WATCHING OVER MOTHERS & BABIES

THE WATCHING OVER MOTHERS & BABIES (WOMB) FOUNDATIONCONDUCTS RESEARCH IN PARTNERSHIP TO IMPROVE THE HEALTH ANDOPTIONS FOR PREGNANT WOMEN AND CHILDREN. THESE EFFORTSSERVE TO OFFER BETTER TREATMENTS FOR PREGNANT WOMEN AND CHILDREN IN THE PURSUIT OF IMPROVING PERINATAL & NEONATAL OUTCOMES. HISTORICALLY WOMB WAS ENGAGED IN A COMBINATION OF INNOVATIVE RESEARCH DEVOTED TO THE TREATMENT OF TOBACCO USE IN PREGNANCY IN AN EFFORT TO INCREASECESSATION RATES AMONG PREGNANT WOMEN. WHILE THAT GOAL REMAINS, WOMB HAS DIVERSIFIED AND IS COMMITTED TO ADDRESSING OTHER IMPORTANT HEALTH INITIATIVES MOST RECENTLY WOMB HAS APPLIED FOR RESEARCH FUNDING TO APPLY SEVERAL OF THE SAME PRINCIPLES TO OPIOID DEPENDENCE DISORDER INAN EFFORT TO BETTER MANAGE OPIOID USE IN PREGNANCY. WOMB IS STILL EVALUATING ITS SUCCESS WITH MOTIVATIONAL COUNSELING DIRECTED AT THE PREGNANT WOMEN AND HER PARTNER TO ASSIST IN THE SMOKING CESSATION. THIS PROJECT IS CALLED "FAMILY ALLIANCE AND ITS USE OFMOTIVATIONAL COUNSELING IS BEING COMPARED TO THE STANDARD PRESCRIPTIVETECHNIQUES MORE COMMONLY USED IN CLINICAL PRACTICE. THE ARIZONA DISEASE CONTROL RESEARCH COMMISSION, NOW CALLED THE ARIZONA BIOMEDICAL RESEARCH COMMISSION PROVIDED THE EARLY FUNDING FOR THIS TRIAL. IN THE EARLY PHASE OF THIS STUDY, DR. MILLER WAS STILL FULL-TIME FACULTY AT THE UNIVERSITY OF ARIZONA, HOWEVER UPON LEAVING HIS POSITION, HE DESIRED TO CONTINUE THIS WORK THROUGH THE CREATION OF THE WOMB FOUNDATION.IN THE PAST SEVERAL YEARS WOMB HAS BECOME MORE INVOLVED IN VACCINE RESEARCH. THE WORK WAS FOCUSED ON REDUCING THE RISK OF RSV BY IMMUNIZING PREGNANT WOMEN AND CONVEYING PASSIVE IMMUNITY TO THE FETUS AS WE DO WITH SEVERAL OTHER VIRAL INFECTIONS SUCH AS INFLUENZA AND PERTUSSIS. THIS WORK BECAME EVEN MORE IMPORTANT OVER THE PAST FEW YEARS AS OPPORTUNITIES TO STUDY COVID EMERGED. THE GOAL OF SIGNIFICANTLY REDUCING RSV IN THE NEONATE ALONG WITH THE MORBIDITY AND MORTALITY CONTINUES TO BE A SERIOUS PROBLEM. AS A RESULT MORE COMPANIES HAVE ENTERED THE FIELD AND THE COMMITMENT TO THIS RESEARCH QUESTION HAS EXPANDED. WOMB HAS BEEN FORTUNATE TO PLAY A SMALL ROLL IN THIS RESEARCH. THIS WORK BRIDGES THE MATERNAL-NEONATAL FIELDS WHICH HISTORICALLY HAS BEEN DIFFICULT TO DO.OTHER ACTIVE RESEARCH ACTIVITIES INCLUDE:1. PFIZER HAS BEEN DEVELOPING A RSV VACCINE AND LAUNCHED AN RCTIN 2018. A PHASE 2B RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLEDTRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIALVIRUS (RSV) PERFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMENVACCINATED DURING PREGNANCY. THE ENROLLMENT FOR THIS STUDY HAS SPANNED SEVERAL YEARS BECAUSE OF THE SEASONALITY OF RSV. RECENTLY PFIZER SUBMITTED THEIR RESULTS TO THE FDA AND AWAIT FDA APPROVAL FOR THIS NOVEL THERAPY. WE CONTINUE TO PARTICIPATE IN THIS TRAIL SINCE THE MATERNAL AND FETAL OUTCOME EXTENDS 24 MONTHS PAST DELIVERY.2. GSK ALSO INITIATED ITS OWN RSV VACCINE TRIAL IN 2021. THE PROPRIETRY FORMULATION IS DIFFERENT, BUT THE BASIC CONSTRUCT OF THE PHASE III, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLEDTRIAL