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Michael C. Klein Centre Community Child Health Research Senior Scientist Emeritus Children and Family Research Institut

Canadian Association of Midwives November 1-3 2007 What’s not new in maternity care? “Hot topics in maternity care” It has been a very hot year with many cold moments. Michael C. Klein Centre Community Child Health Research Senior Scientist Emeritus Children and Family Research Institute

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Michael C. Klein Centre Community Child Health Research Senior Scientist Emeritus Children and Family Research Institut

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  1. Canadian Association of MidwivesNovember 1-3 2007What’s not new in maternity care?“Hot topics in maternity care”It has been a very hot year with many cold moments Michael C. Klein Centre Community Child Health Research Senior Scientist Emeritus Children and Family Research Institute Emeritus Professor of Family Practice and Pediatrics University of British Columbia Adjunct Professor of Family Medicine McGill University Faculty of Medicine

  2. My completely biased and idiosyncratic judgments about what is hot and what is not. • From where? MCDG discussions last year. • There are about 200 of the 600 members who are midwives. • About 200 postings on controversial topics related to evidence or EBM • I chose about 35 of which I will more or less seriously discuss X • To join the list send an email to mklein@interchange.ubc.ca

  3. “Hot” and Unfortunately Recycled Cold Topics • Complexity Theory as applied to maternity care—no magic bullet—induction discussion • The never-ending induction discussion • Ethics of cesarean section on maternal request—a feminist critique • The endless discussion of VBAC (GBAC) vs. elective CS • How many CS needed to prevent whatever pelvic floor outcome interests you? • Fallout from the NIH Conference on CS on Maternal Request • The ongoing epidural does it or doesn't it debate • Does NICE have the answer? • Home birth safety—enough already! Patti will talk about it • Can nurses change CS rate by engaging in early home support in person or by telephone? • More on Folic acid • Nitrous oxide and oxygen—why is it not more used?

  4. “Hot” and Unfortunately Recycled Cold Topics (2) • Obesity demographics—the year of blame the mother (more than usual) • 12 contractions in one hour is the “new” way to diagnose labour • Canada and especially USA loosing ground in maternal and perinatal statistics • Placentation problems increasing with each CS (previa, abruption, acreta, stillbirth, malpresentation, AP hemmorrhage, low birth weight, SGA, adhesions) • Series of new studies showing increased maternal and newborn morbidity and mortality with elective CS vs. planned vaginal birth • Fibroids not an indication for elective CS • Is isolated oligohydramnios in term pregnancy not an indication for induction? No! • OB residents not planning to offer vaginal breech—surprise surprise

  5. “Hot” and Unfortunately Recycled Cold Topics (3) • OK to eat fish; no its not. Biased manufacturer study • South Asians are too small; no they are not! Just need own growth charts • Water birth; encore une fois! Its safe already just let baby breath • Now a little alcohol is good for you! No its not! • Upright positions do indeed result in excess blood loss—but only if you have a perineal trauma • Group prenatal care results in equal or improved outcomes at no added costs—way to go South Health • Calcium at least 1 gram/day prevents pre-eclampsia • Hypertension in pregnancy associated mat CV disease • Serial antenatal corticosteroids to prevent prematurity OK for fetus (probably).

  6. Canada slipping among developed nations • In 1990Canada ranked 2nd in MMR • 6th in infant mortality • 12th PNMR • In 200711th MMR • 21st infant mortality • 14th PNMR • All at a time when our CS rates have risen dramatically, access is becoming an issue due to aging obstetrical workforce, family doctors departing and midwives just coming on stream—causality is hard to prove but the news is not good.

  7. VBAC 2007Spong CY et al Obstet Gynecol 110. • Prospective secondary analysis 39,117 women at 19 Centres • 15,323 TOL and 14,993 elective repeat • Overall rupture rate low at 3/1000 and low 2.7/1000 Hypoxic Ischemic Encephalopathy (HIE), stillbirth or neonatal death • Rupture Rates: • Indicated elective repeat CS 1.2 per 1000 • Elective repeat CS no indication 2 per 10,000 • CS with VBAC with labour 1.5 per 1000 • TOL 7.4 per 1000

  8. VBAC 2007(2) Spong CY et al Obstet Gynecol 110. • Adverse perinatal outcomes 1.3 to 4.0 per 1000 depending on mode of birth • 15 adverse perinatal outcomes • 12/15 cases of HIE in TOL • 3/15 cases of HIE in indicated elective CS • 0 in non-indicated elective CS • 8/15 adverse perinatal with ruptures • 7/15 after TOL • 1/15 with indicated elective repeat

  9. VBAC 2007(3) Spong CY et al Obstet Gynecol 110. • Maternal deaths by mode of birth • 6 maternal deaths but none with rupture • 5 of them with elective repeat CS • 3 amniotic fluid embolism • 1 hemorrhage • 1 anesthetic subdural • 1maternal death in TOL—hemorrhage • Again trading off maternal with fetal outcomes!

  10. Compare this with Gonen R et al Obstet and Gynecol 2006 • Israeli university unit devoted to caring for women with a uterine scar Jan 2000-May 2005 • For one scar only • 841 TOL and 467 elective CS • 1 rupture .841/1000 • 0 cases of significant neonatal problems NB new US data showed great variation between university larger units and smaller units, with better outcomes for the larger units. No comprehensive data for midwifery practice in Canadian autonomous model Note: today’s Obstet and Gynecol interpregnancy interval of less than 6 months increases risk of rupture 2.66x

  11. Not routine early inductions again! • Nicholson in July/August 2007 Annals of Family Practice presented his third study of “preventive induction • He developed a scoring system designed to pick up placentas that were becoming geriatric and fetus’ that were becoming to big and a few other risk factors • Most women get induced with prostin at 38 weeks • Gets a low CS rate about 5-10% similar to midwives • Fails to understand the Hawthorne effect—he and his disciples are the intervention not “preventive induction.” • They are caring physicians who are intimately involved with their patients • When they practice that way they get good results • If adopted by less caring and engaged docs, it will have the opposite effect • Stay tuned: the press loves it

  12. Norwegian replication of the Canadian Post-term trialHeimstad R et al Obs and Gynecol 2007 • Overall no differences in maternal or neonatal outcomes 580 women receiving prostaglandin inductions at 41 weeks vs. expectant management (used more amniotomy or oxy in Hannah Trial) • No differencesin low 5 min Apgars or low cord pH or • or Asphyxia or NICU admissions • or Meconium aspiration • or Neonatal/Perinatal death (1 true cord knot) • More ppt labours in induction group and more oligo in expectant group without apparent serious consequences • CS 11 vs. 12% much lower than Hannah Trial • Instrumental 13 vs. 11%

  13. The Ongoing Epidural Discussion • New metaanalysis from Anesthesiology claiming that even early epidurals do not raise the CS rate. • NICE from the UK has a recent policy on intrapartum care that also says that epidural do not raise the CS rate. • All available studies take place in environments with low CS rates in the range of 10% where women are cared for by nurse midwives and OBs function exclusively as consultants • Internally valid but has no external validity for settings with 30% CS rate and where nurse midwives do not manage/support normal birth • In such low CS settings epidurals are used selectively and not routinely • Epidural so applied can resolve problems and may even help to keep the CS section low.

  14. Can nurses change CS rate by engaging in early home support in person or by telephone? • ELASH study Patti Janssen et al Published in Obstet and Gynecolgy • Nulliparous women randomized in several BC sites to receive nursing telephone triage and advice and home visits as possible and needed vs. usual care • Minimal but statistically significant later arrival at hospital but no difference in CS rate • Once in the system and usually entered at 3-4 cms too late to change much • The industrialized fear-based system of care took over • Small intervention. Midwifery care is a big intervention that keeps women out of hospital much longer.

  15. More data multiple sources on maternal consequences of elective CS: • Surgical mortality/morbidity • Cesarean vs vaginal birth • 156 CS 1 extra readmission • 444 CS 1 extra abruption • 489 CS 1 extra ectopic • 230 CS 1 extra placenta previa • 694 CS 1 extra invasive placenta • 2667 CS 1 extra hysterectomy • Poorer outcomes in subsequent births for baby—increase stillbirth, prematurity and low birth weight

  16. Previa, Abruption and Stillbirth by Parity in Women with a Scar • Yang Q et al BJOG 2007 and Grey R et al 2007 • Previa in 4.4 per 1000 2nd births vs. 2.7 per 1000 for women whose 2nd births vaginal • Abruption 6.6 vs 4.8 per 1000 scar vs. vaginal 2nd births • Stillbirth hazard ratio second birth with scar 1.54 (CI 1.04-2.09)

  17. Adverse Perinatal Outcomes 2nd birth with a scar from Australia • Kennare R. Obstetrics and Gynecol 2007 • Malpresentation OR 1.84 (CI 1.65-2.06) • Previa OR 1.66 (CI 1.30-2.11) • APH OR 1.23 (CI 1.08-1.41) • Accreta OR 18.79 (2.28-864.6) • Stillbirth OR 1.56 (CI 1.04-2.32) • Unexplained stillbirth OR 2.34 (CI 1.26-4.37) • Yet ACOG Practice Bulletin Nov 1, 2007 states women who are planning “several” births ONLY should avoid the first CS!!

