Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Preterm Labor
- Sponsor
- Sera Prognostics, Inc.
- Enrollment
- 6500
- Locations
- 18
- Primary Endpoint
- Neonatal morbidity/mortality
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)