Pregnant Woman With no Assisted Reproduction Clinical Trial
— PLELACTOfficial title:
Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
| Verified date | February 2019 |
| Source | Universidad de Granada |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Active, not recruiting |
| Enrollment | 300 |
| Est. completion date | February 2020 |
| Est. primary completion date | October 25, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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.). |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universidad de Granda | Granada |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad de Granada |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of biomarker prolactin. | 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 |
10 months | |
| Primary | Measurement of biomarker lipids | 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 |
10 months | |
| Secondary | Anthropometric study. | Weight.- Size.- Seated size.- Triceps fold.- Biceps fold. -Subescapular fold.- Fold of ileocrestal.- Supraspinal fold.- Abdominal fold.- Axillary fold.-Folding pectoral.- Folding thigh frontal.- Fold leg Medial (calf) .- Perimeter of the relaxed arm.- Perimeter of the contracted arm.- Medial thigh perimeter.- Perimeter of the calf.- Diameter of the humerus.- Diameter of the wrist.- Diameter of the femur.- Diameter of the ankle | 10 months | |
| Secondary | nutritional study. | For the study of the diet will be used 3 types of questionnaires: Food register, in which the patient must record prior weighing or measurement, each and every one of the foods eaten during the day. Reminder Questionnaire 24 hours. By means of which, the interviewer will ask the patient everything she has eaten the day before, and the quantities ingested, for which it will be used a photo album of weights and rations prepared by professors of the Department of Nutrition and Bromatology of the Faculty of Pharmacy Frequency questionnaire of food consumption. By which the patient will indicate the times to the day, to the week, to the month or to the year that has consumed the food in the collected |
10 months | |
| Secondary | Family history of illness. | Compiled from clinical history | 10 months | |
| Secondary | demographic variables | Compiled from clinical history | 10 months | |
| Secondary | Personal history of illness. | Compiled from clinical history | 10 months |