NCT01606774已完成不适用
A Modernized Approach to Prenatal Care in Low Risk Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Unanticipated pregnancy complications
研究概览
简要总结
The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.
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
- — 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age < 35
- •Doesn't live alone
- •Current phone number
- •Previous pregnancy
- •No prior second trimester miscarriage/fetal loss after 13 weeks
- •Previous delivery
- •If yes, all had uncomplicated antepartum course
- •All Deliveries > 37 weeks
- •All birth weight > 2700 grams
- •Maternal BMI between 18.5 and 30
- •No chronic medical problems
- •No current substance abuse
- •Spontaneous conception
- •No family history of pre-eclampsia
- •Agrees to first trimester aneuploidy screening
排除标准
- •Clinically significant abnormalities on routine physical exam or routine laboratory results
- •Multiple pregnancy
- •Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency > 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
- •A risk of fetal aneuploidy on first trimester screening > 1:300 PAPP-A < 5 %ile or HCG < 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
- •Elevated blood pressure (> 140/90),
- •Cervical length < 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).
结局指标
主要结局
Unanticipated pregnancy complications
时间窗: Gestational age 18-36 weeks
Any maternal and/or fetal adverse outcome that was not detected, but could have been detected by routine antepartum visits between 18 and 36 weeks
次要结局
未报告次要终点
研究者
Allan Nadel
Director of Prenatal Diagnosis, Dept. of OB/GYN
Massachusetts General Hospital
研究点 (2)
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