Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

Open to females ages 18 years and up

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

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