Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,873
- 试验地点
- 2
- 主要终点
- Neonatal Mortality Index
研究概览
简要总结
Background: 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 modalities.
Hypothesis: A cohort of pregnancies who are screened using the PreTRM® test around 20 weeks gestation in which a bundle of interventions is given for elevated PreTRM® risk will show either decreased neonatal morbidity/and mortality (measured as a composite score, "NMI"), or decreased length of neonatal stay in the hospital (NNOLOS). Secondarily, they will show an increase in gestational age at birth (GAB) and a reduction in length of neonatal NICU stay (NICULOS), compared to an unscreened historical control group.
Study Design Type: Prospective cohort study of screened women compared to a historical control of 10000 women.
详细描述
Population: Women who are 18 years or older, with a singleton pregnancy between 195/7 weeks and 206/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, and no history of prior preterm birth (delivery between 160/7 weeks and 366/7 weeks) will be invited to participate. A comparable population will be identified using a historical control group in a contemporaneously maintained database.
Intervention: Qualifying women 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 prespecified algorithm. The outcomes of these women will be compared to a historical control group at the same tertiary care center.
Outcomes:
Primary outcome: Co-Primary outcomes: To determine whether a cohort of women who are screened with the PreTRM® test and then managed according to a prespecified protocol will have statistically significant reductions in either (a) composite neonatal morbidity and mortality (NMI score), or (b) length of neonatal hospital stay (NNOLOS), compared to a historical control group. The NMI is defined below
DEFINITIONS OF COMPOSITE PERINATAL MORTALITY/NEONATAL MORBIDITY OUTCOME SCORES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18 years of age or older
- •Singleton intrauterine pregnancy
- •No medical contraindications to continuing pregnancy
- •Subject has no signs and/or symptoms of preterm labor and has intact membranes
- •Planned delivery at Christiana Care Health System,
- •English speaking as consents from other languages will not be provided.
排除标准
- •Women who have taken or plan to take progesterone beyond 14weeks gestation prior to study enrollment
- •Previous history of sPTB less than37 weeks gestation or PPROM less than34 weeks gestation
- •Multiple gestations-including a pregnancy that is now a single fetus due to a reduction procedure, vanishing twin, etc
- •Known fetal genetic anomalies that are incompatible with life. Examples would include trisomy 13 and trisomy
- •Others would be left to the discretion of the site investigators
- •Any other medical conditions that may be considered a contraindication per the judgment of the site investigator
- •The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
- •The subject has a planned cerclage placement for the current pregnancy
- •Major structural anomalies that may shorten pregnancy- examples would include anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia, pyloric stenosis, etc. Minor anomalies such as polydactyly, unilateral hydronephrosis are not viewed as exclusions. Others would be left to the discretion of the site investigators
- •History of cervical conization
- •The subject has a uterine anomaly, History of classical cesarean section in a previous pregnancy
- •The subject has had a blood transfusion during the current pregnancy
- •The subject has known elevated bilirubin levels (hyperbilirubinemia)
- •Previously identified short cervix (< 2.5 cm by TVUS)
- •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 or the subject has a history of allergic reaction to aspirin or progesterone.
结局指标
主要结局
Neonatal Mortality Index
时间窗: Birth through 6 months
Outcomes: Co primary outcomes will consist of the Neonatal Morbidity Index as defined by Hassan and Neonatal NICU length of stay
Neonatal NICU length of stay
时间窗: Birth to 6 months
Duration of hospitalization in the NICU
次要结局
- Preterm birth(Through pregnancy completion, typically 42 weeks)
- Total length of hospital stay for any preterm birth(From birth to 60 days post delivery)
研究者
Matthew Hoffman
Chair Department of OB/GYN
Christiana Care Health Services