  18. Ongoing evidence multiple sources of: • Newborn consequences that favor CS • Cesarean vs vaginal birth • 22,641 CS prevent 1 subdural/intracranial bleed • 19,601 CS prevent 1 IVH • 7,549 CS prevent 1 subarachnoid hemorrhage • 10,613 CS prevent 1 neonatal convulsion • 5,666 CS prevent 1 newborn CNS depression • 2,164 CS prevent 1 brachial plexus injury

  19. Ongoing evidence multiple sources of: • Newborn consequences favoring vaginal birth • Cesarean vs vaginal birth • 338 CS 1 extra severe feeding difficulty • 69 CS 1 extra respiratory problem • 80 CS 1 extra TTN • 129 CS 1 extra RDS • 247 CS 1 extra pneumonia • 162 CS 1 extra level III admission • 153 CS 1 extra 5 min Apgar less than 7 • 317 CS 1 extra newborn on respirator for more than 24 hours

  20. Problem! • Problems with all these studies is that most have difficulty separating elective from non-elective cesarean sections • Ideal study would compare women planning vaginal birth, regardless of outcome with those planning non-indicated cesarean sections. Does not exist! • An RCT impossible! What kind of woman would not care what type birth she would have?

  21. Hospital-basedresearch from Latin America: Maternal/newborn Cesarean vs vaginal birth • WHO study from all of Latin America Villar J et al Lancet 2006 and October 30 2007 BMJ 97,095 births with CS rate of 33% in 120 institutions in 8 countries found that hospitals with the highest CS rate had highest rates of maternal death and illness and highest rates of neonatal death and ICU admission. • This study is being replicated for all of Canada under a WHO/CIHR grant

  22. Latin American Study in detail: • Neonatal Morbidity/Mortality CS vs. Vaginal Birth • Increased neonatal stay: • OR 2.1 (CI 1.8-2.6) for intrapartum CS • Elective CS 1.9 (CI 1.6-2.3) • Neonatal death: • OR 1.7 (CI 1.3-2.2) Intrapartum CS • Elective CS OR 1.9 (CI 1.5-2.6) • 3 per 1000 SVD • 6.1 per 1000 intrapartum CS • 8.0 per 1000 elective CS

  23. Latin American Study in detail: • Neonatal Morbidity/Mortality CS vs. Vaginal Birth • Increased neonatal stay OR 2.1 (CI 1.8-2.6) CS • Elective CS 1.9 (CI 1.6-2.3) • Neonatal death OR 1.7 (CI 1.3-2.2) Intrapartum CS • Elective CS OR 1.9 CI 1.5-2.6) • 3 per 1000 SVD • 6.1 per 1000 intrapartum CS • 8.0 per 1000 elective CS

  24. French study: Hospital-based maternal outcomes CS vs. Vaginal Birth: • Deneux-Tharaux et al Obstet and Gynecol 2006; 108:541-8 • 10,244 women: after adjustment for confounders and removal of women hospitalized before delivery, risk peripartum maternal death 3.6x higher after CS vs vaginal birth (mostly anaesthsia, infection & venous thromboembolism).

  25. New US study maternal morbidity and rehospitalizationCesarean vs. vaginal birth Declercq et al. in Obstetrics and Gynecology March 2007 • Rehospitalizations 19 per 1000 CS vs 7.5 per 1000 vaginal • Leading cause of rehospitalizations was wound infections/complications: 6.6 CS vs : 3.3 per 1000 for vaginal births

  26. Newborn consequencesNew US data Cesarean vs vaginal birthMacDorman et al BIRTH Sept 2006 • 1998-2001 research on neonatal mortality vaginal vs. planned or elective CS—after controlling for indications for elective CS (truly no indication CS) • Based on 5,762,037 live births and 11,890 deaths • 0.62 neonatal deaths per 1000 vaginal vs 1.77 per 1000 CS • Employing Odds ratios--roughly twice the neonatal death rate for CS @1/1000 vaginal and 2/1000 CS, after controlling for CS indications

  27. Best to date is Canadian! New Canadian study of maternal mortality and severe morbidity Elective cesarean vs planned vaginal birth • First study truly planned vaginal birth vs. planned cesarean delivery (breech surrogate) Liu, Liston Kramer etc CMAJ Feb 13, 2007 pgs 455-60 • 46,766 elective breech vs. 2,292,420 planned vaginal • After adjustment for confounders to make low risk in both groups • Planned CS had more cardiac arrests x5, hysterectomy x3.2, infection x3, thromboembolism x2.2, hemorrhage requiring hysterectomy x2.1, anesthetic complications x2.3

