Conflict of Interest - UAB ... Intrapartum monitoring Continuous Intrapartum FHR Monitoring Cesarean

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  • Obstetrics on the Cutting Edge: Research Information on the

    Progress in OBGYN 2015Progress in OBGYN 2015

    Horizon

    Alan T. N. Tita, MD, PhDAlan T. N. Tita, MD, PhD Professor Professor

    University of Alabama at BirminghamUniversity of Alabama at Birmingham

    Conflict of Interest ●PI for some these studies

    Objective ● Briefly review research that will likely

    influence obstetric practice including: – Selected UAB / MFMU Network research

    – Other recently completed research

  • NICHD MFMU Network

    • Columbia  • Case Western • Colorado • Northwestern  • Ohio State  • Duke  • U AlabamaU Alabama • U North Carolina • U Texas‐Houston • U Texas SW‐Dallas • U Utah • U TMB Galveston • Stanford U • Brown U

    CESAREAN SECTION OPTIMAL CESAREAN SECTION OPTIMAL ANTIBIOTIC PROPHYLAXISANTIBIOTIC PROPHYLAXIS

    (C/SOAP) TRIAL(C/SOAP) TRIAL

    HypothesesHypotheses

    ExtendedExtended--spectrum prophylaxis spectrum prophylaxis (with (with azithromycinazithromycin)) compared to compared to cefazolincefazolin alone reduces risk ofalone reduces risk ofcefazolincefazolin alone reduces risk of alone reduces risk of

    1.1. PostPost--cesarean infectioncesarean infection 2.2. Neonatal morbidityNeonatal morbidity

  • Antibiotic ProphylaxisAntibiotic Prophylaxis

     ↓Infectious morbidity: ↓Infectious morbidity: 50%50%  CostCost--effectiveeffective CostCost--effectiveeffective

    MugfordMugford: BMJ, 1989: BMJ, 1989 SmaillSmaill: Cochrane, 2013: Cochrane, 2013 ChelmowChelmow: AJOG, 2004: AJOG, 2004

    Unscheduled cesareans: Unscheduled cesareans: Standard preStandard pre--incision incision cefazolincefazolin

    FollowFollow--upup Puerperal InfectionPuerperal Infection

    Di hDi h 5%5%DischargeDischarge 5%5%

    6 weeks PP6 weeks PP 77--12%12%

    Extended ProphylaxisExtended Prophylaxis

    cefazolincefazolin ++

    22ndnd AntibioticAntibiotic22ndnd AntibioticAntibiotic •• AzithromycinAzithromycin

    •• MetronidazolMetronidazol

  • Why Why AzithromycinAzithromycin?? Covers additional organismsCovers additional organisms

    •• UreaplasmaUreaplasma sp. ++sp. ++

    •• Most common organisms in Most common organisms in postpost--cesarean infectionscesarean infections

    ExtendedExtended--spectrum Prophylaxis:spectrum Prophylaxis:

     ↓Total infection↓Total infection

     ↓Hospital stay↓Hospital stay

    –– ↓ Costs ↓ Costs

    Andrews: Andrews: O&G, 2003O&G, 2003 N=597N=597

    17% 19%

    25% 28%

    15

    20

    25

    30

    35

    Pe rc

    en t

    Extended Standard

    0.8%

    17%

    3.6% 0

    5

    10

    15

    Endometritis Wound Infections Endometritis or Wound Infection

    P Standard

  • Tita: Tita: O&GO&G, 2008, 2008

    15

    20

    25

    30

    m et

    rit is

    (% )

    Narrow spectrum prophylaxis

    Routine extended prophylaxis

    Trial of extended spectrum prophylaxis

    23%

    16%

    2.1%

    0

    5

    10

    19 92

    19 93

    19 94

    19 95

    19 96

    19 97

    19 98

    19 99

    20 00

    20 01

    20 02

    20 03

    20 04

    20 05

    20 06

    Year

    En do

    m

    Extended Prophylaxis: Extended Prophylaxis: ConcernsConcerns

     GeneralizabilityGeneralizability (1 center)(1 center)  No data on preNo data on pre--incision useincision usepp

    –– BenefitsBenefits –– Neonatal exposureNeonatal exposure

     CostCost--effectivenesseffectiveness

    C/SOAP (N=2000)C/SOAP (N=2000)

    NonNon--elective cesareanelective cesarean

    RCTRCT

    ExclusionsExclusions

    RCTRCT (Routine cefazolin for all)(Routine cefazolin for all)

    AzithromycinAzithromycin PlaceboPlacebo

  • C/SOAP TrialC/SOAP Trial  OutcomesOutcomes Postpartum infection (6 weeks)Postpartum infection (6 weeks) Neonatal/infant morbidity (3 months)Neonatal/infant morbidity (3 months)

     StatusStatus ●● N=2013 enrolled (13 sites)N=2013 enrolled (13 sites) ●● Completing followCompleting follow--upup ●● Results within the next yearResults within the next year

    Antenatal Late Preterm Steroids Antenatal Late Preterm Steroids (ALPS) RCT(ALPS) RCT

    Primary Research Question Primary Research Question -- ALPSALPS

    ●● In patients with an anticipated In patients with an anticipated late late PTBPTB –– Not previously received a steroids Not previously received a steroids

    ●● Does antenatal corticosteroids reduce risk ofDoes antenatal corticosteroids reduce risk of●● Does antenatal corticosteroids reduce risk of Does antenatal corticosteroids reduce risk of respiratory and other neonatal morbidity? respiratory and other neonatal morbidity?