IS SIMILAR. THIS INTERNATIONL TRIAL WAS DESIGNED TO ESTABLISH THE EFFICACY OF A SINGLE DOSE OF UNADJUVANTED RSV MATERNAL VACCINE, ADMINISTERED IM TO PREGNANT WOMEN 18 TO 49 YEARS OF AGE, FOR PREVENTION OF RSV ASSOCIATED LRTI IN THEIR INFANTS UP TO 6 MONTHS OF AGE.3. WHILE WOMB REMAINS COMMITTED TO BREAST FEEDING, WE RECOGNIZE THAT THEIR ARE MANY WOMEN WHO ARE EITHER INCAPABLE OR UNABLE TO BREAST FEED THEIR CHILDREN. THESE WOMEN NEED THE BEST ALTERNATIVE TO BREAST MILK. FOR SOME DONOR BREAST MILK IS THE BEST OPTION, BUT IMPROVED FORMMULAS REMAIN AN IMPORTANT NUTRIONAL OPTION. WOMB IS CURRENTLY PARTICIPATING IN MULTI CENTER MEDICAL DATA COLLECTION IN SUBJECTS PREVIOUSLY ENROLLED IN BY HEART PROTOCOL SS-101-18 BYHEART NEW INFANT FORMULA BH101184. COOK STUDY: RCT COMPARING THE CRB WITH PITOCIN TO PITOCIN ALONE INPREMATURE RUPTURE OF MEMBRANES (PROM) PATIENTS WITH AN UNFAVORABLECERVIX WAS COMPLETED THIS YEAR AND DATA ANALYSIS IS ONGOING. WE EXPECTTO PRESENT THE RESULTS AT THE ANNUAL SMFM MEETING IN 2021.5. ACTIM PARTUS TEST: IS A STUDY DESIGNED TO EVALUATE A NEW DIAGNOSTICTECHNOLOGY TO DETECT PRETERM LABOR AT AN EARLY STAGE WHERE IT MIGHT BETREATED AVOIDING THE SERIOUS CONSEQUENCES OF A PRETERM BIRTH (PTB).THIS STUDY WAS ALSO COMPLETED AND IS UNDER REVIEW BY THE FDA.6. NOVAVAX HAS BEEN WORKING WITH THE WHO/GATES FOUNDATION TO DEVELOP A RSV VACCINE: A PHASE 3, RANDOMIZED, OBSERVER-BLIND,PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THEIMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) FNANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTS. STUDY ENROLLMENT WAS ALSO COMPLETED THIS YEAR, BUT LONG-TERM OUTCOMES ARE STILL BEING COLLECTED.7. WOMB PLACES A PREMIUM ON BREAST FEEDING AND SUPPORTING WOMEN IN THATGOAL BUT WE ALSO RECOGNIZE FOR A VARIETY OF REASONS THERE IS ASIGNIFICANT NUMBER OF WOMEN WHO ARE UNABLE OR UNWILLING TO BREAST FEED.THEIR CHILDREN DESERVE THE BEST NUTRITIONAL OPTION AND THOSE CHOICESCAN ONLY BE DETERMINED WITH ONGOING RESEARCH IN THIS AREA. WOMBCONTINUES TO PARTICIPATE IN SEVERAL ABBOTT FORMULA STUDIES DESIGNED TOIMPROVE THE NUTRITIONAL CHARACTERISTICS OF THEIR FORMULAS FOR SPECIFICNEONATAL POPULATIONS. THE STUDIES ARE DESIGNED TO TEST NEW MILK-BASEDFORMULAS FORTIFIED WITH SPECIFIC SUPPLEMENTS TO MEET SPECIFIC NEEDS OFTERM AND PRETERM INFANTS FOR WHOM BREAST FEEDING IS NOT AN OPTION. THESTUDY IS LOOKING AT MULTIPLE MARKERS FOR NUTRITION, GI TOLERATION ANDGROWTH.8. COMMON SENSE HAS DEVELOPED AN INNOVATIVE APPROACH TO DIAGNOSEPRETERM RUPTURE OF MEMBRANES THAT MIGHT ULTIMATELY PERMIT MANY WOMEN TOBETTER EVALUATE THEIR STATUS PRIOR TO PRESENTING TO THE HOSPITAL. THEPURPOSE OF THIS STUDY WAS TO COMPARE THIS NEW TECHNOLOGY WITH THECURRENT STANDARD OF CARE. THIS STUDY HAS BEEN CONCLUDED AND THE RESULTSARE UNDER REVIEW BY THE FDA.9. WOMB WAS ONE OF THE USA SITES THAT PARTICIPATED IN THE PROLONGTRIAL. USA ENROLLMENT WAS SUSPENDED SEVERAL YEARS AGO BUT THEINTERNATIONAL ENROLLMENT WAS COMPLETED IN 2018, AND THE STUDY RESULTSWERE ANALYZED AND PUBLISHED JUST PRIOR TO THEIR PRESENTATION TO THE FDA IN OCTOBER 2019.