FIT: Food in Twins. Diet in Twin Pregnancy: the Wellness of Mother and Babies.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- incidence of maternal obstetric complications:
研究概览
简要总结
The aim of this study is to evaluate how variations in maternal nutrition may affect twin pregnancy and in particular:
-
incidence of maternal obstetric complications:
-
gestational diabetes
-
gestational hypertension or preeclampsia
-
intrahepatic cholestasis (ICP)
-
fetal growth, development and birth weight of the babies
详细描述
Study design
At the time of recruitment, each patient will perform an initial clinical nutrition examination, during which will be evaluated, on the basis of BMI and specific anthropometric parameters, the necessary nutritional intake.
Patients included in the study will then be classified, on the basis of pre-pregnancy BMI, into 2 classes:
- normal weight (BMI 18-25)
- overweight (BMI 25-30) A specific diet will be developed for each patient, which will also take into account any food allergies or intolerances.
Each diet will be then eventually modified and revised throughout the pregnancy, according to the evolution of the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •dichorionic-diamniotic twin pregnancies
- •monochorionic-diamniotic twin pregrancies
- •monochorionic- monoamniotic twin pregnancies
- •spontaneous onset or by homologous PMA techniques
- •Age between 18 and 40 years
- •Gestational age between 8 weeks+0 days and 25 weeks+6 days
排除标准
- •Pregestational diabetes mellitus (type I and II)
- •Chronic hypertension
- •Previous bariatric surgery
- •Chronic gastrointestinal disease (Celiac disease, Crohn's disease, Ulcerative Rectocolitis)
- •Age less than 18 years or more than 40 years
- •Gestational age less than 8 weeks or more than 26 weeks
- •Fetal structural and/or genetic abnormalities
- •Heterologous PMA
- •Maternal eating disorders
- •Drug and/or alcohol use
- •Multiple pregnancies with more than two babies
结局指标
主要结局
incidence of maternal obstetric complications:
时间窗: From enrollment in the study to delivery
* gestational diabetes * gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)
次要结局
- fetal growth and birth weight of the babies(From enrollment in the study to delivery)
- maternal weight gain(From enrollment in the study to delivery)
- differences in early or late enrollment of patients(From enrollment in the study to delivery)
研究者
Visconti Daniela
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS