Preterm LaborPRIMENCT04301518
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
A study testing Multimodal intervention strategy in people with Preterm Labor and Preterm Birth, run by Sera Prognostics, Inc. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Preterm Birth
- What is being tested?
- Multimodal intervention strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,500 participants
- Where
- 18 sitesUnited States
- Study dates
- 6 Nov 2020to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 26Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health
Columbus, Ohio, 43214
Inova Health Care Services
Falls Church, Virginia, 22042
UTMB
Galveston, Texas, 77555-0587
High Risk Pregnancy Center
Las Vegas, Nevada, 89106
University of Kentucky Healthcare
Lexington, Kentucky, 40536
MCW
Milwaukee, Wisconsin, 53226
Yale
New Haven, Connecticut, 06519
Ochsner
New Orleans, Louisiana, 70115
Mt Sinai
New York, New York, 10029
Delaware/Christiana Care
Newark, Delaware, 19713
Emerald Coast
Panama City, Florida, 19801
VPFW
Richmond, Virginia, 23235
Beaumont Hospital
Royal Oak, Michigan, 48073
UCSD
San Diego, California, 92121
LSU
Shreveport, Louisiana, 71101
About this study
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.
Read the 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.
- Conditions
- Preterm Labor, Preterm Birth
- Being tested
- Multimodal intervention strategy
- Keywords
- neonate, NICU, neonatal, preterm
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention strategyOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| PTB Prevention | Experimental | 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. Receives: Other: Multimodal intervention strategy |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal morbidity/mortality
Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.
Measured: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.
Length of neonatal hospital stay
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.
Measured: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.
Secondary outcomes (2)
Length of NICU hospital stay for neonates reduction
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.
Measured: Through initial neonate discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days.
Increase gestation
Increase in duration of gestation in the PTB Prevention arm versus the Control arm.
Measured: Gestational age at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start6 Nov 2020
- Primary completion6 Dec 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sera Prognostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- High Risk Pregnancy Center, Las Vegas, Nevada
- Responsible party
- Sponsor
- Investigators
- Brian Iriye, MD, Principal investigator, High Risk Pregnancy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301518
- Sponsor's protocol ID
- SP019
- Acronym
- PRIME
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iriye BK, O'Brien JM, Ennen CS, Barrilleaux PS, Berkin JA, Palatnik A, Son M, Gyamfi-Bannerman C, McDonnold M, Markenson GR, Sciscione AC, Biggio JR, Wolf S, Sullivan SA, Walker M, Shahbaba B, Godt J, Pound SP. Neonatal impact of maternal biomarker screening for risk of preterm birth with targeted interventions (PRIME): A multicenter, randomized, controlled trial. Pregnancy (Hoboken). 2026 Jan 6;2(1):e70202. doi: 10.1002/pmf2.70202. eCollection 2026 Jan.
PubMed 42597049
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
- ClinicalTrials.gov ID
- NCT04301518
- Acronym / sponsor ID
- PRIME / SP019
- Conditions
- Preterm Labor, Preterm Birth
- Keywords
- neonate, NICU, neonatal, preterm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Sera Prognostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- High Risk Pregnancy Center, Las Vegas, Nevada
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PTB Prevention | Experimental | Other: Multimodal intervention strategyApproximately 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | PTB Prevention |
Primary outcome
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.
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.
2 secondary outcomes
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.
Increase gestation
Time frame: Gestational age at delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 42597049Iriye BK, O'Brien JM, Ennen CS, Barrilleaux PS, Berkin JA, Palatnik A, Son M, Gyamfi-Bannerman C, McDonnold M, Markenson GR, Sciscione AC, Biggio JR, Wolf S, Sullivan SA, Walker M, Shahbaba B, Godt J, Pound SP. Neonatal impact of maternal biomarker screening for risk of preterm birth with targeted interventions (PRIME): A multicenter, randomized, controlled trial. Pregnancy (Hoboken). 2026 Jan 6;2(1):e70202. doi: 10.1002/pmf2.70202. eCollection 2026 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Iriye, MD principal investigator
High Risk Pregnancy Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention strategy in people with Preterm Labor and Preterm Birth, run by Sera Prognostics, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal morbidity/mortality (time frame: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.