An interventional study of Variability of the lipid profile in pregnant women in Pregnant Woman With Single Pregnancy and Pregnant Woman With no Assisted Reproduction, sponsored by Universidad de Granada. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Diagnostic
Among 35 studies in Breast Feeding with a site in Spain — 6 open to participants now, 9 under way, none of them phase 3. Breast Feeding · Spain.
Among the 35 studies in Breast Feeding with a site in Spain, this one is the 8th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2017, is one of 20 with no phase, and was the 12th registered.
1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.
Browse Breast Feeding studies →6 of the 35 studies in Breast Feeding with a site in Spain are open now. Recruiting first, the newest first:
Institut Investigacio Sanitaria Pere Virgili · Sites in Spain
Ages 18+ · Women only
Fundació Sant Joan de Déu · Sites in Spain
Ages 18–42 · Women only
Fundación Pública Galega de Investigación Biomédica INIBIC · Sites in Spain
Ages 18+ · Women only
Maimónides Biomedical Research Institute of Córdoba · Sites in Spain
Ages 0 days–120 days · Healthy volunteers
Instituto de Salud Carlos III · Sites in Spain
Healthy volunteers
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2 · Phase 4 2
First in 2002; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 100 across 845 interventional studies indexed under Breast Feeding.
Median enrollment 200 across the 25 interventional studies, 150 across the 10 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
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6 of 35 have an industry lead sponsor. The 10 most frequent:
Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
Universidad de Granada has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
3 of the studies in Breast Feeding with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07508917Fundació Sant Joan de DéuEffects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation | 2026-12-31 |
| NCT07635771Institut Investigacio Sanitaria Pere VirgiliDevelopment of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success. | 2027-06 |
| NCT07309510Fundación Pública Galega de Investigación Biomédica INIBICEffectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 35 studies in Breast Feeding with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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)
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: 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.
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
Time frame: 10 months
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
Time frame: 10 months
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
Time frame: 10 months
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
Time frame: 10 months
Family history of illness.
Compiled from clinical history
Time frame: 10 months
demographic variables
Compiled from clinical history
Time frame: 10 months
Personal history of illness.
Compiled from clinical history
Time frame: 10 months
Ran from Feb 2017 to primary completion in Oct 2018, 20 months.
Of 503 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 20 months is above that.
Counting every sponsor, half of 511 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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