Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-11 @ 4:48 AM
Study NCT ID:
NCT03496558
Status:
UNKNOWN
Last Update Posted:
2019-02-25
First Post:
2017-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
Sponsor:
Universidad de Granada
Organization:
Study Overview
Official Title:
Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLELACT
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)
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: