Pregnant Woman With Single PregnancyPLELACTNCT03496558
Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
A study testing Variability of the lipid profile in pregnant women in people with Pregnant Woman With Single Pregnancy and Pregnant Woman With no Assisted Reproduction, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Woman With Single Pregnancy, Pregnant Woman With no Assisted Reproduction
- What is being tested?
- Variability of the lipid profile in pregnant women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2017to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant woman with single pregnancy
- Pregnant woman with no assisted reproduction
- Pregnant woman from 12-14 weeks of gestation.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read more
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)
Read the 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.
- Being tested
- Variability of the lipid profile in pregnant women
- Keywords
- lactogenesis, pregnant, TG, lipidic profile, breastfeeding.
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variability of the lipid profile in pregnant womenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 150 pregnant women with a history of risk | Experimental | Not described Receives: Other: Variability of the lipid profile in pregnant women |
| 150 healthy pregnant women | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 months
Secondary outcomes (5)
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
Measured: 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
Measured: 10 months
Family history of illness.
Compiled from clinical history
Measured: 10 months
demographic variables
Compiled from clinical history
Measured: 10 months
Personal history of illness.
Compiled from clinical history
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Feb 2017
- Primary completion25 Oct 2018
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Woman With Single PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Aguilar Cordero, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496558
- Sponsor's protocol ID
- 28/06/2017 UGR
- Acronym
- PLELACT
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model of Variability of the Lipid Profile in Pregnant Women and Its Relationship to lactogénesis
- ClinicalTrials.gov ID
- NCT03496558
- Acronym / sponsor ID
- PLELACT / 28/06/2017 UGR
- Keywords
- lactogenesis, pregnant, TG, lipidic profile, breastfeeding.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150 pregnant women with a history of risk | Experimental | Other: Variability of the lipid profile in pregnant women |
| 150 healthy pregnant women | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant woman with single pregnancy
- Pregnant woman with no assisted reproduction
- Pregnant woman from 12-14 weeks of gestation.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variability of the lipid profile in pregnant womenThe 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. | Other | 150 pregnant women with a history of risk |
Primary outcome
Measurement of biomarker prolactin.
Time frame: 10 months
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
Measurement of biomarker lipids
Time frame: 10 months
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
5 secondary outcomes
Anthropometric study.
Time frame: 10 months
nutritional study.
Time frame: 10 months
Family history of illness.
Time frame: 10 months
demographic variables
Time frame: 10 months
Personal history of illness.
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variability of the lipid profile in pregnant women in people with Pregnant Woman With Single Pregnancy and Pregnant Woman With no Assisted Reproduction, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of biomarker prolactin. (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.