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Preterm Labor Assessment: An Evidence Based Toolkit

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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 – PowerPoint PPT presentation

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Title: Preterm Labor Assessment: An Evidence Based Toolkit


1
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

2
Preterm Labor and Delivery (lt37 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
  • gt480,000 (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.
3
Preterm Delivery Rates in the US
  • 27 increase in the past 20 years
  • Healthy People 2010 and March of Dimes goal is to
    reduce the rate to 7.6 by 2010
  • Leading cause of neonatal morbidity and mortality

4
Preterm Birth Rates in Multiples
  • Multiple births increased from 2.4 in 1992 to
    3.3 in 2002
  • At least half of all twins and gt90 of higher
    order multiples deliver preterm
  • The proportion of multiple preterm births
    increased 40 from 11.7 in 1992 to 16.4 in 2002

Multiple Birth Ratios US, 1982-2002
Rate /1000 live births
5
Preterm Labor
  • ICD-9 644.03
  • Acute Disease
  • Specific acute treatment
  • No effective prophylactic medication
  • High recurrence rate
  • Multiple triggering factors

6
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.

7
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

8
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 20009695

9
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.

10
What Women Know Re Prematurity (cont)
  • 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

11
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

12
California Maternity Hospitals
  • 285 hospitals and birth centers
  • Provide all levels of care
  • Goal of the grant
  • One standard assessment for symptomatic PTL
    patients

13
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

14
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15
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

16
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

17
Labor Pain
  • Persistent uterine contractions accompanied by
    dilation and/or effacement of the cervix detected
    by digital examination
  • Gonik and Creasy AJOG 19861543
  • 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

18
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

19
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, 346250-5.

20
Frequency of Uterine Contractions
  • 4 contractions or more
  • Low probability of preterm birth in 7-14 days
  • Degree of pain is irrelevant
  • Initiating treatment results in unnecessary
    exposure to tocolytics
  • Hueston BJ Obstet Gynecol 19989238
  • Iams et al NEJM 2002346250

Gestational Age (weeks) Sensitivity Positive Predictive Value
22-24 9 25
27-28 28 23
21
Digital Examination
  • 3 cm/80/vtx/0/SROM/BRB
  • Best clinical sign
  • 95 PPV in 7-14 days
  • Hueston BJ Obstet Gynecol 19989238
  • Assess the structure of the external os
  • No clinical value if cervix is lt 2cm or
  • lt 80 effaced
  • Iams et al Obstet Gynecol 19948440

22
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 gt 50 ng/ml

23
Fetal Fibronectin
Amnion
Chorion
FetalFibronectin
Decidua
24
Fetal Fibronectin vs Gestational Age
Clinically Relevant Time Frame (22-35 weeks)
Fetal Fibronectin (ng/mL)
50 ng/mL Cutoff Level
Gestational Age (weeks)
Source Adapted from Garite TJ et al. Contemp
Obstet Gynecol. 19964177-93.
25
Clinical Value of fFN
  • Cervix lt 3cm, lt80 effaced IBOW
  • Sensitivity is 90
  • Excellent negative predictive value within 7-14
    days
  • 97 - 99 (24 28 weeks)
  • 95 (gt28 - lt34 weeks)
  • Poor positive predictive value (18-20)
  • Iams et al AJOG 1995173141, Peaceman et al AJOG
    199717713, Leitich et al AJOG 1991801169

26
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 patients lifestyle
  • Continue care of immediate family
  • Continue work
  • Normal ADLs

27
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

28
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 1999180581
  • In community hospital setting
  • no benefit in gt 3 cm cervical dilation 90
    reduction of transfers to tertiary facility
  • Giles et al AJOG 2000182439
  • Savings do not show in cost analysis models in a
    large teaching facility (Bethesda)
  • Sullivan et al JMFM 2001101

29
Length of Cervix and the Risk of Preterm
Delivery _at_ 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
30
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

31
Combining Cervical Length and Fetal Fibronectin
  • Improves accuracy of diagnosis
  • Goldenberg et al AJPH 199888233, Rizzo et al
    AJOG 19961751146
  • In diagnosis, combined is not superior to either
    one alone.
  • Rozenberg et al AJOG 1997176196
  • Strength consistently with exclusion
  • Goldenberg et al AJPH 199888233

32
Toolkit Definition of Preterm Labor
  • Persistent uterine contractions
  • Objective documentation of cervical change
  • Dilated to gt 2 cm or 80 effaced
  • Positive biochemical marker

33
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

34
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

35
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

36
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

37
COMPONENTS OF PTL ASSESSMENT ALGORITHM
EFM PSYCHO-SOCIAL ASSESSMENT MEDICAL ASSESSMENT
HISTORY SUPPORTIVE DATA PHYSICAL ASSESSMENT
SYMPTOMATIC WOMEN 20-37 WEEKS GESTATION
  • UA RESULTS
  • RISK ASSESSMENT
  • FLANK PAIN
  • SEXUAL INTERCOURSE
  • DEHYDRATION

FETAL ASSESSMENT MEMBRANE STATUS
PRETERM LABOR ASSESSMENT
PRETERM LABOR SUPPORTIVE CARE
HYDRATION PO OR IV
POSITIONING
NOTIFY PHYSICIAN
STERILE SPECULUM EXAM
GROUP B STREP CULTURE FETAL FIBRONECTIN
TESTS ORDERED
STERILE VAGINAL EXAM
LABS ULTRASOUND
CERVICAL STATUS ASSESSMENT
38
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

39
Homecare Instructions
  • Bedrest not effective
  • Minimally restrictive
  • Effective follow-up important
  • Telephone calls
  • Frequent office visits

40
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

41
Capping Off the Toolkit
  • Sterile Speculum procedure
  • GBS Procedure
  • Nursing Competencies
  • Sterile speculum exam
  • Fern testing
  • PTL Assessment Reference List

42
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_at_sutterhealth.org
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