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临床试验/NCT03496558
NCT03496558Unknown不适用

Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Measurement of biomarker prolactin.

研究概览

简要总结

The project that is presented to the ethical committee, from the initial program called BECOME (Behavior of biomarkers (lipid profile and prolactin) during pregnancy and lactation through a biological multi-paradigm model), which already requested and obtained the Suitability dated April 28, 2015. Based on it, the development of the current project will be the historical memory of FPU Research Fellow (October 2016) The determination of the lipid profile in pregnancy is performed through blood tests in each of the quarters.

A prospective cohort study will be conducted in women during pregnancy and lactation. From the first pregnancy visit until the child is six months old. Three prospectives (three annual series).

At least 60 healthy pregnant women and 60 women with a history of risk (20 for each risk) x 2 series (three years) will be tested, a total of 240-300 women to whom 5 analytical tests would have to be performed.

The researchers will take samples from the breastfeeding workshop of the study groups: Group 1 of healthy women and Group 2 of women with a history of risk (diabetes, overweight / obesity and hypertension)

详细描述

The project that is presented to the ethical committee, from the initial program called BECOME (Behavior of biomarkers (lipid profile and prolactin) during pregnancy and lactation through a biological multi-paradigm model), which already requested and obtained the Suitability dated April 28, 2015. Based on it, the development of the current project will be the historical memory of FPU Research Fellow (October 2016) The determination of the lipid profile in pregnancy is performed through blood tests in each of the quarters.

A prospective cohort study will be conducted in women during pregnancy and lactation. From the first pregnancy visit until the child is six months old. Three prospectives (three annual series).

At least 60 healthy pregnant women and 60 women with a history of risk (20 for each risk) x 2 series (three years) will be tested, a total of 240-300 women to whom 5 analytical tests would have to be performed.

The researchers will take samples from the breastfeeding workshop of the study groups: Group 1 of healthy women and Group 2 of women with a history of risk (diabetes, overweight / obesity and hypertension) Once all the data have been analyzed, a biological predictive model will be developed to establish its relationship with maternal alterations during pregnancy, as well as its relationship with lactogenesis in the last days of pregnancy. To this end, a computer program will be created where the personal, clinical and triglyceride levels of the pregnant woman will be obtained the results of the risk of altered triglycerides in the different months of gestation and the measures to be taken as a function of The same, as well as to identify the levels of triglycerides in the different maternal pathologies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant woman with single pregnancy
  • Pregnant woman with no assisted reproduction
  • Pregnant woman from 12-14 weeks of gestation.

排除标准

  • Pregnant woman with difficulty understanding the Spanish language
  • Pregnant woman who have been diagnosed clinically of a chronic disease prior to pregnancy
  • Pregnant woman who are under medical treatment (cancer, lung, kidney diseases , Hepatic, etc.).

研究组 & 干预措施

150 pregnant women with a history of risk

Experimental

干预措施: Variability of the lipid profile in pregnant women (Other)

150 healthy pregnant women

No Intervention

结局指标

主要结局

Measurement of biomarker prolactin.

时间窗: 10 months

2- 6 days of delivery: Samples of: Colostrum. 7 to 21 days: Transition milk samples. From day 21: Sample of mature milk. For each of the above samples, it will be determined: * LIPIDIC PROFILE Short Chain Fatty Acids * Profile (quantification) of Total Fatty Acids. COMPLEMENTARY PARAMETERS: TG, Cholesterol, and Glucose, by R-Biopharm® Enzyme Test. Prolactin

Measurement of biomarker lipids

时间窗: 10 months

A test that measures the amount of lipids, or fat, in the blood. The lipids measured are: total cholesterol, HLD cholesterol, LDL cholesterol, and triglycerides. Laboratory diagnostic performance (hypertriglyceridemia) * Cholesterol, triglycerides, HDL cholesterol and non-HDL cholesterol * Glucose, creatine, ALT, GGT, uric acid, TSH * Sedimentation and semiquantitative proteinuria. Album / creatine ratio * Apolipoprotein B * Genotype of apolipoprotein E

次要结局

  • demographic variables(10 months)
  • Family history of illness.(10 months)
  • Anthropometric study.(10 months)
  • nutritional study.(10 months)
  • Personal history of illness.(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María José Aguilar Cordero

Professor

Universidad de Granada

研究点 (2)

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