Clinical trial NCT03496558: Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
Official title: Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Woman With Single Pregnancy
Pregnant Woman With no Assisted Reproduction
Keywords: lactogenesis, pregnant, TG, lipidic profile, breastfeeding.
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Measurement of biomarker prolactin.
timeFrame: 10 months
measure: Measurement of biomarker lipids
timeFrame: 10 months
Secondary outcomes:
measure: Anthropometric study.
timeFrame: 10 months
measure: nutritional study.
timeFrame: 10 months
measure: Family history of illness.
timeFrame: 10 months
measure: demographic variables
timeFrame: 10 months
measure: Personal history of illness.
timeFrame: 10 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granda
Study officials:
References: