NCT Number: NCT04301518
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Not applicable
UCSD, San Diego, California, United States
Prospective subjects will be randomized to the PTB prevention strategy (PTB Prevention arm) or to standard of care management (Control arm). Subjects randomized to the preterm birth prevention strategy will receive either routine standard of care pregnancy management or a multimodal intervention protocol reserved for higher risk pregnancies based on the results of a commercially-available laboratory developed test, PreTRM® (Sera Prognostics, Inc). The intervention protocol utilizes well-established high-risk pregnancy interventions to improve maternal and neonatal health outcomes.
After enrollment, all subjects will have a blood sample collected once between 18 0/7 weeks and 20 6/7 weeks (126-146 days) of pregnancy. Subjects will be randomized 1:1 to participate in the preterm birth prevention strategy arm or standard of care for pregnancy (Control) arm. Subjects randomized to the Control arm will not receive PreTRM® test results. Subjects randomized to the PTB Prevention arm will receive the results of the PreTRM® test. Results will be reported to the subject, the study Investigator, and the subject's primary pregnancy care provider as "higher risk" of prematurity (≥15%) or "not higher" risk. Subjects with results less than 15% risk (Not Higher Risk Group) by the PreTRM® test will receive standard of care for the duration of pregnancy through hospital discharge. Subjects with results at 15% risk of preterm delivery or greater (Higher Risk Group, equivalent to 2.0-fold the general population risk) by the PreTRM® test will complete a second consenting process to receive a prespecified intervention protocol directed toward reducing risk of adverse pregnancy outcomes inclusive of neonatal morbidity and mortality. All subjects will be followed through the duration of the pregnancy and delivery, and their neonates until initial hospital discharge to assess the course of pregnancy, labor, and any related maternal or fetal complications.
Birth outcomes will be obtained, and liveborn neonates followed through hospital discharge. Readmission of infants will be assessed at 180 days, 1 year and 3 years of life using the HealthCore Integrated Research Database to evaluate longer-term outcomes and costs associated with preterm delivery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.
Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.
Reduction in length of neonatal hospital stay for admissions from time of birth up to initial neonatal hospital discharge home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonate discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days.
Reduction in all days spent in the neonatal intensive care unit (NICU) for neonates from time of birth up to discharge home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Time frame: Gestational age at delivery
Increase in duration of gestation in the PTB Prevention arm versus the Control arm.
Time frame: 3 year infant follow-up
Reduction in occurrence of one or more major neonatal morbidities (MNM) with high likelihood of major chronic illness - cystic periventricular leukomalacia, grade 3 and 4 intraventricular hemorrhage, grade 3 or higher retinopathy of prematurity and/or bronchopulmonary dysplasia - in the PTB Prevention arm versus the Control arm.
Time frame: Birth up to neonatal discharge, assessed up to 180 days
Reduction in all-cause cost of neonatal hospitalizations for all admissions from time of birth up to neonatal discharge in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: Birth up to neonatal discharge, assessed up to 180 days
Reduction in all-cause cost of neonatal hospitalizations, for NICU admissions from time of birth up to neonatal discharge in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: Birth up to neonatal discharge, assessed up to 180 days
Reduction in all-cause cost of neonatal hospitalizations, for PTB admissions from time of birth up to neonatal discharge in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: Birth up to neonatal discharge, assessed up to 180 days
Reduction in all-cause cost of neonatal hospitalizations from time of birth up to neonatal discharge for admissions of preterm births after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: Delivery
Reduction in the rate of preterm birth <32 weeks of gestation in the PTB Prevention arm versus the Control arm.
Time frame: Delivery
Reduction in the rate of preterm birth <35 weeks of gestation in the PTB Prevention arm versus the Control arm
Time frame: Delivery
Reduction in the rate of preterm birth <37 weeks of gestation in the PTB Prevention arm versus the Control arm.
