Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

NCT04301518 | Active Not Recruiting DMC

• 1 other identifier: SP019
• Study Type: interventional
• Target: 6,500
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Preterm Labor; Preterm Birth

Keywords

neonate; NICU; neonatal; preterm

Outcome Measures

Primary Outcomes (2)

• Neonatal morbidity/mortality

  Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.

  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.

  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

  Through initial neonate discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days.

• Increase gestation

  Gestational age at delivery

Other Outcomes (59)

• Reduction in occurrence of one or more major neonatal morbidities

  3 year infant follow-up

• Cost reduction of neonatal hospitalizations for all admissions

  Birth up to neonatal discharge, assessed up to 180 days

• Cost reduction of neonatal hospitalizations for NICU admissions

  Birth up to neonatal discharge, assessed up to 180 days

Study Arms (2)

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.

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.

Interventions

Multimodal intervention strategy OTHER

* 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

PTB Prevention

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sera Prognostics, Inc.: lead
• High Risk Pregnancy Center, Las Vegas, Nevada: collaborator

Study Sites (18)

UCSD

San Diego, California, 92121, United States

Location

Yale

New Haven, Connecticut, 06519, United States

Location

Delaware/Christiana Care

Newark, Delaware, 19713, United States

Location

Emerald Coast

Panama City, Florida, 19801, United States

Location

University of Kentucky Healthcare

Lexington, Kentucky, 40536, United States

Location

Ochsner

New Orleans, Louisiana, 70115, United States

Location

LSU

Shreveport, Louisiana, 71101, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

High Risk Pregnancy Center

Las Vegas, Nevada, 89106, United States

Location

Mt Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health

Columbus, Ohio, 43214, United States

Location

UTMB

Galveston, Texas, 77555-0587, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

VPFW

Richmond, Virginia, 23235, United States

Location

MCW

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Brian Iriye, MD

  High Risk Pregnancy Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: November 6, 2020
• Primary Completion: December 6, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)