Preterm Labor Assessment

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					Preterm Labor Assessment:
An Evidence Based Toolkit


 Herman L. Hedriana, M.D.
 Sac MFM Medical Group Inc.
 Associate Clinical Professor in Ob/Gyn
 UC Davis School of Medicine
 Mary Campbell Bliss, RN, MS, CNS
 Perinatal Clinical Nurse Specialist
 Sutter Medical Center, Sacramento
Preterm Labor and Delivery (<37 Weeks)
       Preterm Labor
            800,000 (1 in 5) pregnant women in US
             exhibit signs and symptoms of preterm labor
            70% of women identified as “high risk”
             deliver at term
        Preterm Delivery
            >480,000 (12.3%) preterm births in 2003
            Single largest cause of perinatal mortality and
             morbidity
 Sources: National Center of Health Statistic, final natality data
          Retrieved Sept 2005 from www.marchofdimes.com/peristats.
    Preterm Delivery Rates in the US
   27% increase in the
    past 20 years                              12.1
                            12          10.7
   Healthy People 2010          9.5

    and March of Dimes       8


    goal is to reduce the    4
    rate to 7.6% by 2010
                             0
   Leading cause of
                                 1982   1992   2002
    neonatal morbidity
    and mortality
    Preterm Birth Rates in Multiples
   Multiple births
    increased from 2.4% in                 Multiple Birth Ratios US, 1982-2002
    1992 to 3.3% in 2002
                                 30
   At least half of all twins        Rate /1000 live births


    and >90% of higher
                                 20
    order multiples deliver
    preterm
                                 10
   The proportion of
    multiple preterm births      0
    increased 40% from
                                      19

                                      19

                                      19

                                      19

                                      19

                                      19

                                      19

                                      19

                                      19

                                      20

                                      20
                                         82

                                         84

                                         86

                                         88

                                         90

                                         92

                                         94

                                         96

                                         98

                                         00

                                         02
    11.7% in 1992 to
    16.4% in 2002
Preterm Labor
   ICD-9: 644.03
   Acute Disease
       Specific acute treatment
       No effective prophylactic medication
   High recurrence rate
   Multiple triggering factors
Previous Pregnancies &
Risk of Preterm Delivery
 First    Second           Subsequent
                              PTD
 Term                            5%

Preterm                         15%

 Term     Preterm               24%

Preterm   Preterm               33%

                Carr-Hill; Kristensen et al.
Diagnosis of Preterm Labor
   Gestational age 20-37 weeks
   Documented regular UC ≥6/hour
    AND
   At least one of the following:
       Rupture of membranes
       Cervical change
       Cervix 2 cm dilated or 80% effaced
National Economic Burden of
Preterm Labor Hospitalization
   Discharge undelivered: $360,000,000
   All admissions: $820,000,000
   No change in the preterm delivery rate
   Increasing perinatal morbidity
               Nicholson et al. Obstet Gynecol 2000;96:95
What Women Know Re:
Prematurity
March of Dimes survey of 600 pregnant women
 Not viewed as public health issue
 Not seen as serious problem
 Seen as relatively uncommon
 Not see themselves at risk for preterm birth
 Worry about their own unhealthy behaviors


Green, et al, Contemporary OB/GYN, 48(1), 2003.
What Women Know Re:
Prematurity (con’t)
   50% felt they knew signs/symptoms of preterm
    labor
       Amniotic fluid leaks and contractions best known
       Then bleeding, cramps, backache
   Most call physician if experiencing preterm labor

