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Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (PRIME)

Primary Purpose

Preterm Labor, Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimodal intervention strategy
Sponsored by
Sera Prognostics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor focused on measuring neonate, NICU, neonatal, preterm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria

  1. Subject is 18 years of age or older
  2. Subject is willing and able to provide informed consent and comply with intervention if applicable
  3. Subject gestational age is currently within 18 0/7 and 20 6/7 weeks using best estimated due date
  4. This is a singleton intrauterine pregnancy
  5. Subject has no signs and/or symptoms of preterm labor and has intact membranes
  6. Subject has had a 2nd trimester anatomic ultrasound, including evaluation of cervical length, completed by the date of enrollment, but no earlier than 18
  7. In the opinion of the Investigator, the subject's delivery data will be accessible within 20 business days from delivery, and neonatal data will be available for data collection purposes within 20 business days from discharge

Exclusion Criteria:

  1. Subject has had a prior spontaneous preterm delivery (gestational age at birth less than 37 0/7 weeks gestation)
  2. Subject has cervical length less than 25 millimeters (mm) on 2nd trimester transvaginal ultrasound at time of enrollment
  3. Subject has taken progesterone or progesterone-derivative medication after 13 6/7 weeks gestation
  4. Singleton gestation reduced from an original multiple gestation via embryonic reduction or vanishing twin
  5. There is a known major fetal anomaly or chromosomal/ genetic abnormality
  6. Placenta accreta spectrum disorder (accreta/ increta/ percreta)
  7. Placenta covers the internal os by more than 2.5 centimeters (cm) at time of 2nd trimester anatomic ultrasound (18 0/7 and 20 6/7 weeks gestation)
  8. The subject has experienced vaginal bleeding after 13 6/7 weeks gestation
  9. One or more of the following uterine risk factors are present: fibroids > 5.0cm, uterine malformation, history of classical cesarean section, history of prior uterine surgery with trans-myometrial penetration (excludes low transverse cesarean section)
  10. The subject has a planned cesarean section or induction of labor prior to 370/7 weeks gestation
  11. The subject had a cerclage or pessary placed prior to enrollment window in the current pregnancy
  12. The subject has received enoxaparin, heparin, heparin sodium or other low molecular weight heparin since last menstrual period
  13. Subject has current diagnosis of polyhydramnios
  14. Subject has known use of illicit drugs in the current pregnancy, including cocaine, methamphetamine, and/or opioid use disorder in the current pregnancy
  15. Subject is allergic to aspirin or has experienced gastrointestinal bleeding associated with use
  16. Subject is allergic to peanuts and/or peanut oil used in exogenous progesterone formulation
  17. Subject is participating in any other interventional research studies during the current pregnancy
  18. Subject has tested positive for COVID-19 via an FDA-authorized diagnostic test for SARS-CoV-2 within the ten days prior to PreTRM® sample collection
  19. Subject has been evaluated for COVID-19 salient symptoms per the American College of Obstetrics and Gynecology/ Society for Maternal Fetal Medicine (ACOG/SMFM) "Outpatient Assessment and Management for Pregnant Women with Suspected or Confirmed Novel Coronavirus (COVID-19)" in an emergency room (ER) or hospital setting since the last menstrual period (LMP) date.
  20. Subject has a chronic medical disease(s) which require intensive medical surveillance and may increase the risk of preterm delivery to include:

    • Lupus
    • Chronic lung diseases on oxygen replacement
    • Cardiac disease with high risk of maternal mortality, including Marfan syndrome with dilated aortic root and significant pulmonary hypertension
    • Neuromuscular diseases at risk for pulmonary insufficiency (e.g. myotonic dystrophy)
    • Renal failure on dialysis
    • Uncontrolled or poorly controlled hyperthyroidism

Sites / Locations

  • UCSDRecruiting
  • YaleRecruiting
  • Emerald CoastRecruiting
  • University of Kentucky HealthcareRecruiting
  • OchsnerRecruiting
  • LSURecruiting
  • Gabriela MateoRecruiting
  • Beaumont HospitalRecruiting
  • High Risk Pregnancy CenterRecruiting
  • Mt SinaiRecruiting
  • Cleveland Clinic
  • Ohio Health
  • UTMB
  • Baylor
  • Katie Glosson
  • University of VirginiaRecruiting
  • Inova Health Care ServicesRecruiting
  • VPFWRecruiting
  • MCWRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PTB Prevention

Control

Arm Description

Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the PTB Prevention arm will receive the PreTRM® test results. If high risk, women will be consented to take part in the intervention. Those not higher risk will continue on with standard of care.

Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the Control arm will not receive the PreTRM® test results. Control arm subjects will continue on with standard of care.

Outcomes

Primary Outcome Measures

Neonatal morbidity/mortality
Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.
Length of neonatal hospital stay
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.

Secondary Outcome Measures

Length of NICU hospital stay for neonates reduction
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.
Increase gestation
Increase in duration of gestation in the PTB Prevention arm versus the Control arm.

Full Information

First Posted
March 5, 2020
Last Updated
August 24, 2023
Sponsor
Sera Prognostics, Inc.
Collaborators
High Risk Pregnancy Center, Las Vegas, Nevada
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1. Study Identification

Unique Protocol Identification Number
NCT04301518
Brief Title
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
Acronym
PRIME
Official Title
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sera Prognostics, Inc.
Collaborators
High Risk Pregnancy Center, Las Vegas, Nevada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor, Preterm Birth
Keywords
neonate, NICU, neonatal, preterm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To determine the efficacy and safety of a PTB prevention strategy, this study will utilize PreTRM® to prospectively stratify pregnant women with a singleton gestation into categories of risk of PTB and adverse neonatal outcomes. Subjects randomized into the PTB Prevention arm who score at or above the predetermined threshold risk will receive protocol-specified care for the prevention of PTB throughout gestation utilizing defined interventions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTB Prevention
Arm Type
Experimental
Arm Description
Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the PTB Prevention arm will receive the PreTRM® test results. If high risk, women will be consented to take part in the intervention. Those not higher risk will continue on with standard of care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the Control arm will not receive the PreTRM® test results. Control arm subjects will continue on with standard of care.
Intervention Type
Other
Intervention Name(s)
Multimodal intervention strategy
Intervention Description
Once weekly nurse support 200 mg/daily micronized progesterone as vaginal suppository 81 mg/daily low dose aspirin two transvaginal ultrasounds cerclage placement if cervical length is less than or equal to 10 mm prior to 24 weeks gestation
Primary Outcome Measure Information:
Title
Neonatal morbidity/mortality
Description
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.
Title
Length of neonatal hospital stay
Description
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 for all neonates, assessed up to 180 days.
Secondary Outcome Measure Information:
Title
Length of NICU hospital stay for neonates reduction
Description
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
Through initial neonate discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days.
Title
Increase gestation
Description
Increase in duration of gestation in the PTB Prevention arm versus the Control arm.
Time Frame
Gestational age at delivery
Other Pre-specified Outcome Measures:
Title
Reduction in occurrence of one or more major neonatal morbidities
Description
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
3 year infant follow-up
Title
Cost reduction of neonatal hospitalizations for all admissions
Description
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
Title
Cost reduction of neonatal hospitalizations for NICU admissions
Description
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
Title
Cost reduction of neonatal hospitalizations for PTB admissions
Description
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
Title
Cost reduction of neonatal hospitalizations for PTB admissions after sPTB
Description
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
Birth up to neonatal discharge, assessed up to 180 days
Title
Reduction in rate of preterm birth <32 weeks gestation
Description
Reduction in the rate of preterm birth <32 weeks of gestation in the PTB Prevention arm versus the Control arm.
Time Frame
Delivery
Title
Reduction in rate of preterm birth <35 weeks gestation
Description
Reduction in the rate of preterm birth <35 weeks of gestation in the PTB Prevention arm versus the Control arm
Time Frame
Delivery
Title
Reduction in rate of preterm birth <37 weeks gestation
Description
Reduction in the rate of preterm birth <37 weeks of gestation in the PTB Prevention arm versus the Control arm.
Time Frame
Delivery
Title
Reduction in rate of preterm birth <32 weeks gestation after sPTB
Description
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
Title
Reduction in rate of preterm birth <35 weeks gestation after sPTB
Description
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
Title
Reduction in rate of preterm birth <37 weeks gestation after sPTB
Description
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
Delivery
Title
NICU days reduction/NICU admissions <37 weeks
Description
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
Title
NICU days reduction/NICU admissions of sPTB neonates with NICU admission
Description
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
Title
NICU days reduction/NICU admissions of all preterm neonates
Description
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
Title
NICU days reduction/NICU admissions of sPTB neonates
Description
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
Title
Preterm neonatal hospital stay reduction
Description
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
Title
Preterm neonatal hospital stay reduction for sPTB
Description
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
Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Title
