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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Birth; Preterm Labor
• Intervention / Treatment: Other: Multimodal intervention strategy

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.

• Study Type: Interventional
• Enrollment (Estimated): 6500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachna Kumar, MD; Phone Number: 380-223-8986; Email: rachna.kumar@carelon.com
• Study Contact Backup: Name: Adrienne Bodner; Email: adrienne.bodner@carelon.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • UCSD
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale
  • Delaware
    • Newark, Delaware, United States, 19713
      • Delaware/Christiana Care
  • Florida
    • Panama City, Florida, United States, 19801
      • Emerald Coast
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky HealthCare
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner
    • Shreveport, Louisiana, United States, 71101
      • LSU
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • High Risk Pregnancy Center
  • New York
    • New York, New York, United States, 10029
      • Mt Sinai
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Ohio Health
  • Texas
    • Galveston, Texas, United States, 77555-0587
      • UTMB
    • Houston, Texas, United States, 77030
      • Baylor
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health Care Services
    • Richmond, Virginia, United States, 23235
      • VPFW
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • MCW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTB Prevention; 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.	Other: Multimodal intervention strategy; 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
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal morbidity/mortality	Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.	Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.
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.	Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through initial neonate discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days.
Increase gestation	Increase in duration of gestation in the PTB Prevention arm versus the Control arm.	Gestational age at delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in occurrence of one or more major neonatal morbidities	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.	3 year infant follow-up
Cost reduction of neonatal hospitalizations for all admissions	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.	Birth up to neonatal discharge, assessed up to 180 days
Cost reduction of neonatal hospitalizations for NICU admissions	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.	Birth up to neonatal discharge, assessed up to 180 days
Cost reduction of neonatal hospitalizations for PTB admissions	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.	Birth up to neonatal discharge, assessed up to 180 days
Cost reduction of neonatal hospitalizations for PTB admissions after sPTB	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.	Birth up to neonatal discharge, assessed up to 180 days
Reduction in rate of preterm birth <32 weeks gestation	Reduction in the rate of preterm birth <32 weeks of gestation in the PTB Prevention arm versus the Control arm.	Delivery
Reduction in rate of preterm birth <35 weeks gestation	Reduction in the rate of preterm birth <35 weeks of gestation in the PTB Prevention arm versus the Control arm	Delivery
Reduction in rate of preterm birth <37 weeks gestation	Reduction in the rate of preterm birth <37 weeks of gestation in the PTB Prevention arm versus the Control arm.	Delivery
Reduction in rate of preterm birth <32 weeks gestation after sPTB	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.	Delivery
Reduction in rate of preterm birth <35 weeks gestation after sPTB	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.	Delivery
Reduction in rate of preterm birth <37 weeks gestation after sPTB	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.	Delivery
NICU days reduction/NICU admissions <37 weeks	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
NICU days reduction/NICU admissions of sPTB neonates with NICU admission	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
NICU days reduction/NICU admissions of all preterm neonates	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
NICU days reduction/NICU admissions of sPTB neonates	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Preterm neonatal hospital stay reduction	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Preterm neonatal hospital stay reduction for sPTB	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of life
Neonatal hospital and NICU stay reduction after readmission for all admissions	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.	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
Neonatal hospital and NICU stay reduction after readmission for NICU admissions	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.	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
Neonatal hospital and NICU stay reduction after readmission for PTB admissions	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.	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
Neonatal hospital and NICU stay reduction after readmission for sPTB admissions	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.	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
Hospital readmission cost reduction for all admissions	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.	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
Hospital readmission cost reduction for NICU admissions	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.	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
Hospital readmission cost reduction for PTB admissions	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.	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
Hospital readmission cost reduction for sPTB admissions	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.	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
Hospital readmission cost reduction for all admissions 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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Hospital readmission cost reduction within first year of life for NICU admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Hospital readmission cost reduction within first year of life for PTB admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Hospital readmission cost reduction within first year of life for sPTB admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of life
Hospital readmission cost reduction within first three years of life for all admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Hospital readmission cost reduction within first three years of life for NICU admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Hospital readmission cost reduction within first three years of life for PTB admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
Hospital readmission cost reduction within first three years of life for sPTB admissions	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.	From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of life
NICU admission rate reduction	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.	Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days
Neonatal morbidity and mortality index observation	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.	Within one year of primary analysis
Neonatal hospital length of stay observation	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.	Within one year of primary analysis
NICU length of stay observation	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.	Within one year of primary analysis
Duration of gestation observation	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.	Within one year of primary analysis
Major neonatal morbidities observation	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.	Within one year of primary analysis
NICU length of stay amongst preterm neonates observation	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.	Within one year of primary analysis
Hospital length of stay amongst preterm neonates observation	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.	Within one year of primary analysis
Preterm birth rate observation	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.	Within one year of primary analysis
Neonatal hospitalization cost observation	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.	Within one year of primary analysis
Preterm neonatal hospitalization observation	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.	Within one year of primary analysis
Intervention protocol observation/neonatal morbidity and mortality index	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.	Within one year of primary analysis
Intervention protocol observation/length of neonatal hospital stay	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.	Within one year of primary analysis
Intervention protocol observation/length of NICU stay	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.	Within one year of primary analysis
Intervention protocol observation/duration of gestation	Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the secondary endpoint of duration of gestation.	Within one year of primary analysis
Intervention protocol observation/major neonatal morbidities	Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the MNM and exploratory endpoint.	Within one year of primary analysis
Intervention protocol observation/length of NICU stay amongst preterm neonates	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.	Within one year of primary analysis
Intervention protocol observation/length of hospital stay amongst preterm neonates	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.	Within one year of primary analysis
Intervention protocol observation/preterm birth rate	Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of preterm birth rate.	Within one year of primary analysis
Intervention protocol observation/neonatal hospitalization	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.	Within one year of primary analysis
Intervention protocol observation/neonatal hospitalization amongst preterm neonates	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.	Within one year of primary analysis
COVID-19 primary	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.	Within one year of primary analysis
COVID-19 secondary	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.	Within one year of primary analysis
COVID-19 exploratory	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.	Within one year of primary analysis
Anxiety - Generalized Anxiety Disorder 7-item (GAD-7)	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	Within one year of primary analysis
Anxiety - Perinatal Anxiety Screening Scale (PASS)	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	Within one year of primary analysis

Collaborators and Investigators

• Sponsor: Sera Prognostics, Inc.
• Collaborators: High Risk Pregnancy Center, Las Vegas, Nevada
• Investigators: Principal Investigator: Brian Iriye, MD, High Risk Pregnancy Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: preterm; NICU; neonate; neonatal
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: SP019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No