Green, et al., Contemporary OB/GYN, 48(1), 2003
California March of Dimes
Prematurity Prevention Initiative
   Grant to Sutter Medical Center, Sacramento
   Evidence based protocol for symptomatic women
      To establish a uniform diagnosis of PTL
      To guide assessment and diagnosis of PTL
      To avoid unnecessary hospitalizations and
       treatments
      To decrease use of scarce nursing/hospital
       resources
California Maternity Hospitals
   285 hospitals and birth centers
   Provide all levels of care
   Goal of the grant:
       One standard assessment for symptomatic
        PTL patients
Preterm Labor Practice Assessment
Prior to development of toolkit:
 Collected PTL protocols from Northern CA
   hospitals
 Developed grids with urban/rural and
   NICU/no NICU groupings
 Analyzed for commonalities/differences
 Identified research articles for review
                                              A      B      C      D      E      F
D
E
F O
I F
N
I P
                                              Y      N      N      Y      Y      N
T T
I L
O
N
 A                     History                Y      Y      N      Y      Y      Y
 S
 S               Review of Prenatals          Y      Y      N      Y      Y      N
 E                       EFM
 S
                                              Y      Y      Y      Y      Y      Y
 S                  PO Hydration              Y*     N      N      N      Y      Y
MD           MD Notification within 30-60'    Y      Y      Y      Y      Y      Y
IV                  IV Hydration*             Y      N      N      Y      Y      Y
 L                 R/O UTI-UA C/S*            Y      Y      N      Y      Y      Y
 A                Fetal Fibronectin*          Y      N      N      Y      Y      N
 B             Vaginal Cultures (GBS)*        N      Y      N      N      N      N
 S
                Rectal Cultures (GBS)*        N      Y      N      N      N      N
                   SQ Terbutiline*            Y      N      N      Y      Y      Y
M                      MGS04*                Y-IP   Y-IP   Y-IP   Y-IP   Y-IP   Y-IP
E
D
                    Indomethacin*            Y-IP   Y-IP    N     Y-IP    N     Y-IP
S                    Nifedipine*             Y-IP   Y-IP    N     Y-IP    N     Y-IP
                      Other RX                N      N      N      N      N     Y-IP
      Ultrasound for Cervical Lengths*
                                              N      N      N      N      N      N
      (Abdominal vs Transvaginal)
 D
 X
                    Vaginal Exam*             Y      N      N      Y      Y      Y
           Sterile Speculum Exam Per MD*      N      N      N      Y      Y      Y
             Speculum Exams Per RNs*          N      N      N      Y      Y      Y
                Prepare for Transport*        N      N      N      N      Y      N
                 Antenatal Steroids*          Y      Y      Y      Y      Y      Y
           * = Requires MD/HCP Orders
                IP = Inpatient Orders
Preterm Protocol Findings
   Consistent in some areas
       Electronic fetal monitoring
       MD notification
       Review of prenatal record/patient history
   Wide variation in other areas
       Definition of preterm labor
       Use of fetal fibronectin
       Sterile speculum exams/vaginal exams
       Disposition choices/criteria
Preterm Labor Diagnosis
Reviewed current research and relevance to
the diagnosis of preterm labor:
 Uterine contractions
 Fetal fibronectin
 Cervical length
 Initial goal: Sensitivity of the test
 Goal of evaluation: Specificity of the test
Labor Pain
   Persistent uterine contractions accompanied by
    dilation and/or effacement of the cervix
    detected by digital examination
                   Gonik and Creasy AJOG 1986:154;3
   Perceived contractions painful or painless but
    persistent
   Pelvic pressure, increased vaginal discharge,
    backache, menstrual-like cramps
   All found in term labor
   Poor sensitivity and specificity
       Likelihood in 7-14 days
Uterine Contractions/PTD Risk
   306 women with hx of PTD or 2nd trimester
    bleeding
   11 sites – from 1994-1996
   Monitored contraction 2X/day = 39,908 hours
   Assessed fFN, Bishop scores, digital exams, and
    cervical length
   Freq. of cont. higher in PM/evening hours with
    increasing gestation.
Iams, J.D. et al. 2002
Uterine Contractions/ PTD Risk
    Significant related to PTD, BUT low sensitivity
     and low positive predictive value for
     asymptomatic women
    Conclusion: Increased contractions for any
     individual woman is more likely to reflect
     advancing gestation and diurnal variation than
     occult preterm labor