Neonatal hospital and NICU stay reduction after readmission for all admissions
Description
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
Title
Neonatal hospital and NICU stay reduction after readmission for NICU admissions
Description
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
Title
Neonatal hospital and NICU stay reduction after readmission for PTB admissions
Description
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
Title
Neonatal hospital and NICU stay reduction after readmission for sPTB admissions
Description
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
Title
Hospital readmission cost reduction for all admissions
Description
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
Title
Hospital readmission cost reduction for NICU admissions
Description
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
Title
Hospital readmission cost reduction for PTB admissions
Description
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
Title
Hospital readmission cost reduction for sPTB admissions
Description
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 180 days of life for those discharged prior to 180 days of life
Title
Hospital readmission cost reduction for all admissions within first year of life
Description
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
Title
Hospital readmission cost reduction within first year of life for NICU admissions
Description
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
Title
Hospital readmission cost reduction within first year of life for PTB admissions
Description
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
Title
Hospital readmission cost reduction within first year of life for sPTB admissions
Description
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 year of life
Title
Hospital readmission cost reduction within first three years of life for all admissions
Description
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
Title
Hospital readmission cost reduction within first three years of life for NICU admissions
Description
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
Title
Hospital readmission cost reduction within first three years of life for PTB admissions
Description
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
Title
Hospital readmission cost reduction within first three years of life for sPTB admissions
Description
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
From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Title
NICU admission rate reduction
Description
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
Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days
Title
Neonatal morbidity and mortality index observation
Description
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
Title
Neonatal hospital length of stay observation
Description
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
Title
NICU length of stay observation
Description
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
Title
Duration of gestation observation
Description
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
Title
Major neonatal morbidities observation
Description
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
Title
NICU length of stay amongst preterm neonates observation
Description
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
Title
Hospital length of stay amongst preterm neonates observation
Description
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
Title
Preterm birth rate observation
Description
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
Title
Neonatal hospitalization cost observation
Description
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
Title
Preterm neonatal hospitalization observation
Description
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
Title
Intervention protocol observation/neonatal morbidity and mortality index
Description
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
Title
Intervention protocol observation/length of neonatal hospital stay
Description
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
Title
Intervention protocol observation/length of NICU stay
Description
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
Title
Intervention protocol observation/duration of gestation
Description
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
Title
Intervention protocol observation/major neonatal morbidities
Description
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
Title
Intervention protocol observation/length of NICU stay amongst preterm neonates
Description
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
Title
Intervention protocol observation/length of hospital stay amongst preterm neonates
Description
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
Title
Intervention protocol observation/preterm birth rate
Description
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
Title
Intervention protocol observation/neonatal hospitalization
Description
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
Title
Intervention protocol observation/neonatal hospitalization amongst preterm neonates
Description
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
Title
COVID-19 primary
Description
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
Title
COVID-19 secondary
Description
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
Title
COVID-19 exploratory
Description
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
Title
Anxiety - Generalized Anxiety Disorder 7-item (GAD-7)
Description
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
Title
Anxiety - Perinatal Anxiety Screening Scale (PASS)
Description
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
Time Frame
Within one year of primary analysis

