Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (PRIME)
Preterm Labor, Preterm Birth
About this trial
This is an interventional prevention trial for Preterm Labor focused on measuring neonate, NICU, neonatal, preterm
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
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
Experimental
No Intervention
PTB Prevention
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 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.