Download The Western Australian Preterm Birth

9/07/2015
The Western Australian Preterm Birth
Prevention Initiative
John Newnham
School of Women’s and Infants’ Health
The University of Western Australia,
Perth, Western Australia
Estimated Preterm Birth Rates 2010
The Western Australian Preterm Birth Prevention Initiative
The problem
For the mother
Increased risks of obstetric intervention and separation from child
For the newborn
Increased risks of death, cerebral haemorrhage, respiratory support,
bowel necrosis and sepsis
For children
Increased risks of cerebral palsy, chronic lung disease, deafness,
blindness, learning difficulties and behavioural problems.
Preterm birth is the single greatest cause of death and disability
in children under 5 years in developed countries
Is #2 in developing countries
For adults
Increased risks of metabolic syndrome, diabetes/heart disease,
loss of employment and socialisation issues.
Blencowe et al, Lancet 2012
THE WESTERN AUSTRALIA PRETERM BIRTH PREVENTION INITIATIVE
Protocol
Development
Fundraising
(WIRF)
Preterm Birth
Prevention
Clinic
State-Wide
Outreach
Program
Public
Health
Program
Operation
In Western Australia:
• 8-9% of all births in WA are preterm
• 14-15% in Aboriginal Australians
• Approximately 2800 preterm births from 33,000 births each year
Development
Aim:
To safely lower the rate of preterm birth in Western Australia
Steering
Committee
Stakeholders
Executive Committee
Governance
The Western Australian Preterm Birth Prevention Initiative
Ongoing research; Monitoring and analysis
Community engagement
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Outreach for the general public
•
•
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Mailed to 2718 medical
practitioners in WA
November 2014
16-page magazine
State-wide distribution
160,000 copies sent
Readership 624,000
Feb 25th, 2015
The Western Australian Preterm Birth Prevention Initiative
Providing Medical practitioners and midwives with education
on the clinical guidelines and scientific basis underpinning
The Western Australian Preterm Birth Prevention Initiative (The Whole Nine MonthsTM).
The financial cost:
•
In USA in 2007, the cost of immediate PTB was $US 26 billion.
•
In Perth North Metro Region neonatal cost is $116 million each year
•
In KEMH the direct cost of neonatal care is $54 million each year.
Business Case:
The Clinic component of the Initiative is cost-effective if in one year it:
• Prevents the birth of just two newborns <750g
Or
• Delay the birth of three newborns from <750g to 1500–1999g weight range
Progesterone treatment for women based on a history of preterm birth
The Western Australian Preterm Birth Prevention Initiative
The Six Strategies
Rate of
reduction
NHMRC Level of
Evidence
IM
1
Progesterone supplementation
45%
Level I
2
Cervical cerclage
20%
Level III-1
3
Prevent non-medically indicated
late preterm birth
55%
Level III-3
4
Tobacco control
• Prevent smoking in pregnancy
• Smoke-free legislation
20%
10%
Level III-2
Level III-3
5
Judicious use of fertility treatments
63%
Level I
6
Dedicated PTB Prevention Clinic
13%
Level III-2
Vaginal
Total
Progesterone reduces the risk of recurrent birth <37 weeks by half
Cochrane, 2013
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Progesterone treatment based on history
The short cervix on trans-vaginal scan
Clinical guideline:
In women with a past history of preterm birth or a previous pregnancy loss
between 20 and 34 weeks gestation.
The treatment should commence at 16 weeks and continue until
36 weeks gestation.
In this circumstance, the progesterone treatment will halve the risk of
recurrence of a preterm birth.
Progesterone treatment based on length of cervix
Short with open cervix
Normal
The Hassan/Romero RCT of vaginal progesterone
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Vaginal progesterone halves the risk of PTB in women with a short cervix
190 to 236 weeks gestation
Cervix 10-20 mm (2.3%)
Primary end-point: birth <33 weeks
Multi-centred USA
32,000 women screened
Hassan S et al Ultrasound Ob Gyn 2011:38:18
The Hassan/Romero RCT of vaginal progesterone
• Outcomes
• Vag Prog
(n)
• Placebo (n)
• P value
• Birth < 28 weeks
• 12/235
• 23/223
• 0.036
• Birth < 33 weeks
• 21/235
• 36/223
• 0.020
• Birth < 35 weeks
• 34/235
• 52/223
• 0.016
• Birth < 37 weeks
• 71/235
• 76/223
• 0.376
• Effect only at earlier gestational ages
• Screened 32,000 to prevent 15 births < 33 weeks (treatment arm)
Screening the cervix in Western Australia
• Measurement of cervix length is now recommended
at all 18-20 weeks anatomy scans
• Trans-abdominal scan is satisfactory if the pregnancy is
low risk and length >35 mm.
• All other measurements to be trans-vaginal.
In WA in 2013, we had 482 births <33 weeks (1.4%)
• State-wide standardised guidelines and education package
Therefore, in one year in WA, if we screened 32,000 pregnancies
at their routine 18-20 week scan,
we would identify 733 suitable women (2.3%)
and prevent 47 births < 33 weeks (15x2 add 1/3rd)
• Effects of implementation will be monitored
Hassan S et al Ultrasound Ob Gyn 2011:38:18
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1. Progesterone treatment
Progesterone treatment based on cervix length
Vaginal progesterone pessaries
Clinical guideline:
100 or 200mg
In pregnant women found on ultrasound imaging between 16 and 24 weeks
gestation to have a shortened cervix with a length between 10 and 20mm.