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Subject is 18 years of age or older Subject is willing and able to provide informed consent and comply with intervention if applicable Subject gestational age is currently within 18 0/7 and 20 6/7 weeks using best estimated due date This is a singleton intrauterine pregnancy Subject has no signs and/or symptoms of preterm labor and has intact membranes Subject has had a 2nd trimester anatomic ultrasound, including evaluation of cervical length, completed by the date of enrollment, but no earlier than 18 In the opinion of the Investigator, the subject's delivery data will be accessible within 20 business days from delivery, and neonatal data will be available for data collection purposes within 20 business days from discharge Exclusion Criteria: Subject has had a prior spontaneous preterm delivery (gestational age at birth less than 37 0/7 weeks gestation) Subject has cervical length less than 25 millimeters (mm) on 2nd trimester transvaginal ultrasound at time of enrollment Subject has taken progesterone or progesterone-derivative medication after 13 6/7 weeks gestation Singleton gestation reduced from an original multiple gestation via embryonic reduction or vanishing twin There is a known major fetal anomaly or chromosomal/ genetic abnormality Placenta accreta spectrum disorder (accreta/ increta/ percreta) Placenta covers the internal os by more than 2.5 centimeters (cm) at time of 2nd trimester anatomic ultrasound (18 0/7 and 20 6/7 weeks gestation) The subject has experienced vaginal bleeding after 13 6/7 weeks gestation One or more of the following uterine risk factors are present: fibroids > 5.0cm, uterine malformation, history of classical cesarean section, history of prior uterine surgery with trans-myometrial penetration (excludes low transverse cesarean section) The subject has a planned cesarean section or induction of labor prior to 370/7 weeks gestation The subject had a cerclage or pessary placed prior to enrollment window in the current pregnancy The subject has received enoxaparin, heparin, heparin sodium or other low molecular weight heparin since last menstrual period Subject has current diagnosis of polyhydramnios Subject has known use of illicit drugs in the current pregnancy, including cocaine, methamphetamine, and/or opioid use disorder in the current pregnancy Subject is allergic to aspirin or has experienced gastrointestinal bleeding associated with use Subject is allergic to peanuts and/or peanut oil used in exogenous progesterone formulation Subject is participating in any other interventional research studies during the current pregnancy Subject has tested positive for COVID-19 via an FDA-authorized diagnostic test for SARS-CoV-2 within the ten days prior to PreTRM® sample collection Subject has been evaluated for COVID-19 salient symptoms per the American College of Obstetrics and Gynecology/ Society for Maternal Fetal Medicine (ACOG/SMFM) "Outpatient Assessment and Management for Pregnant Women with Suspected or Confirmed Novel Coronavirus (COVID-19)" in an emergency room (ER) or hospital setting since the last menstrual period (LMP) date. Subject has a chronic medical disease(s) which require intensive medical surveillance and may increase the risk of preterm delivery to include: Lupus Chronic lung diseases on oxygen replacement Cardiac disease with high risk of maternal mortality, including Marfan syndrome with dilated aortic root and significant pulmonary hypertension Neuromuscular diseases at risk for pulmonary insufficiency (e.g. myotonic dystrophy) Renal failure on dialysis Uncontrolled or poorly controlled hyperthyroidism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachna Kumar, MD
Phone
380-223-8986
Email
rachna.kumar@carelon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adrienne Bodner
Email
adrienne.bodner@carelon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Iriye, MD
Organizational Affiliation
High Risk Pregnancy Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Valentine
Email
hdvalentine@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Gyamfi-Bannerman, MD
Facility Name
Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Leventhal
Phone
203-785-3660
Email
jessica.leventhal@yale.edu
First Name & Middle Initial & Last Name & Degree
Moeun Son, MD
Facility Name
Emerald Coast
City
Panama City
State/Province
Florida
ZIP/Postal Code
19801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Green
Email
lauren.green@floridawomancare.com
First Name & Middle Initial & Last Name & Degree
Samuel Wolf, MD
Facility Name
University of Kentucky Healthcare
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Cockerham-Morris, BSN, BS
Phone
859-629-2015
Email
ctcock2@uky.edu
First Name & Middle Initial & Last Name & Degree
John O'Brien, MD
Facility Name
Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Lovell
Phone
504-897-5882
Email
ellen.lovell@ochsner.org
First Name & Middle Initial & Last Name & Degree
Sarah Geiger
Phone
504-894-2861
Email
sarah.geiger@ochsner.org
First Name & Middle Initial & Last Name & Degree
Joseph Biggio, MD
Facility Name
LSU
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Mcdonnell, RN/MBA
Phone
318-429-2457
Email
michelle.mcdonnell@lsuhs.edu
First Name & Middle Initial & Last Name & Degree
Shannon Phillips, RN
Phone
318-429-2475
Email
shannon.phillips@lsuhs.edu
First Name & Middle Initial & Last Name & Degree
Perry Barrilleaux, MD
Facility Name
Gabriela Mateo
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Mateo
Email
Gabriela.Mateo@bmc.org
First Name & Middle Initial & Last Name & Degree
Glen M Markenson, MD
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Greear
Email
alexis.greear@corewellhealth.org
First Name & Middle Initial & Last Name & Degree
Zeynep Alpay Savasan, MD
Facility Name
High Risk Pregnancy Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Somdahl, RN
Phone
702-382-3200
Email
jsomdahl@hrpregnancy.com
First Name & Middle Initial & Last Name & Degree
Brian Iriye, MD
Facility Name
Mt Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica M Patel
Phone
212-241-8279
Email
monica.patel@mssm.edu
First Name & Middle Initial & Last Name & Degree
Jill Berkin
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Terminated
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Terminated
Facility Name
UTMB
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Glosson
Email
Katie.glosson@bcm.edu
First Name & Middle Initial & Last Name & Degree
Kjersti Aagaard, M.D.
Facility Name
Katie Glosson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Glosson
Email
Katie.glosson@bcm.edu
First Name & Middle Initial & Last Name & Degree
Kjersti Aagaard, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Ennen, MD
Phone
434-924-2500
Email
CE4JD@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Amanda Urban, MS
Phone
434-409-3100
Email
AJR5Y@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Donald Dudley, MD
Facility Name
Inova Health Care Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sneha Kumar
Email
sneha.kumar@inova.org
First Name & Middle Initial & Last Name & Degree
Scott Sullivan
Facility Name
VPFW
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Harvell
Phone
804-715-2169
Email
mph@clinicalresearchrva.com
First Name & Middle Initial & Last Name & Degree
Stephen Pound, MD
Facility Name
MCW
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleanor Saffian
Phone
414-805-6605
Email
esaffian@mcw.edu
First Name & Middle Initial & Last Name & Degree
Anna Palatnik, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

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