Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)
研究概览
简要总结
The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy.
This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight.
Participants will be asked to complete:
- MRI in the second trimester (20-24 weeks)
- MRI in the third trimester (30-34 weeks)
详细描述
The transfer of oxygen and nutrients from the mother to the baby across the placenta is essential to successful pregnancy outcomes. Conversely, poor transfer of oxygen from the mother to the baby through the placenta is associated with adverse outcomes, including poor fetal growth, preterm delivery, and stillbirth. Babies need oxygen to maintain good health. Babies born to women who are obese before pregnancy have a higher risk of experiencing health problems in pregnancy and long-term health problems such as metabolic syndrome, obesity, and diabetes. Obesity has continued to increase in the United States over the past decades, and a quarter of pregnancy complications, such as preterm birth, gestational diabetes, hypertension, and large gestational infants, can be attributed to maternal obesity.
In this study, the investigators propose using a novel method, arterial spin labeling (ASL)) to measure placental blood flow. The study aims to evaluate the feasibility and reliability of assessing placental blood flow by this novel method. The investigators will also evaluate the mean global placental perfusion of second and third trimester placentas among obese women as compared to those with a normal weight before pregnancy. To provide an innovative and comprehensive evaluation of placental oxygen delivery and insights into the delivery of nutrients, investigators will compare global placental perfusion of second and third trimester placentas with measurements of placental oxygenation by R2* relaxation rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy, less than 24 weeks gestation
- •Pre-pregnancy BMI between 18.5 - 24.9kg/m2 or ≥30kg/m2
排除标准
- •Asthma on controller medication
- •Autoimmune Conditions
- •Chronic Hypertension
- •Claustrophobia
- •Congenital Anomaly
- •Pregestational Diabetes
- •History of Bariatric Surgery
- •Ineligible for MRI (incompatible implanted medical device)
- •Multifetal Gestation
- •Smoking during pregnancy
研究组 & 干预措施
Normal Weight
Body Mass Index (BMI) 18.5-24.9 kg/m^2
干预措施: functional Magnetic Resonance Imaging (fMRI) (Diagnostic Test)
Obese
Pre-pregnancy Body Mass Index (BMI) ≥ 30.0 kg/m^2
干预措施: functional Magnetic Resonance Imaging (fMRI) (Diagnostic Test)
结局指标
主要结局
Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)
时间窗: 6 weeks after the delivery
Evaluated using a two-way mixed intraclass correlation coefficient for consistency
Mean placental perfusion in second and third trimester
时间窗: 6 weeks after the delivery
The mean global placental perfusion of second and third-trimester placentas among participants with obesity (Body Mass Index measured in kg/m\^2, calculated using weight in kilograms and height in meters) as compared to those with a normal weight (kilograms) before pregnancy will be evaluated.
Mean R2* relaxation rates in second and third trimester
时间窗: 6 weeks after the delivery
the Mean R2\* relaxation rates will be used to correlate the global placental perfusion of second and third trimester placentas with measurements of placental oxygenation.
次要结局
- Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth.(6 weeks after the delivery)
研究者
Caitlin MacGregor
Physician, Fpa
Endeavor Health