Time frame: Delivery
Reduction in the rate of preterm birth <32 weeks of gestation after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Time frame: Delivery
Reduction in the rate of preterm birth <35 weeks of gestation after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Time frame: Delivery
Reduction in the rate of preterm birth <37 weeks of gestation after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Reduction in all days spent in the NICU for all NICU admissions of preterm neonates (<37 weeks, only PTB with NICU admission) from birth up to neonatal discharge to home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Reduction in all days spent in the NICU for all NICU admissions of spontaneous preterm neonates (only sPTB with NICU admission) from birth up to neonatal discharge to home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Reduction in all days spent in the NICU from birth up to neonatal discharge to home or neonatal death, whichever occurs first, for all preterm neonates (independent of NICU admission including zero-length stays for those not admitted), in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Reduction in all days spent in the NICU from birth up to neonatal discharge to home or neonatal death, whichever occurs first, for all sPTB neonates (independent of NICU admission including zero-length stays for those not admitted), in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Reduction in length of neonatal hospital stay from birth up to neonatal discharge home or neonatal death, whichever occurs first, for all preterm neonates (<37 weeks, all PTB), in the PTB Prevention arm versus the Control arm.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Reduction in length of neonatal hospital stay from birth up to neonatal discharge home or neonatal death, whichever occurs first, for all preterm neonates (<37 weeks, all sPTB), in the PTB Prevention arm versus the Control arm.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for all admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for NICU admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for PTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for sPTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for all admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for NICU admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for PTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for sPTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for all admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for NICU admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for PTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for sPTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for all admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for NICU admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for PTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for sPTB admissions, in the PTB Prevention arm versus the Control arm in the Anthem beneficiary subset of the study population.
Time frame: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days
Reduction in NICU admission rates in the immediate neonatal period prior to initial discharge home or neonatal death, whichever occurs first, in the PTB Prevention arm versus Control arm.
Time frame: Within one year of primary analysis
Observation of the dependence of the composite neonatal morbidity and mortality index co-primary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the length of neonatal hospital stay co-primary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the NICU length of stay secondary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the duration of gestation secondary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the MNM exploratory endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the exploratory endpoint of dependence of NICU length of stay amongst preterm neonates on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the exploratory endpoint of dependence of hospital length of stay amongst preterm neonates on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the preterm birth rate exploratory endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the exploratory endpoint of all-cause cost of neonatal hospitalization on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the dependence of the exploratory endpoint of all-cause cost of neonatal hospitalization amongst preterm neonates on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the co-primary endpoint of composite neonatal morbidity and mortality index.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the co-primary endpoint of length of neonatal hospital stay.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the, secondary endpoint of length of NICU stay.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the secondary endpoint of duration of gestation.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the MNM and exploratory endpoint.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of length of NICU stay amongst preterm neonates.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of length of hospital stay amongst preterm neonates.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of preterm birth rate.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of all-cause cost of neonatal hospitalization.
Time frame: Within one year of primary analysis
Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of all-cause cost of neonatal hospitalization amongst preterm neonates.
Time frame: Within one year of primary analysis
Observation of the effect on primary endpoints of SARS-CoV-2 positivity or COVID-19 salient symptoms requiring evaluation in an ER or hospital setting after enrollment.
Time frame: Within one year of primary analysis
Observation of the effect on secondary endpoints of SARS-CoV-2 positivity or COVID-19 salient symptoms requiring evaluation in an ER or hospital setting after enrollment.
Time frame: Within one year of primary analysis
Observation of the effect on exploratory endpoints of SARS-CoV-2 positivity or COVID-19 salient symptoms requiring evaluation in an ER or hospital setting after enrollment.
Time frame: Within one year of primary analysis
Change (mean difference) in Generalized Anxiety Disorder 7-item (GAD-7) scores at enrollment and 6-weeks post-enrollment in a subset of subjects. Scale range 0 - 21, higher values correlate with higher anxiety
Time frame: Within one year of primary analysis
Change (mean difference) in perinatal Anxiety Screening Scale (PASS) scores at enrollment and 6-weeks post-enrollment in a subset of subjects. Scale range 0 - 93, higher values correlate with higher anxiety
Sera Prognostics, Inc.
Industry
Acronym: PRIME
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