NCT03857659终止不适用
Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2019年4月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Number of participants with abnormal fetal growth or amniotic fluid
研究概览
简要总结
The purpose of this study us to compare the rate of prenatal identification of abnormal fetal growth or amniotic fluid between clinical evaluation of uterine size by symphysis fundal height (SFH) measurements versus point-of-care ultrasound (POC-US) evaluation of abdominal circumference (AC) and maximum vertical pocket (MVP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age of 18 at the time of consent
- •Singleton gestation
- •Ultrasound examination that confirms or revises the estimated date of delivery (EDD) before 22 0/7 weeks of gestational age
- •Gestational age ≥ 24 weeks gestation
排除标准
- •Abnormal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT)
- •Fetal chromosomal or genetic abnormalities
- •Fetal malformations or soft markers identified on fetal anatomy survey
- •Current pregnancy is a result of in vitro fertilization
- •Documented uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criterion.
- •Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelphus uterus), abnormal placentation (placenta previa, accrete, percreta), uterine fibroids.
- •Cerclage in the current pregnancy
- •History of intrauterine fetal demise
- •Fetal isoimmunization or alloimmunization
- •History of medical complications such as:
- •Cancer (including melanoma but excluding other skin cancers)
- •Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational).
- •Renal disease with altered renal function (creatinine > 0.9 or proteinuria)
- •Epilepsy or other seizure disorder
- •Any collagen disease (lupus erythematosus, scleroderma, etc.)
- •Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
- •Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb > 9 gm/dl). Patients with sickle cell disease are excluded.
- •Chronic pulmonary disease including asthma requiring regular use of medication and active tuberculosis (TB). An asthma inhaler used on an as needed basis (PRN) for a cold or an asthma attack is not considered regular use.
- •Heart disease except mitral value prolapse not requiring medication
- •Cardiovascular disorders: chronic hypertension
- •Liver disorders accounting for cholestasis
- •Infectious diseases: HIV, Cytomegalovirus (CMV), toxoplasmosis, parvovirus B19
结局指标
主要结局
Number of participants with abnormal fetal growth or amniotic fluid
时间窗: From 36 weeks Gestational age (GA) to 38.6 weeks GA
Abnormal fetal growth or amniotic fluid as assessed by formal ultrasound by RDMS
次要结局
- Specificity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Positive predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Negative predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Sensitivity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Sensitivity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- Specificity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- Positive predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- False positive rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- False negative rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- Negative predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- False positive rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Positive likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- False negative rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Positive likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- Negative likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
- Negative likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
- Number of referrals for formal USE.(From 28 weeks Gestational age (GA) to 36 weeks GA)
- Total costs of care from the health system perspective(from time of randomization until discharge (total time is about 15 weeks))
- Number of participants with composite neonatal morbidity(at delivery)
- Number of participants with composite maternal morbidity(labor until delivery (total time is about 1-48 hrs))
研究者
研究点 (2)
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