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

简要总结

详细描述

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.

主要结局

次要结局

• Length of stay among all neonates (including NICU and nursery)(Up to 1 year post delivery)
• Neonatal costs(Up to 1 year post delivery)
• 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)