  • Late Preterm Healthcare BurdenLate Preterm Healthcare Burden Discharge Delays: 42% LP vs. 5% at termDischarge Delays: 42% LP vs. 5% at term

    10

    20 30

    40

    50

    60

    Full term Late preterm

    Mean difference in the cost of care for a LP infant: $ 3877Mean difference in the cost of care for a LP infant: $ 3877 US projections based on 9.1% LP rate: US projections based on 9.1% LP rate: $1.4 $1.4 billionbillion dollarsdollars

    Wang et al, Pediatr 114:372, 2004

    0

    10

    Te mp

    Pr ob

    lem s

    Hy po

    gly ce

    mi a

    IV Fl

    uid s

    Re sp

    D ist

    re ss

    Ja un

    dic e

    Late preterm

    McIntire and Leveno, Obstet Gynecol, 2008;111:35-41

    US Late Preterm Singleton US Late Preterm Singleton BirthsBirths

    7%

    5%

    14%

    40%

  • Neonatal Mortality RatesNeonatal Mortality Rates

    *p12 hours from 1Likely to deliver >12 hours from 1stst dose dose

  • 1100 Outcome: Outcome: Respiratory Support or Respiratory Support or

    Death in 1Death in 1stst 72 hours72 hours ●● CPAP or highCPAP or high--flow nasal flow nasal cannulacannula (HHFNC) (HHFNC) ●● Mechanical ventilationMechanical ventilation ●● Oxygen requirement of FiOOxygen requirement of FiO2 2 ≥ 0.3≥ 0.3 ●● ECMOECMO ●● Stillbirth or neonatal deathStillbirth or neonatal death

    ALPS StatusALPS Status ●● 2792 of planned 2800 enrolled (end 2/2015)2792 of planned 2800 enrolled (end 2/2015)

    ●● Completing followCompleting follow--up (3 and 6 months)up (3 and 6 months)

    ●● Expect results within next yearExpect results within next year

    CONGENITAL CMV INFECTION PREVENTION

    TRIAL (CMV Imm ne glob lin)(CMV Immune globulin)

  • Research Question

    ● Does antenatal administration of CMV immune globulin to pregnant women with primary CMV lower the risk of: 1. Congenital CMV infection

    2. Infant neurologic morbidity at age 2

    CMV ●40,000 congenital infections / year ●Primary maternal infection

    – 40% fetal transmission40% fetal transmission ● CMV Immune globulin may prevent

    transmission and reduce sequelae. – Small observational study

    HIG None p-value

    CMV Hyperimmune Globulin Therapy

    NIGRO, NEJM, 2005

    Congenital CMV transmission

    16% 40% 0.04

    Symptomatic CMV 3.2% 50%

  • HIG (N=62)

    Placebo (N=61)

    P-value

    RCT of Hyperimmune globulin

    Revello, NEJM, 2014

    Congenital CMV 30% 44% 0.13

    Adverse obstetric event (PTB, SGA)

    13% 2% 0.06

    Design ● CMV serology – early (

  • ThyroxineThyroxine Therapy forTherapy for Subclinical Hypothyroidism orSubclinical Hypothyroidism or

    HypothyroxinemiaHypothyroxinemia During During PregnancyPregnancy (TSH Trial)(TSH Trial)

    Research Question Is thyroxine treatment of women withIs thyroxine treatment of women with a) subclinical hypothyroidism or a) subclinical hypothyroidism or b) b) hypothyroxinemiahypothyroxinemia diagnosed in the first half of pregnancydiagnosed in the first half of pregnancydiagnosed in the first half of pregnancy diagnosed in the first half of pregnancy associated with intellectual improvement associated with intellectual improvement in their offspring at age 5 years?in their offspring at age 5 years?

    ●● Wechsler Preschool and Primary Scale Wechsler Preschool and Primary Scale of Intelligence (WPPSIof Intelligence (WPPSI--III)III)

    Subclinical thyroid dysfunction ● 3-4% of pregnant women

    – Subclinical hypothyroidism: ↑TSH, ↔ FT4

    – Hypothyroxinemia: ↔ TSH, ↓FT4

    C● Controversy regarding: – Association with low IQ in offspring

    – Ameliorated by treatment during pregnancy

    Haddow, NEJM 1999 Pop, Clin Endo, 1999, 2003

  • Design ● TFT screen – early (

  • Intrapartum monitoring

    Continuous Intrapartum FHR Monitoring

    Cesarean delivery rate %

    66% 85% % US women cEFM in labor

    %

    Trends in CS and CP RatesTrends in CS and CP Rates

    15

    20

    25

    0

    5

    10

    1970 1975 1980 1985 1990 1995 2000

    Cesarean Section Rate Cerebral Palsy Rate

    Clark SL, et al. Am J Obstet Gynecol 2003;188:628-33.

    Sponsored by: NICHD ACOG SMFM