Impact of Maternal Left-Lateral Recumbent Positioning in Pregnancies With Fetal Growth Restriction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Fetal biometry
研究概览
简要总结
The goal of this clinical trial is to learn if maternal left-lateral positioning in pregnancy works to treat fetal growth restriction. This study will also help us learn about the effects of left-lateral positioning on maternal metabolomics, maternal mental health, fetal cardiac function, and delivery outcomes. The main questions it aims to answer are:
- Does maternal left-lateral position in a pregnancy with fetal growth restriction improve the baby's growth?
- How are maternal metabolomics, delivery outcomes, maternal mental health, and fetal cardiac function impacted by maternal left-lateral position? Researchers will compare the intervention group to pregnancies with fetal growth restriction that receive standard of care (without left-lateral positioning) to see if left-lateral position improves fetal biometry in fetal growth restriction.
Participants will:
- Practice left-lateral position every day for 4 hours (cumulatively) with 10-mins stretching after every hour of left-lateral position, or continue to receive standard of care
- Visit the clinic once after 4 weeks for a follow-up research visit, and at the time of delivery
Tracking of the physical activity and adherence to left-lateral position at home in intervention group A will be done through a fitbit (smart watch) given during enrollment. A fitbit will also be given to participants in intervention group B, receiving standard of care, to monitor their physical activity trends at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The sonographer doing the fetal biometry at enrollment and during the 4-week follow-up visit will be masked to the study group assigned to the participant.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant persons between 18 - 65 years of age, with a diagnosis of fetal growth restriction, with an estimated fetal weight less than tenth percentile
- •Participants with a singleton pregnancy between 24- and 34-weeks' gestational age
- •Participants with fluency in English or Spanish language
排除标准
- •Patients with a known history of deep vein thrombosis, pulmonary embolism, or hypercoagulability disorder
- •Patients with a pre-pregnancy BMI greater than 40
- •Pregnancy with severe abnormality in umbilical artery Doppler flow, including absent end-diastolic flow (AEDF) and reverse end-diastolic flow (REDF)
- •Patients receiving anticoagulation therapy
- •Pregnancy with suspected chromosomal anomalies or a multifetal pregnancy
- •Patients with an active smoking status during pregnancy
结局指标
主要结局
Fetal biometry
时间窗: 4 weeks after enrollment
Fetal estimated fetal weight and abdominal circumference will be assessed and compared to enrollment values
次要结局
- Fetal cardiac function(4 weeks after enrollment)
- Feto-Maternal Doppler flow(4 weeks after enrollment)
- Delivery outcomes(At delivery)
- Maternal Mental Health evaluation(4 weeks after enrollment, and after delivery)
- Maternal Metabolomics assessment(4 weeks after enrollment, and after delivery)