Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

Running, not enrolling · Not applicable

Conditions studied: Preterm Labor, Preterm Birth

In brief

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.

Key facts

Study ID

NCT04301518

Run by

Sera Prognostics, Inc.

People needed

6500

Starts

2020-11-06

Expected to finish

2026-12-30

Last updated by the study team

2024-12-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD — San Diego, California, United States
• Yale — New Haven, Connecticut, United States
• Delaware/Christiana Care — Newark, Delaware, United States
• Emerald Coast — Panama City, Florida, United States
• University of Kentucky Healthcare — Lexington, Kentucky, United States
• Ochsner — New Orleans, Louisiana, United States
• LSU — Shreveport, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• High Risk Pregnancy Center — Las Vegas, Nevada, United States
• Mt Sinai — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio Health — Columbus, Ohio, United States
• UTMB — Galveston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Health Care Services — Falls Church, Virginia, United States
• VPFW — Richmond, Virginia, United States
• MCW — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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