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PVL_COUNTRY_DATE00/1 Département santé et recherche génésiques Department of reproductive health and research a y 3 - S e s s i o n 2 DAY (3) DAY (3) Session 2 Session 2 Presentation: Prophylactic Presentation: Prophylactic corticosteroids for preterm birth corticosteroids for preterm birth

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PVL_COUNTRY_DATE00/3 Département santé et recherche génésiquesDepartment of reproductive health and research Day 3 - Session 2 Prophylactic corticosteroids for preterm birth It is August It is August You are a keen young midwife caring for a patient who has just been admitted in premature labour. You are a keen young midwife caring for a patient who has just been admitted in premature labour. Your patient is 30 weeks pregnant. Your patient is 30 weeks pregnant.

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Page 1: PVL_COUNTRY_DATE00/1 Département santé et recherche génésiquesDepartment of reproductive health and research Day 3 - Session 2 DAY (3) Session 2 Presentation:

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Presentation: Prophylactic corticosteroids for Presentation: Prophylactic corticosteroids for preterm birthpreterm birth

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Learning objectivesLearning objectives

• To recognise the dangers of reading a report To recognise the dangers of reading a report without looking at all available evidence.without looking at all available evidence.

• To learn the importance of critical appraisal To learn the importance of critical appraisal (of a systematic review).(of a systematic review).

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Prophylactic corticosteroids for Prophylactic corticosteroids for preterm birthpreterm birth

• It is August 1982.It is August 1982.• You are a keen young midwife caring for a You are a keen young midwife caring for a

patient who has just been admitted in patient who has just been admitted in premature labour.premature labour.

• Your patient is 30 weeks pregnant.Your patient is 30 weeks pregnant.

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Prophylactic corticosteroids for Prophylactic corticosteroids for preterm birthpreterm birth

• You wonder whether corticosteroids are You wonder whether corticosteroids are indicated for the prevention of respiratory indicated for the prevention of respiratory distress syndrome in the baby.distress syndrome in the baby.

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Steps in EBRHCSteps in EBRHC

• Asking the questionAsking the question• Searching for the answerSearching for the answer• Finding the evidenceFinding the evidence• Interpreting the evidenceInterpreting the evidence

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ExerciseExercise

• Take 5 minutes to compose a three-part Take 5 minutes to compose a three-part clinical question that would help you to find clinical question that would help you to find the necessary evidence.the necessary evidence.

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Searching for the answerSearching for the answer

• Would you:Would you:– visit the local medical library?visit the local medical library?– do a computer search?do a computer search?– consult an expert (your consultant)?consult an expert (your consultant)?

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Searching for the answerSearching for the answer

• look for an answer in look for an answer in – textbooks?textbooks?– practice guidelines?practice guidelines?– RCTs?RCTs?– systematic reviews?systematic reviews?

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““MEDLINE” citationMEDLINE” citation

• Liggins GC, Howie RNLiggins GC, Howie RN. A controlled trial of . A controlled trial of antepartum glucocorticoid treatment for antepartum glucocorticoid treatment for prevention of the respiratory distress prevention of the respiratory distress syndrome in premature infants. syndrome in premature infants. Pediatrics,Pediatrics, 1972;50:515-525. 1972;50:515-525.

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A later citation:A later citation:

• Block MF, Kling OR, Crosby WM. Antenatal Block MF, Kling OR, Crosby WM. Antenatal glucocorticoid therapy for the prevention of glucocorticoid therapy for the prevention of respiratory distress syndrome in the respiratory distress syndrome in the premature infant. premature infant. Obstet Gynecol,Obstet Gynecol, 1977;50:186-90.1977;50:186-90.

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A more recent citation:A more recent citation:

• published in the BMJ as a “Leading article”published in the BMJ as a “Leading article” • Robertson NR. Advances in respiratory Robertson NR. Advances in respiratory

distress syndrome. distress syndrome. British Medical Journal, British Medical Journal, 1982;284:917-918 1982;284:917-918

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What would you do?What would you do?

• Work through the trials and try to synthesise Work through the trials and try to synthesise a summary of their results?a summary of their results?

• Read the above-mentioned article in the Read the above-mentioned article in the BMJ?BMJ?

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BMJ 1982 article conclusionBMJ 1982 article conclusion

• ““The evidence suggests that antenatal steroids are The evidence suggests that antenatal steroids are of value only in white males, and even for them the of value only in white males, and even for them the benefit is mainly in those of 30–32 weeks’ benefit is mainly in those of 30–32 weeks’ gestation, when in our experience serious morbidity gestation, when in our experience serious morbidity and mortality from respiratory distress syndrome is and mortality from respiratory distress syndrome is rare. In black males and in girls treatment has not rare. In black males and in girls treatment has not been proven to be of benefit.”been proven to be of benefit.”

Robertson NR. Advances in respiratory distress Robertson NR. Advances in respiratory distress syndrome. syndrome. British Medical Journal, British Medical Journal, 1982;284:917-9181982;284:917-918

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Exercise:Exercise:

• Take 20 minutes to study the table titled: Take 20 minutes to study the table titled: “Results of the trials done pre-1980” which is “Results of the trials done pre-1980” which is printed in your manuals and to answer the printed in your manuals and to answer the questions which are printed below the table.questions which are printed below the table.

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Results of early trials published Results of early trials published before 1980before 1980

TrialTrial N N Odds Ratio Odds Ratio CI CIa 1972a 1972 10701070 0.55 0.55 0.38 - 0.800.38 - 0.80b 1977b 1977 130 130 0.32 0.32 0.11 - 0.970.11 - 0.97c 1978c 1978 126 126 0.32 0.32 0.11 - 0.890.11 - 0.89d 1979d 1979 127 127 0.58 0.58 0.22 - 1.560.22 - 1.56e 1979 e 1979 146 146 0.25 0.25 0.10 - 0.620.10 - 0.62

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Systematic reviewSystematic review

• Crowley P, Chalmers I, Keirse MJNC. The Crowley P, Chalmers I, Keirse MJNC. The effects of corticosteroid administration before effects of corticosteroid administration before preterm delivery: an overview of the preterm delivery: an overview of the evidence from controlled trials. evidence from controlled trials. British British Journal of Obstetrics and GynaecologyJournal of Obstetrics and Gynaecology 1990;97:11-25. 1990;97:11-25.

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Results of systematic reviewResults of systematic review

• The occurrence of neonatal respiratory The occurrence of neonatal respiratory distress is the principal outcome reported in distress is the principal outcome reported in the 12 eligible trials identified. Antenatal the 12 eligible trials identified. Antenatal corticosteroid administration is associated corticosteroid administration is associated with an overall reduction of about 50% in the with an overall reduction of about 50% in the odds of this form of neonatal morbidity odds of this form of neonatal morbidity (typical odds ratio 0.49, 95% CI 0.41-0.60)(typical odds ratio 0.49, 95% CI 0.41-0.60)

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Cochrane systematic review: Main Cochrane systematic review: Main resultsresults

• Antenatal administration of corticosteroids Antenatal administration of corticosteroids (individual doses given in review) to women (individual doses given in review) to women expected to give birth preterm was expected to give birth preterm was associated with a significant reduction in associated with a significant reduction in respiratory distress syndrome (odds ratio respiratory distress syndrome (odds ratio 0.53, 95% confidence interval 0.44 to 0.63) 0.53, 95% confidence interval 0.44 to 0.63) in preterm infants. in preterm infants.

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Cochrane systematic reviewCochrane systematic review

• ““Despite repeated randomised trials Despite repeated randomised trials throughout the 1970s and 1980s and a throughout the 1970s and 1980s and a systematic review of randomised trials in systematic review of randomised trials in 1987 providing incontrovertible evidence in 1987 providing incontrovertible evidence in favour of antenatal corticosteroid therapy, favour of antenatal corticosteroid therapy, obstetricians all over the world have been obstetricians all over the world have been slow to adopt this treatment.”slow to adopt this treatment.”Crowley P, author of the Cochrane review Crowley P, author of the Cochrane review

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Cochrane review (continued)Cochrane review (continued)

• ““The causes of this reluctance are unclear. A The causes of this reluctance are unclear. A possible explanation is that the use of possible explanation is that the use of antenatal corticosteroids has not been antenatal corticosteroids has not been promoted by any pharmaceutical company. promoted by any pharmaceutical company.

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Cochrane SR (continued)Cochrane SR (continued)

• Obstetricians may have been influenced by Obstetricians may have been influenced by informal reviews that suggested that informal reviews that suggested that corticosteroids are effective only in certain corticosteroids are effective only in certain small sub-groups of women and babies.”small sub-groups of women and babies.”