Royal College of Obstetricians and Gynaecologists

1. Setting standards to improve women’s health Royal College ofObstetricians andGynaecologists • Risk Management and Medico-Legal Issues In Women’s Health • Joint RCOG/ENTER Meeting • Please turn off all mobile phones and pagers

2. How can we reduce stillbirth rates in diabetic pregnancies? Jo Modder CEMACH Clinical Director (Obstetrics) Consultant Obstetrician UCLH NHS Trust

3. What is a diabetic pregnancy? • Pregnancy in a woman with pre-existing diabetes • Either type 1 or type 2 diabetes that had been diagnosed at least 1 year before the woman’s estimated delivery date (EDD) CEMACH 2005

4. What is the stillbirth rate in diabetic pregnancies? Type 1 diabetes Type 2 diabetes 32.3 35 31.7 29.2 England, Wales & Northern Ireland (2002) 30 25.8 25 20 15 8.5 9.6 9.5 10 5.7 3.6 5 0 Stillbirth rate* PNMR* Neonatal death rate** *per 1000 total births **per 1000 live births † Source: Confidential Enquiry into Maternal and Child Health: Pregnancy in women with type 1 and type 2 diabetes in 2002-03, England, Wales and Northern Ireland. CEMACH: London; 2005.

5. Possible mechanisms for stillbirth ↑ fetal blood glucose ↑ fetal insulin ↑ maternal blood glucose ↑O2 Consumption ↓ O2 release from RBC ↑ fetal basal metabolic rate Fetal hypoxia

6. Fetal polycythaemia Fetal thrombosis ↑ maternal blood glucose ↑ lactate ↓fetal pO2 ↓fetal pH

7. Current interventions to reduce stillbirth rate • Good glycaemic control • Early booking • Frequent antenatal visits • Multidisciplinary team • Fetal surveillance • Frequent ultrasound scans • Delivery between 38 – 40 weeks

8. The CEMACH national enquiry • National survey of diabetes maternity services • Descriptive study of 3808 pregnancies to women with diabetes • Panel enquiry into 442 + 79 additional type 2 pregnancies • Audit of care • What factors associated with poor pregnancy outcome? • Comparison of type 1 and type 2 diabetes

9. Causes of stillbirth and neonatal death

10. Pregnancies in the enquiry (n=442) Cases • All 127 offspring with congenital anomaly • All95 normally-formed deaths from 20 weeks Controls • Random sample of 220 controls

11. Contribution of stillbirths to normally-formed deaths from 20 weeks gestation

12. What factors are associated with deaths of normally-formed babies from 20 weeks’ gestation?

13. Maternal factors associated with fetal death from 20 weeks *Odds ratio is for unit increase in deprivation quintile † adjusted for maternal age and social deprivation

14. Social and lifestyle factors associated with death from 20 weeks * Adjusted for maternal age and social deprivation

15. Issues identified by panels underlying suboptimal glycaemic control and suboptimal approach of the woman • Non attendance at planned appointments • Non-adherence to medical advice • Lifestyle issues • difficulties with English, domestic circumstances, erratic or busy lifestyles • Unplanned pregnancy • Poor motivation • Poor education/understanding of diabetes

16. Did women have a discussion with a health professional in the 1 year before pregnancy?

17. Was good preconception care provided? • 73% of 267 women in the enquiry had suboptimal preconception care • Issues identified by panels: • Opportunity not taken by health professional to give preconception advice • Folic acid not advised or prescribed by health professionals

18. Fetal factors associated with death from 20 weeks * Adjusted for maternal age and social deprivation

19. Association of suboptimal antenatal fetal surveillance with death from 20 weeks a Adjusted for maternal age and social deprivation † Evidence of fetal size >90th centile

20. Issues underlying suboptimal fetal monitoring for big babies (n=58) • Lack of timely follow-up • Poor interpretation of ultrasound scans • Incorrect actions taken as a response to tests

21. Maternity care factors associated with death from 20 weeks a Adjusted for maternal age and social deprivation † for women who delivered from 24+0 weeks only

22. Issues identified by panels underlying suboptimal maternity care in the antenatal period • Suboptimal fetal surveillance • Poor management of maternal risks • Problems with the multidisciplinary team • Need for more senior obstetrician input • Poor communication between health professionals • Inappropriate mode and/or timing of delivery

23. Discussion of mode and timing of delivery • Median 35 weeks (range 5 – 40 weeks) • Women who did not have a discussion delivered earlier than those who had a discussion (median gestation at delivery 35 versus 37 weeks).

24. Current interventions to reduce stillbirth rate • Good glycaemic control • Early booking • Frequent antenatal visits • Multidisciplinary team • Fetal surveillance • Frequent ultrasound scans • Delivery between 38 – 40 weeks

25. Could we reduce the stillbirth rate further by: • Consistent provision of consistent preconception care? • Folic acid • Contraception • Glycaemic control • Education of health professionals

26. Could we reduce the stillbirth rate further by: • Consistent provision of maternity care? • Careful antenatal fetal surveillance • Identification and management of maternal risk factors • Senior obstetrician input into management • Effective diabetes antenatal multidisciplinary team • Good communication?