Iams, J.D. et al. Frequency of Uterine Contractions and the Risk of Spontaneous Preterm
     Delivery. N Eng J Med 2002, 346:250-5.
Frequency of Uterine
Contractions
   4 contractions or more              Gestational                  Positive
   Low probability of                     Age        Sensitivity   Predictive
    preterm birth in 7-14 days           (weeks)                      Value
   Degree of pain is                     22-24          9%           25%
    irrelevant
                                          27-28          28%          23%
   Initiating treatment results
    in unnecessary exposure
    to tocolytics
                   Hueston BJ Obstet
                    Gynecol
                    1998;92:38
                   Iams et al NEJM
                    2002;346:250
Digital Examination
   3 cm/80%/vtx/0/SROM/BRB
         Best clinical sign
         95% PPV in 7-14 days
                Hueston BJ Obstet Gynecol 1998;92:38

   Assess the structure of the external os
   No clinical value if cervix is < 2cm or
    < 80% effaced
                Iams et al Obstet Gynecol 1994;84:40
Fetal Fibronectin (fFN)
   Protein related to cellular cohesiveness
   High levels at membrane-decidua interface
   Disruption of interface releases fFN
   Protein detected via immunoassay
   Positive test > 50 ng/ml
Fetal Fibronectin

                    Amnion
                    Chorion
                    Fetal
                    Fibronectin
                    Decidua
 Fetal Fibronectin vs Gestational Age
                                    4500
        Fetal Fibronectin (ng/mL)




                                    4000                     Clinically Relevant Time Frame
                                    3500                              (22-35 weeks)
                                    3000
                                    2500

                                    2000
                                    1500
                                    1000
                                     500
                                                                                              50 ng/mL
                                      0                                                       Cutoff Level
                                           0   5   10   15     20   25     30    35    40



                                                   Gestational Age (weeks)

Source: Adapted from Garite TJ et al. Contemp Obstet Gynecol. 1996;41:77-93.
Clinical Value of fFN
    Cervix < 3cm, <80% effaced & IBOW
    Sensitivity is 90%
    Excellent negative predictive value within 7-14
     days
        97 - 99% (24 – 28 weeks)
        95% (>28 - <34 weeks)
    Poor positive predictive value (18-20%)
                    Iams et al AJOG 1995;173:141, Peaceman et al AJOG
                     1997;177:13, Leitich et al AJOG 199;180:1169
A Negative fFN Test
Based on the high negative predictive
value (NPV) of fFN, decreased levels of
intervention are possible:
 Reassurance and education for patient
 Ongoing prenatal surveillance
 Avoidance of tocolytic agents
 Less disruption of patient’s lifestyle
    Continue care of immediate family
    Continue work
    Normal ADLs
fFN in Clinical Care Algorithms
   Not for establishing diagnosis
       Exclusion (NPV) is its strength
       Included in algorithms to exclude the likelihood of
        preterm labor
   Must be rapidly available
   Commitment to act on the result by not starting
    tocolytics
   3 published studies demonstrating possible impact
    on cost savings
fFN in Clinical Care Algorithms
   In a tertiary setting:
       fewer admission for PTL, shorter hospital stay, less
        tocolytic exposure, no adverse neonatal outcome
       $486,000 saved in charges
                    Joffe et al AJOG 1999:180;581
   In community hospital setting:
       no benefit in > 3 cm cervical dilation; 90% reduction of
        transfers to tertiary facility
                    Giles et al AJOG 2000:182;439
   Savings do not show in cost analysis models in a
    large teaching facility (Bethesda)
                    Sullivan et al JMFM 2001:10;1
Length of Cervix and the Risk of
Preterm Delivery @ 24 wks
Cx (mm)   RR
   5      52
   10     9.1
   15     2.7
   20     1.2
   25     0.7
   30     0.5
   40     0.5
Reliability of Cervical Length
   Consistent images in more
    than 95% of patients
    regardless of habitus and
    order of multiples
           Strict adherence to criteria
   Superior Positive Predictive
    Value (PPV) to digital
    exam
   Cervical length of 30 mm
    or more have very high
    Negative Predictive Value
Combining Cervical Length and
Fetal Fibronectin
   Improves accuracy of diagnosis
               Goldenberg et al AJPH 1998:88;233, Rizzo et al
                AJOG 1996:175;1146

