Disclosures Dr. Iams has contracts via Ohio State University with: NICHD for clinical research projects OPQC for quality improvement projects Elsevier for editorial & authorship roles in AJOG and Creasy & Resnik’s MFM textbook

Objectives

34.3% Prematurity is the Most Common Cause of Infant Mortality 34.3% of Infant Deaths Are Caused by Preterm Birth

2010 Infant Mortality Rates

March of Dimes 2013 Report Card Premature Birth Rate

Rates of Contributing Factors Grade Uninsured Women Uninsured Women17.8%17.0%  Late Preterm Birth Late Preterm Birth 8.2% 8.1%  Women Who Smoke Women Who Smoke30.6%27.3% 

The Medical Model of Care for Preterm Birth BandAid

Care for Preterm Birth During Pregnancy  Detection & Suppression of Contractions  Detection & Suppression of Infections  Detection & Replacement of Nutrients Calcium  Calcium, Omega-3, Protein, Vitamins C + E  Detection & Surgical Rx of Short Cervix  Detection & Attention to Social Support Progesterone  Progesterone   ???

% 11.7% %

Who Decreased the Preterm Birth Rate?

Report issued Nov 2011 by CDC – NCHS * ASRM Statements On Fertility Care And Twins, Triplets, & Higher Order Multiples *

Decreasing Non-Medically Indicated Scheduled Deliveries Between 37 and 39 Weeks Gestation OPQC 39 Weeks Project in Sustain Phase Decreasing Non-Medically Indicated Scheduled Deliveries Between 37 and 39 Weeks Gestation 14 5% Goal Data Is From All Ohio Maternity Hospitals 105 of 107 Hospitals Participated in the OPQC 39 Week Project

% 11.7% %

Obstetricians Have The Band Aids Antenatal SteroidsAntenatal Steroids o Review Documentation of ANCS Use o Systems Improvements in Birth Registry o Publish Rates of Documented Use Progesterone SupplementationProgesterone Supplementation o Women with a prior preterm birth o Women with short cervix in this pregnancy BandAid

Birth Registry Documentation of ANCS Use Aggregate Rate in 19 OPQC Sites

The Ohio OPQC Progesterone Project Goal: Reduce Ohio PTB & Related Infant Mortality o Reduce Preterm Birth < 37 & 32 Weeks by 10% by Find Women with Prior Preterm Birth Find Women with Short Cervix Make it Easy to Prescribe and Rx Progesterone o Protocols, Medicaid & Insurance Support, Navigators Outcome Measures o Preterm Birth Rate Medicaid Data Birth Registry Data – Births < 32 & 37 Weeks o Process Measures The Infant Mortality Rate o The Infant Mortality Rate

Why?  Preterm Birth  Largest Contributor to Infant Mortality  Preterm Birth  Largest Driver of Disparity in PTB Who?  Women with a Prior Preterm Birth  Women with Very Short Cervical Length How? Find & Rx Candidates for Progestogens When? ASAP – in Ohio & in Each Pregnancy

Find a Progesterone Protocol You Like And Use It. Here’s One. Find One That Fits YourPractice.

What Formulations of Progestogens Should Be Used? Standard Answers:  Hx SPTB: 17-OHPC 250 mg IM Q 7d 16  36 wks  Short Cx ≤ 20 mm: Vag P, 200 mg QHS, Dx  36 wks But Life is Not That Simple  17-OHPC – Manufactured vs. Compounded  Cost vs. Hassle  Vaginal P – multiple formulations - which to Rx?  Who pays for what, when, & after how much hassle?

Initiate Progesterone ASAP for Hx SPTB Initiate Progesterone ASAP for Hx SPTB  Accelerated 1 st Prenatal Visit  Presumptive Eligibility for Antenatal Care Adopt a Local Management Protocol Adopt a Local Management Protocol  For Hx SPTB  For Short Cervix  Test them via OPQC ! Make “Screen for PTB Risk” ≈ GBS, Rh, GDM Make “Screen for PTB Risk” ≈ GBS, Rh, GDM

LEAR/ f/online-education/05-cervical- assessment/ The Importance of Credentialing for Cervical Sonography Iams JD et al. Am J Obstet Gynecol 2013

OPQC’s Tasks: Remove Administrative Barriers to Receiving Progesterone Supplementation Pharmacy Coordination Insurance / Medicaid Coverage & Protocols Delivery and Administration of 17 α- OHPC Use of Vaginal Formulations  Generic 200 mg capsules = cheapest & fastest Rx Designate a Progesterone Coordinator Convene Participants to Assure Rx Received

What Have You Told OPQC About That? Why Are We Missing P-Eligible Women? What Have You Told OPQC About That? YesDo Providers Know About Progesterone? Yes. Yes, mostlyDo Providers Know What to Rx? Yes, mostly. Do Providers Know The Rx Gets to Patient? Not So Much Not So Much. Yes, mostlyDo Providers Know Why Women Don’t Seek Care ‘til It’s Too Late? Yes, mostly. Not So MuchDo Providers Know What They Can Do To Overcome That? Not So Much.

What Have Providers Done About Late for Care? No Appointment Needed!No Appointment Needed! –1 st Visits Welcomed Anytime in Cincinnati Community Open Houses with Food PrepCommunity Open Houses with Food Prep –“Moms2B” in Columbus Builds Social Networks Business Community InvolvementBusiness Community Involvement –Ohio Metro Counties Have High Infant Mortality High Infant Mortality = A Measure of Community HealthHigh Infant Mortality = A Measure of Community Health –Bring Your Business Here? No Way! Goin’ to Georgia! Hospital Geographic Responsibility for HealthHospital Geographic Responsibility for Health

Improving Access to Progesterone in Ohio Drive Community Changes to Increase Awareness of PTB as Cause of Infant MortalityDrive Community Changes to Increase Awareness of PTB as Cause of Infant Mortality Increase Avenues to Enter Prenatal CareIncrease Avenues to Enter Prenatal Care Recognize Candidates at First ContactRecognize Candidates at First Contact Accelerate Appts & THEN get detailed OB HxAccelerate Appts & THEN get detailed OB Hx Track Receipt of Progesterone After RxTrack Receipt of Progesterone After Rx Think Outside the Medical Paradigm to Find Eligible Women Late To Prenatal CareThink Outside the Medical Paradigm to Find Eligible Women Late To Prenatal Care

Publish The Data for Your County & Your State:Publish The Data for Your County & Your State: o Infant Mortality, Preterm Birth, & Smoking. o Scheduled Births < 39 Weeks – 1% goal. o Multi-fetal Pregnancy Rates. o Antenatal Corticosteroids. o Include Racial Disparity Rates for All the Above. Track All Over TimeTrack All Over Time – Use Graphs, Not Tables. Promote Public AwarenessPromote Public Awareness o Risks of Preterm Birth o Prevention with Progesterone o Availability of Cervical Ultrasound