety. This evidence is not currently reflected in the SPC (July 2008). The SPC advises that glibenclamide is contraindicated in pregnancy. Informed consent on the use of glibenclamide in pregnancy should be obtained and documented.

§§

For the purpose of this guidance, ‘disabling hypoglycaemia’ means the repeated and unpredicted occurrence of hypoglycaemia requiring third-party assistance that results in continuing anxiety about recurrence and is associated with significant adverse effect on quality of life

††††

Level 2 critical care is defined as care for patients requiring detailed observation or intervention, including support for a single failing organ system or postoperative care and those ‘stepping down’ from higher levels of care.

§§§

Metformin is used in UK clinical practice in the management of diabetes in pregnancy and lactation. There is strong evidence for its effectiveness and safety. This evidence is not currently reflected in the SPC (July 2008). The SPC advises that metformin is contraindicated in lactation. Informed consent on the use of metformin during lactation should be obtained and documented.

‡‡

Glibenclamide is used in UK clinical practice in the management of diabetes in pregnancy and lactation. There is strong evidence for its effectiveness and safety. This evidence is not currently reflected in the SPC (July 2008). The SPC advises that there is insufficient/limited information on the excretion of glibenclamide in human or animal breast milk. Informed consent on the use of glibenclamide during lactation should be obtained and documented.