NCT01606774
已完成
不适用
A Modernized Approach to Prenatal Care in Low Risk Women
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Pre-eclampsia
- 发起方
- Massachusetts General Hospital
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Unanticipated pregnancy complications
- 状态
- 已完成
- 最后更新
- 9年前
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.
研究者
Allan Nadel
Director of Prenatal Diagnosis, Dept. of OB/GYN
Massachusetts General Hospital
入排标准
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
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
研究点 (1)
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