Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)

Study Overview
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Brief Summary
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This research study is being done to find out whether a screening blood test can help identify women with an increased risk of preterm birth.

Detailed Description
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Preterm birth (PTB) remains the leading cause of neonatal mortality and long-term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Nonetheless, the majority of women who are at risk are not identified using current screening methods. Women who are 18 years or older, with a singleton pregnancy between 19 5/7 weeks and 20 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment and no history of prior preterm birth (delivery between 16 0/7 weeks and 37 6/7 weeks) will be invited to participate. Women who enroll will be randomized to screening and intervention for those at high risk of PTB or no screening and standard care. All participants will undergo sample collection, but the samples from the group randomized to no screening' will not be analyzed until the end of the study (post-delivery of all neonates). Women randomized to the intervention group will be screened using the PreTRM® test (Sera Prognostics, Inc.) at a large tertiary care center. Predicated upon the degree of risk, women will be treated according to a pre-specified algorithm. The outcomes of these women will be compared to a control group of women who do not receive screening at the same tertiary care center.

Official Title
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Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial

Conditions
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Preterm Birth

Intervention / Treatment
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* Diagnostic Test: PreTRM test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject is greater than or equal to 18 years of age AND Uncomplicated singleton intrauterine pregnancy less than 21 weeks estimated gestation AND No medical contraindications to continuing pregnancy AND No previous classical cesarean section AND No known uterine anomaly AND No history of cervical conization AND No plan for cesarean section prior to 37 0/7 weeks gestation AND No plan for induction of labor prior to 37 0/7 weeks gestation AND Subject has no history of spontaneous preterm delivery AND No prior PPROM less than 34 weeks AND Subject has no signs and/or symptoms of preterm labor AND Subject has intact membranes AND Subject has not received a blood transfusion during the current pregnancy. Exclusion Criteria Subjects who have taken or plan to take progesterone beyond 13 6/7 weeks gestation prior to study enrollment OR Any other medical conditions that put subject at increased risk of preterm birth in the judgment of the site investigator OR The subject has a planned cerclage placement for the current pregnancy OR Previously identified short cervix (less than 2.5 cm by transvaginal ultrasound) prior to enrollment OR Known major structural fetal anomalies that may shorten pregnancy (e.g., anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia) OR Known fetal genetic anomalies that are incompatible with life (e.g., trisomy 13 or trisomy 18) OR The subject has known elevated bilirubin levels (hyperbilirubinemia) OR The subject has taken or plans to take any of the following medications after the first day of the last menstrual period: Enoxaparin, heparin, heparin sodium, low molecular weight heparin, low dose aspirin OR A history of allergic reaction to aspirin or 17-OHPC injections OR Subject does not plan to deliver at an Intermountain Healthcare hospital.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Diagnostic Test: PreTRM test<br>* Blood test to determine risk of preterm birth<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of spontaneous preterm birth |  | Before 37 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery |  | At delivery | 
| Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU |  | Up to 1 year post delivery | 
| Length of stay among all neonates (including NICU and nursery) |  | Up to 1 year post delivery | 
| Neonatal costs |  | Up to 1 year post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm Birth, Prematurity Prevention Clinic, Maternal-Fetal Medicine