Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
NCT ID: NCT04301518
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
6500 participants
INTERVENTIONAL
2020-11-06
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
High Risk Pregnancy Center, Las Vegas, Nevada
OTHER
Sera Prognostics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian Iriye, MD
Role: PRINCIPAL_INVESTIGATOR
High Risk Pregnancy Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SP019
Identifier Type: -
Identifier Source: org_study_id