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Principal Investigator: ALISON G CAHILL
Organization: UNIVERSITY OF PENNSYLVANIA
Fiscal Year: 2024
Award: $665,371
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
PROJECT ABSTRACT
More than one million women undergo labor induction in the U.S. annually and over one-third of inductions end
in cesarean delivery (CD). While many factors contribute to the CD rate, shifting the start of labor induction (e.g.
cervical ripening) from an inpatient to outpatient setting is an intervention that can shape the early course of
labor and significantly reduce the risk of CD. Possible mechanisms for the lower CD rate include improved sleep
and relaxation at home, but also decreased time in the hospital and in turn, a decrease in medical interventions
as well as a decreased exposure to variability in the diagnosis of abnormal labor progress. Based on published
evidence that reduced time in the hospital is associated with reduced interventions, as well as early effectiveness
data from small studies of outpatient Foley, we hypothesize that shifting the first part of the induction process
from hospital to outpatient setting will be a promising and underutilized way to decrease CD rates.
Furthermore, care delivery at home, in the outpatient setting, has been shown to improve healthcare utilization
and cost by decreasing time in the hospital within internal medicine. The COVID-19 pandemic has further
highlighted now as a critical time to think of novel and innovative ways to keep patients out of the hospital. This
will be the first large, multicenter trial on outpatient cervical ripening powered to determine both effectiveness
and safety of outpatient Foley.
We propose a large (2300 women), multicenter, pragmatic, randomized trial to test the central hypothesis that
outpatient cervical ripening with a Foley catheter will 1) decrease the primary CD rate and 2) reduce maternal
and neonatal morbidity. Given the long time-lag between effectiveness studies and widespread implementation,
we will additionally explore barriers and facilitators to implementation to enable rapid uptake and dissemination
of our findings. Through a Type 1 hybrid effectiveness-implementation study, we will pursue the following specific
aims: (1) Determine the effectiveness of outpatient Foley for cervical ripening in reducing the rate of CD among
nulliparous women undergoing labor induction, (2) Determine the effectiveness of outpatient Foley in reducing
maternal and neonatal morbidity and improving patient satisfaction, and (3) To characterize patient, provider,
and organizational implementation determinants relevant to outpatient versus inpatient cervical ripening with a
Foley catheter. Additional analyses will also compare maternal and neonatal resource utilization.
A trial of this size and rigor is critical to changing the standard of care for millions of delivering women.
Of critical importance, even if our primary effectiveness aim is negative, we will be powered to evaluate
secondary effectiveness and safety outcomes, and the primary implementation aim will yield insight into
ways to improve the induction process for thousands of patients through comparison of implementation
determinants and resource utilization between the two arms.
Terms: <Abdominal Delivery><Abnormal placentation><Birth><Bleeding><C section><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Catheters><Cervical Ripening><Cervical Ripenings><Cesarean><Cesarean section><Client satisfaction><Data><Diagnosis><Diagnostic><Dissemination and Implementation><Effectiveness><Endometritis><Exposure to><Future><Gestation><Goals><Health Care Utilization><Health system><Hemorrhage><Home><Hospitals><Hypoglycemia><Induced Labor><Infection><Inpatients><Internal Medicine><Intervention><Intervention Strategies><Interview><Label><Labor Dystocia><Measures><Medical><Meta-Analysis><Methods><Morbidity><Morbidity - disease rate><Multi-center trial><Multicenter Trials><Neonatal><Nulliparas><Nulliparity><Nulliparous><Nurses><Out-patients><Outpatients><Parturition><Patient Satisfaction><Patients><Perception><Pregnancy><Procedures><Process><Provider><Public Health><Publishing><Randomization trial><Randomized><Relaxation><Research Resources><Resources><Respiratory distress><Risk><Risk Reduction><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety><Sepsis><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Shapes><Survey Instrument><Surveys><Testing><Time><Transfusion><Uterine Dystocia><Visit><Woman><Wound Infection><arm><assess effectiveness><blood infection><blood loss><bloodstream infection><care delivery><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><determine effectiveness><effectiveness and implementation trial><effectiveness assessment><effectiveness evaluation><effectiveness outcome><effectiveness study><effectiveness-related outcomes><effectiveness/implementation hybrid study><effectiveness/implementation hybrid trial><effectiveness/implementation study><effectiveness/implementation trial><evaluate effectiveness><examine effectiveness><facilitators to implementation><health care service use><health care service utilization><healthcare service use><healthcare service utilization><healthcare utilization><homes><hospital re-admission><hospital readmission><hypoglycemic><hypoglycemic episodes><hypoxic ischemic encephalopathy><implementation determinants><implementation facilitators><implementation factors><improved><improvement on sleep><infected wound><innovate><innovation><innovative><insight><interventional strategy><labor induction><maternal morbidity><maternal outcome><maternal risk><mother outcome><neonatal HIE><neonatal hypoxia-ischemia><neonatal hypoxic-ischemic brain injury><neonatal hypoxic-ischemic encephalopathy><neonatal morbidity><newborn morbidity><novel><nurse><parous><pragmatic randomized trial><randomisation><randomization><randomized trial><randomly assigned><re-admission><re-hospitalization><readmission><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><rehospitalization><risk-reducing><safety outcomes><satisfaction><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><sleep improvement><standard of care><uptake><venous thromboembolism>