  28. New Canadian data on neonatal outcomes by mode of birth • Nova Scotia all births 1988-2002 BMJ Fiona Liston Archives Dis Child Fetal edition Oct 2007 • 142,971 births CS rate ~21% those years • CS mostly repeats (62%), breech (21%) • Adverse neonatal outcomes low about 1% all comers • 3x low 5 min Apgars in CS vs. spontaneous vaginal but no difference HIE with no labour (elective) CS vs. spontaneous vaginal • CS newborns 5.4x more likely to experience RDS and 2.4x more TTN than newborns delivered vaginal spontaneously • NICU stays for newborn >24 hours greatest for CS no matter if elective or in labour.

  29. New Canadian data on neonatal outcomes by mode of birth (Liston cont) • Major neonatal trauma: • SVD 3/1000 • Instrumental births 14/1000 • CS in labour 2/1000 • Elective CS 1/1000 • TTN: • SVD 6/1000 • Elective CS 16/1000 • NICU >24 hours: • SVD 22/1000 • Instrumental 36/1000 • CS in labour 52/1000 • Elective CS 44/1000 • Small problem may be the long duration of study from 1988 to 2002 leading to excess instrumental trauma and perhaps not enough cesarean data from later years favoring cesarean outcomes from eras when less were done

  30. Urinary Incontinence (UI) structured review literature Press, Klein et al BIRTH Sept 2007 • 10.4 CS compared to VB to prevent one case of unspecified short-term UI - After removing instrumental births: 11.6 CS to prevent one case of short-term UI • 109 CS to prevent one case of short-term urge incontinence • 14.6 CS compared to VB to prevent one case of short term Stress UI • After removing instrumental births 16 CS to prevent 1 case of short term Stress UI No difference for severe UI even short term by mode of delivery

  31. Fecal Incontinence • When we combined 13 studies of any level of FI: • CS compared to VB: to prevent one case of short term fecal incontinence need to do 32 CS • But after removing instrumental births NNT increased to 49 CS • Many more for long-term FI

  32. Sexual Dysfunction • 11 CS compared to VB to prevent one case of short term sexual dysfunction • After removing instrumental births 14 CS to prevent one case of short-term sexual dysfunction • 10 CS compared to VB to prevent one case of short term sexual dissatisfaction • No difference for sexual desire, frequency of intercourse, or sense of sexual attractiveness by mode of delivery BUT, after 6 months postpartum, no sexual differences by mode of birth.

  33. Conclusion (1) Newborn Outcomes by mode of Birth • There are slight short term benefits to the baby for delivery by elective CS in trauma reduction • But this is at expense of longer NICU stays for RDS and TTN—with more parental separations • And more placentation-related perinatal complications, even stillbirth in subsequent pregnancies for a policy of allowing, even encouraging CS on request.

  34. Conclusion (2) Maternal Outcomes by mode of Birth • Elective CS is clearly more dangerous for the mother than planned vaginal birth • Mothers are being placed in an impossible position. • For marginal, principally short-term benefits to the fetus in the first pregnancy, and for high NNTs for benefits for her pelvic floor, she is being encouraged to expose herself to additional personal risks for herself in the present and for herself and her fetus in subsequent pregnancies. • Some choice!

  35. Inadvertently Term Breech Trial provided natural experiment addressing both maternal and newborn consequences of mode of birth: • While early for the newborn and at 3 months, the study showed urinary and sexual benefit to CS for breech compared with vaginal birth • At 2 years postpartum NO DIFFERENCE baby or pelvic floor • And vaginal breech birth harder on pelvic floor and perhaps baby • Study demonstrates resilience and self-healing capacity of the pelvic floor and resilience of the newborn as well.

  36. NIH Conference “Cesarean Delivery on so-called Maternal Request • No data about maternal request: why a conference? • Inappropriate comparison groups (used Term-Breech as surrogate for vaginal vertex births). • Failed to study subsequent pregnancies (previas, accretas, abruptions, ectopics, infertility etc) • Employed large retrospective cohort studies of all births of variable quality vs CS of higher quality • Did not compare best/physiologic birth practices with CS • Recommendations made no senseeg recommended no CS only for women planning “several” births when data suggests “more than one” • Opened the door to CS on request—since not enough data on vaginal vs CS in comparable groups—reason to accept CS on request? • Accepted pathological model of birth (birth is nothing more than an opportunity for side effects or adverse outcomes) • No mention of powerful and transformative nature of vaginal birth

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