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

NCT ID: NCT03496558

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2020-02-29

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.

Conditions

Pregnant Woman With Single Pregnancy; Pregnant Woman With no Assisted Reproduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

150 pregnant women with a history of risk

Group Type: EXPERIMENTAL

Variability of the lipid profile in pregnant women

Intervention Type: OTHER

The women participants will be divided into two groups. Group 1 comprised of healthy women and group 2 by pregnant women with a history of risk. A personal, family history and a detailed medical history will be taken in each group. We will proceed to see all possible variables that influence the level of biomarkers (lipids and prolactin).

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

150 healthy pregnant women

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Variability of the lipid profile in pregnant women

The women participants will be divided into two groups. Group 1 comprised of healthy women and group 2 by pregnant women with a history of risk. A personal, family history and a detailed medical history will be taken in each group. We will proceed to see all possible variables that influence the level of biomarkers (lipids and prolactin).

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

Intervention Type: OTHER

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

María José Aguilar Cordero

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Granda

Granada, , Spain

Countries

Spain

Other Identifiers

28/06/2017 UGR

Identifier Type: -

Identifier Source: org_study_id