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

U

University of Granada (UGR)

Status

Unknown

Conditions

Pregnant Woman With no Assisted Reproduction
Pregnant Woman With Single Pregnancy

Treatments

Other: Variability of the lipid profile in pregnant women

Study type

Interventional

Funder types

Other

Identifiers

NCT03496558
28/06/2017 UGR

Details and patient eligibility

About

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)

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

150 pregnant women with a history of risk
Experimental group
Treatment:
Other: Variability of the lipid profile in pregnant women
150 healthy pregnant women
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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