Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Completion Rate for First Trimester Scans
研究概览
简要总结
The purpose of this study is to assess the feasibility of ultrasound in the first trimester, assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess the completion rate of the combination of one ultrasound in the first trimester and one in the second trimesters compared to the individual completion rates of both evaluations in obese pregnant women.
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
- Single (Care Provider)
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
- •BMI greater than or equal to 35
- •Presented for ultrasound before 14 weeks at The University of Texas Professional Building, Memorial City, Bellaire, or Lyndon-Baines Johnson clinics
- •Primary language is English or Spanish
- •Consent to an extra transvaginal ultrasound if needed
- •Singleton gestation
- •No previous anomalies known before consent
- •Missed abortion (nonviable pregnancy)
排除标准
- •Elective abortion after recruitment
- •Missed abortion after first trimester ultrasound
- •Did not receive second trimester ultrasound
结局指标
主要结局
Completion Rate for First Trimester Scans
时间窗: 12-14 weeks of pregnancy
Completion rate is reported as the number of scans that see all the views divided by total number of scans in that group
Completion Rate for Second Trimester Scans
时间窗: 18-22 weeks of pregnancy
Completion rate is reported as the number of scans that see all the views divided by total number of scans.
次要结局
- Number of Participants With Infants Who Survive(9 months from randomization)
- Gestational Age at Delivery(at the time of delivery (about 40 weeks of pregnancy))
- Hospital Length of Stay(from time of hospital admission to discharge (about 0 to 365 days after birth))
- Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans(6 months from randomization)
- Completion Rate of First Trimester and Second Trimester Scans(12-22 weeks of pregnancy)
- Time Taken to Complete Scan in the First Trimester Ultrasound Group(12-14 weeks of pregnancy)
- Number of Participants With Infants With Neonatal Morbidities(9 months from randomization)
- Number of Anomalies Identified in First Trimester Group Scans(12-14 weeks of pregnancy)
- Number of Anomalies Identified in Second Trimester Group Scans(12-22 weeks of pregnancy)
- Number of Anomalies Missed in First Trimester Group Scans(12-14 weeks of pregnancy)
- Number of Anomalies Missed in Second Trimester Group Scans(12-22 weeks of pregnancy)
- Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)(at the time of NICU admission (about 0 to 28 days after birth))
- Cost of Intervention Compared to Usual Care(from 12-22 weeks of pregnancy)
研究者
Cara Buskmiller
Fellow
The University of Texas Health Science Center, Houston