27. Questions to be answered • How can we improve the provision and uptake of preconception care in the UK? • What test/s can be used to predict the fetus of a woman with diabetes who is at risk of intrauterine death? • At what gestation should babies of diabetic mothers be delivered?

28. CEMACH recommendations • NICE Diabetes in Pregnancy guideline

29. Thank youwww.cemach.org.uk

30. Setting standards to improve women’s health Royal College ofObstetricians andGynaecologists • Risk Management and Medico-Legal Issues In Women’s Health • Joint RCOG/ENTER Meeting • Please turn off all mobile phones and pagers

31. A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL COMPARING THE EFFICACY OF INTRAMUSCULAR SYNTOMETRINE AND INTRAVENOUS SYNTOCINON, IN PREVENTING POST PARTUM HAEMORRHAGE Mohammed Rashid, Medical Student, Imperial College Dr Mumtaz, Consultant O&G, James Paget Hospital, Norfolk Abstract Presentation Risk Management Conference April 2008

32. Introduction • Post partum haemorrhage (PPH) remains the leading cause of maternal death in the developing world, accounting for 25-33% of all maternal deaths1 • The most common cause of PPH is uterine atony2 • Prevention of PPH is of great importance in the pursuit of improved health care for women, even more so in developing countries where parity, and therefore the risk of uterine atony, is higher

33. Existing Knowledge • Routine prophylactic administration of an oxytocic during the third stage of labour reduces the risk of PPH by 40%3 • In the UK and Ireland, intramuscular syntometrine is most commonly used, while in the rest of Europe, the USA and Canada, syntocinon is most commonly used4 • But which is better? • This study is the first randomised controlled trial comparing intramuscular syntometrine and intravenous syntocinon in a population group that included high risk women.

34. Method • Study done in a high risk population in the Gulf • Patients who were seen in the obstetric clinic at 36 weeks of gestation were invited to participate in the trial • Strict inclusion/exclusion criteria • 686 patients were randomly allocated to receive either one vial of intramuscular syntometrine or 10 units of intravenous syntocinon • Each patient received their allocated drug with the delivery of the anterior shoulder of the baby

35. Outcome measures • The primary outcome measure was the amount of blood loss during delivery • Secondary outcome measures included other indicators of blood loss and possible side effects

36. Quick look at demographics • 340 women received intramuscular syntometrine and 346 women received intravenous syntocinon • 37% of maternities were para four or above, 27% were para five or above, 16% were para six or above and the highest parity was thirteen.

37. Results • Primary outcome measure • * The size of the estimated difference is the difference in means for the continuous outcomes and the relative risk for the binary outcomes

38. Results Secondary outcome measures • There was an increase in the incidence of having a diastolic blood pressure of between 90 and 100, thirty minutes after the delivery (p=0.004), with intramuscular syntometrine

39. Discussion • In higher parity women, the myometrium is gradually replaced by more and more fibrous tissue. Syntocinon contracts the myometrium, but has little effect on fibrous tissue thus theoretically making it less effective in such women, however this was not supported by our study • The superior effect of intravenous syntocinon compared its intramuscular counterpart may be related to the earlier onset of action expected when using an intravenous administration

40. Discussion continued • The increased incidence of having diastolic hypertension was demonstrated (>90 mm Hg thirty minutes after delivery) in the syntometrine group, was supported by findings in other studies5,6 and is thought to be due to the vasoconstriction effect of syntometrine

41. Strengths and Weaknesses • The researchers, the patients and the midwives were blinded • Midwives were carefully instructed on how to properly measure blood loss • Every measurement was repeated • Visual estimation of blood loss is known to be inaccurate

42. Conclusion • Intramuscular syntometrine and intravenous syntocinon are equally effective in preventing postpartum haemorrhage, in a high risk population. There is an increased risk of diastolic hypertension after the delivery with intramuscular syntometrine.

43. References • Duffy S. Global perspective Obstetric haemorrhage in Gimbie, Ethiopia. TOG 2007;9:121-126. • Lewis, G. The Confidential Enquiry into Maternal and Child Health (CEMACH) ‘Saving mother’s lives: Reviewing maternal deaths to make motherhood safer’-2003-2005. The seventh report on Confidential Enquiry into Maternal Deaths in the United Kingdom. 2007, London. CEMACH. • Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management in the third stage of labour. Cochrane Database Syst Rev 2003:CD000007. • Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG 2007;114(7) :845-54. • Choy CMY, Lau WC, Tam WH, Yuen PM. A Randomised controlled trial of intramuscular syntometrine and intravenous oxytocin in the management of the third stage of labour. BJOG 2002;109 (2):173-177. • Khan G Q, John I S, Chan T, Wani S, Hughes A O, Stirrat G M. Abu Dhabi third stage trial: oxytocin versus Syntometrine in the active management of the third stage of labour. Eur J Obstet Gynecol Reprod Biol 1995; 58(2):147-51.

44. Questions & Answers Thank you for listening

45. Flowchart

46. Recruitment Statistics

47. Characteristics of the study population Values are shown as mean (standard deviation) or n (%)

48. Primary outcome measures • * The size of the estimated difference is the difference in means for the continuous outcomes and the relative risk for the binary outcomes

49. Sub-group analysis of blood loss during delivery by parity

50. Other indicators of blood loss