   In diagnosis, combined is not superior to
    either one alone.
               Rozenberg et al AJOG 1997:176;196

   Strength consistently with exclusion
               Goldenberg et al AJPH 1998:88;233
Toolkit Definition of Preterm Labor
    Persistent uterine contractions
    Objective documentation of cervical
     change
    Dilated to > 2 cm or 80% effaced
    Positive biochemical marker
Preterm Labor Taskforce
Consensus Decisions
   Labor is consistent contractions with
    cervical change
   Rapid fFN chosen as screening test for
    preterm labor in symptomatic patients
   Transvaginal ultrasound for cervical length
    is used as an adjunct of fFN
   Decision to admit, discharge, transport to
    be made within 4 hours
PTL Assessment Toolkit Contents
   PTL Care/Disposition Protocol/Algorithm
   PTL Assessment Pre-Printed Orders
   PTL Home Care Instructions
   PTL Patient Education
   Procedures (Speculum, GBS, Ferning)
   Competencies
   PTL Power Point Presentations
Preterm Labor
Care/Disposition Protocol
   Confidence that uterine contractions alone
    DO NOT mean labor
   Contains a logical sequence of events
   Disposes of clinical concerns
   Should allow for a decision within 4 hours
    of admission
Evaluation of Symptomatic
Preterm Labor
 Review of history
 Fetal heart and contraction monitoring
 Cervical examination - look for best clinical
  sign
 Severity of symptoms bears very little to
  clinical significance
 Do not initiate tocolytics unless FFN and/or
  cervical length is assessed
EFM                    COMPONENTS OF PTL                HISTORY
PSYCHO-SOCIAL        ASSESSMENT ALGORITHM
                                                        SUPPORTIVE DATA
ASSESSMENT
                         SYMPTOMATIC WOMEN
                                                        PHYSICAL
MEDICAL ASSESSMENT       20-37 WEEKS GESTATION
                                                        ASSESSMENT

FETAL ASSESSMENT                                     UA RESULTS
                      PRETERM LABOR ASSESSMENT
MEMBRANE STATUS                                      RISK ASSESSMENT
                                                     FLANK PAIN
                                                     SEXUAL
                                                     INTERCOURSE
                                                     DEHYDRATION
  HYDRATION                 PRETERM LABOR
  PO OR IV                 SUPPORTIVE CARE
                                                   POSITIONING


                          NOTIFY PHYSICIAN       STERILE SPECULUM EXAM


                           TESTS ORDERED         GROUP B STREP CULTURE
                                                 FETAL FIBRONECTIN


        LABS                                     STERILE VAGINAL EXAM
        ULTRASOUND
                                                 CERVICAL STATUS
                                                 ASSESSMENT
Preterm Labor Assessment
Pre-Printed Physician Order Set
   Concise MD order set
   Rules out specific pathology
   Sterile speculum exam for fFN
   EFM monitoring for fetal
    wellbeing
Homecare Instructions
   Bedrest not effective
   Minimally restrictive
   Effective follow-up important
       Telephone calls
       Frequent office visits
Preterm Labor Patient Education
   “Street-smart” patients/clients
   Stay with the facts….decrease
    confusion
       Information is readily accessible
   Friendly, easy reading
   Warning signs to contact provider
Capping Off the Toolkit
   Sterile Speculum procedure
   GBS Procedure
   Nursing Competencies
       Sterile speculum exam
       Fern testing
   PTL Assessment Reference List
Preterm Labor Assessment Toolkit
 A great opportunity to :
       Standardize preterm labor
        assessment/disposition
       Maintain maternal/fetal safety
       Promote patient satisfaction
        ANY QUESTIONS???
   Contact Mary Campbell Bliss at (916)
    733-8471 or Blissm@sutterhealth.org