Cost to public hospitals $120/month
($4 each)
The incidence of shortened cervix at this gestational age in the general population
is 2-3%.
Costs to patients:
• Public patients $29.50 per month
($1 each)
• Concession card holders $6 per month
(20 cents each)
When prescribed in this circumstance, the treatment will halve the risk of early
preterm birth.
If the cervix length is <10mm, the options include progesterone or cerclage.
Costs in private variable
PBS only for Assisted Reproduction
Progesterone treatment to prevent preterm birth
2. Prevention of non-medically indicated late preterm birth
Late preterm birth - 340/7 to 366/7
Day
1
239
259
280
366/7
40
• Only applies to pregnancies with a single fetus
• Evidence at this time suggests is ineffective in multiple pregnancies
Week
LMP
340/7
72% of all preterm births are “late preterm”
The Western Australian Pregnancy Cohort
1989-2014
Late preterm births
Increased rates of:
• Death
• Respiratory problems – RDS, “wet lung”, apnea
• Hypothermia
• Hypoglycemia
• Jaundice
• Feeding difficulties
• Sepsis
• Neonatal care
• Separation from mother
• Re-admission
Infants born between 37 0 and 376 weeks had increased behavioural problems:
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Overall (OR 1.43, 95% CI 1.02, 2.01)
Externalising (OR 1.42, 95% CI 1.01, 2.01)
N = 238 out of 2900
No effect at 38 weeks
In childhood:
• Learning difficulties
• Behavioural problems
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Percentage of all liveborn births <32 and 32-36 weeks gestation
in Western Australia
Singleton preterm birth rates - USA
Intervention
Fig 2 Shapira-Mendoza 2012
Preterm births 32-36 weeks have increased by 50% in 27 years
• 1990-2006 rate of singleton late PTB rose 21%
• Late PTB accounted for almost all the increase
• Effective reduction since then
Shapiro-Mendoza 2012
Three strategies to reduce non-medically indicated
birth <39 weeks gestation in USA
Three strategies to prevent non-medically indicated birth <39 weeks
USA 2007
• 27 hospitals in 14 states in 2007;
• 3 month period including >17,000 births
Hard stop
After education, medical staff in each facility could choose:
Soft stop
1. “Hard Stop” All pure elective births < 39 weeks prohibited
2. “Soft Stop”
Education
No prohibition, but all elective births <39 weeks
reviewed for potential action
3. “Education only”
Effectiveness:
Hard stop > Soft stop > Education
Clark et al, AJOG 2010; 203: 449.e1-6.
Non-medically-indicated late preterm births
Balancing preterm birth versus risk of stillbirth
Our strategy:
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Prevention of non-medically indicated
late preterm birth
Clinical guideline:
All pregnancies should continue until at least 38 weeks gestation,
unless there is a medical or obstetric reason
justifying earlier intervention
Cut-off 38+ weeks
Education of workforce
Awareness raising in our childbearing women
Use of tests of fetal wellbeing if required
Audit
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6. The Preterm Birth Prevention Clinic
4. Smoking in pregnancy
In Western Australia 2010 – 2012:
• 14% of pregnant women smoked
• 49% of Aboriginal pregnant women smoke and the rate is unchanged
• Smoke-free legislation is the most effective strategy
• We will harness the excellent public policies from our Health Department
• But our public health messages have not been aimed at preterm birth prevention
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For referral of women at high risk based on history.
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Expect 1-3 visits and then referral back to health care provider
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Most women will only need a treatment plan
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Teleconferencing whenever possible
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Linked to the KEMH MFM (Gold) Team
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Commenced November 2014
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Is a pilot to be evaluated in mid-2015
The Western Australian Preterm Birth Prevention Initiative
The Western Australian Preterm Birth Prevention Initiative
Research:
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PTB Prevention is a major research
area for us
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Funded by NIH and NHMRC >24
years
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New NHMRC vaginal microbiology
project grant 2015-17.
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Targeting intra-uterine infection in
2nd trimester
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Genetic predictions show promise
WA PTB Prevention Initiative - Steering Committee
Data monitoring and analysis:
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Western Australia is the ideal “island”
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Outcomes to be monitored by Midwifery Notifications
and data linkage
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Cost-effectiveness evaluated
Let’s keep in touch
Name
Organisation
John Newnham
Chair
Graeme Boardley
A/Executive Director, WNHS
John Challis
Pro-VC Health & Medical Research UWA
Jan Dickinson
Head, MFM, KEMH
Women and Infants Research
Foundation
Dorota Doherty
Head of Biostatistics, WIRF
The Whole Nine Months
Michael Gannon
President, WA Branch, AMA
Janet Hornbuckle
Head, Obstetrics, KEMH
@WIRFWA
Anne Karczub
Director, Obstetrics, KEMH/SOSU
Jeffrey Keelan
Head of Research, WNHS
Barbara Lourey
Clinical Midwifery Manager, KEMH
Suzanne Meharry
Obstetrician, PTB Prevention Clinic
Diane Mohen
Co-Director, SOSU
Craig Pennell
Head of PTB Prevention Clinic
Bronwyn Rose
CE, Tiny Sparks WA
Tarun Weeramanthri
Head, Public Health, WA Health Dept
Vicki Westoby
GP Liaison Officer, KEMH
Tina Williams
Operations Manager, WIRF
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