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

• ClinicalTrials.gov Identifier: NCT04301518
• Recruitment Status: Active, not recruiting
• First Posted: March 10, 2020
• Last Update Posted: December 12, 2023
• Sponsor: Sera Prognostics, Inc.
• Collaborator: High Risk Pregnancy Center, Las Vegas, Nevada
• Information provided by (Responsible Party): Sera Prognostics, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Preterm Labor; Preterm Birth	Other: Multimodal intervention strategy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 6500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Prevention
• Official Title: Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
• Actual Study Start Date: November 6, 2020
• Estimated Primary Completion Date: December 30, 2023
• Estimated Study Completion Date: December 30, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Neonatal morbidity/mortality [ 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.
2. Length of neonatal hospital stay [ 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.

Secondary Outcome Measures :

1. Length of NICU hospital stay for neonates reduction [ 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.
2. Increase gestation [ Time Frame: Gestational age at delivery ]
   Increase in duration of gestation in the PTB Prevention arm versus the Control arm.

Other Outcome Measures:

1. Reduction in occurrence of one or more major neonatal morbidities [ 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.
2. Cost reduction of neonatal hospitalizations for all admissions [ 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.
3. Cost reduction of neonatal hospitalizations for NICU admissions [ 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.
4. Cost reduction of neonatal hospitalizations for PTB admissions [ 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.
5. Cost reduction of neonatal hospitalizations for PTB admissions after sPTB [ 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.
6. Reduction in rate of preterm birth <32 weeks gestation [ Time Frame: Delivery ]
   Reduction in the rate of preterm birth <32 weeks of gestation in the PTB Prevention arm versus the Control arm.
7. Reduction in rate of preterm birth <35 weeks gestation [ Time Frame: Delivery ]
   Reduction in the rate of preterm birth <35 weeks of gestation in the PTB Prevention arm versus the Control arm
8. Reduction in rate of preterm birth <37 weeks gestation [ Time Frame: Delivery ]
   Reduction in the rate of preterm birth <37 weeks of gestation in the PTB Prevention arm versus the Control arm.
9. Reduction in rate of preterm birth <32 weeks gestation after sPTB [ 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.
10. Reduction in rate of preterm birth <35 weeks gestation after sPTB [ 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.
11. Reduction in rate of preterm birth <37 weeks gestation after sPTB [ 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.
12. NICU days reduction/NICU admissions <37 weeks [ 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.
13. NICU days reduction/NICU admissions of sPTB neonates with NICU admission [ 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.
14. NICU days reduction/NICU admissions of all preterm neonates [ 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.
15. NICU days reduction/NICU admissions of sPTB neonates [ 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.
16. Preterm neonatal hospital stay reduction [ 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.
17. Preterm neonatal hospital stay reduction for sPTB [ 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.
18. Neonatal hospital and NICU stay reduction after readmission for all admissions [ 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.
19. Neonatal hospital and NICU stay reduction after readmission for NICU admissions [ 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.
20. Neonatal hospital and NICU stay reduction after readmission for PTB admissions [ 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.
21. Neonatal hospital and NICU stay reduction after readmission for sPTB admissions [ 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.
22. Hospital readmission cost reduction for all admissions [ 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.
23. Hospital readmission cost reduction for NICU admissions [ 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.
24. Hospital readmission cost reduction for PTB admissions [ 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.
25. Hospital readmission cost reduction for sPTB admissions [ 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.
26. Hospital readmission cost reduction for all admissions within first year of life [ 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.
27. Hospital readmission cost reduction within first year of life for NICU admissions [ 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.
28. Hospital readmission cost reduction within first year of life for PTB admissions [ 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.
29. Hospital readmission cost reduction within first year of life for sPTB admissions [ 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.
30. Hospital readmission cost reduction within first three years of life for all admissions [ 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.
31. Hospital readmission cost reduction within first three years of life for NICU admissions [ 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.
32. Hospital readmission cost reduction within first three years of life for PTB admissions [ 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.
33. Hospital readmission cost reduction within first three years of life for sPTB admissions [ 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.
34. NICU admission rate reduction [ 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.
35. Neonatal morbidity and mortality index observation [ 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.
36. Neonatal hospital length of stay observation [ 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.
37. NICU length of stay observation [ 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.
38. Duration of gestation observation [ 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.
39. Major neonatal morbidities observation [ 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.
40. NICU length of stay amongst preterm neonates observation [ 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.
41. Hospital length of stay amongst preterm neonates observation [ 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.
42. Preterm birth rate observation [ 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.
43. Neonatal hospitalization cost observation [ 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.
44. Preterm neonatal hospitalization observation [ 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.
45. Intervention protocol observation/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 composite neonatal morbidity and mortality index.
46. Intervention protocol observation/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 co-primary endpoint of length of neonatal hospital stay.
47. Intervention protocol observation/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 length of NICU stay.
48. Intervention protocol observation/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 secondary endpoint of duration of gestation.
49. Intervention protocol observation/major neonatal morbidities [ 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.
50. Intervention protocol observation/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 NICU stay amongst preterm neonates.
51. Intervention protocol observation/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 length of hospital stay amongst preterm neonates.
52. Intervention protocol observation/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 preterm birth rate.
53. Intervention protocol observation/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.
54. Intervention protocol observation/neonatal hospitalization 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 all-cause cost of neonatal hospitalization amongst preterm neonates.
55. COVID-19 primary [ 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.
56. COVID-19 secondary [ 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.
57. COVID-19 exploratory [ 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.
58. Anxiety - Generalized Anxiety Disorder 7-item (GAD-7) [ 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
59. Anxiety - Perinatal Anxiety Screening Scale (PASS) [ 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

UCSD

San Diego, California, United States, 92121

United States, Connecticut

Yale

New Haven, Connecticut, United States, 06519

United States, Delaware

Delaware/Christiana Care

Newark, Delaware, United States, 19713

United States, Florida

Emerald Coast

Panama City, Florida, United States, 19801

United States, Kentucky

University of Kentucky Healthcare

Lexington, Kentucky, United States, 40536

United States, Louisiana

Ochsner

New Orleans, Louisiana, United States, 70115

LSU

Shreveport, Louisiana, United States, 71101

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

United States, Michigan

Beaumont Hospital

Royal Oak, Michigan, United States, 48073

United States, Nevada

High Risk Pregnancy Center

Las Vegas, Nevada, United States, 89106

United States, New York

Mt Sinai

New York, New York, United States, 10029

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Ohio Health

Columbus, Ohio, United States, 43214

United States, Texas

UTMB

Galveston, Texas, United States, 77555-0587

Baylor

Houston, Texas, United States, 77030

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Inova Health Care Services

Falls Church, Virginia, United States, 22042

VPFW

Richmond, Virginia, United States, 23235

United States, Wisconsin

MCW

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Sera Prognostics, Inc.

High Risk Pregnancy Center, Las Vegas, Nevada

Investigators

• Principal Investigator: Brian Iriye, MD; High Risk Pregnancy Center

More Information

• Responsible Party: Sera Prognostics, Inc.
• ClinicalTrials.gov Identifier: NCT04301518
• Other Study ID Numbers: SP019
• First Posted: March 10, 2020
• Last Update Posted: December 12, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sera Prognostics, Inc.:

neonate; NICU; neonatal; preterm

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases