PregnancyBECOMENCT02811172
Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol
An observational study of Pregnancy and Gestational Diabetes, run by Universidad de Granada at 1 site in Spain.
Trial summary
Background Despite of advances in research, at the moment, various points related to the physiology of gestation and the etiology of severe diseases that can be developed in the course of it remain unknown. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Diabetes, Hypertension
- What is being tested?
- BEhavior of biomarkers during pregnanCy and lactatiOn
- How many people
- 224 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Jan 2019
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The universe is composed by 4300 women that constitute the historical average of deliveries during a semester in the city of Granada (Spain). The research is projected over women that attend to the pregnancy control consultation into Granada's hospitals during the second semester of 2015. The sample is probabilistic and stratified. To calculate the size of the sample they were considered the characteristics of pregnant women that to be formed by 224 women that comply with the inclusion criteria and that sign the informed consent.
Who may be able to join
- Pregnant women healthy and with risk that want participate in a voluntary way in the research and sign the informed consent.
Who cannot join
- Impossibility to participate in the research.
- Restrictive pulmonary disease.
- Cardiac pathology with hemodynamic repercussion.
- Familiar hyperlipidemia.
- Multiple pregnancies.
Trial locations and contacts
1 site in 1 country.
About this study
Background Despite of advances in research, at the moment, various points related to the physiology of gestation and the etiology of severe diseases that can be developed in the course of it remain unknown. One of those aspects is the behavior of biomarkers (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few days before delivery. Several studies have reported that biomarkers experience a higher elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia. The description of their behavior in different population of pregnant women (healthy women and women at risk) would identify the relation of these with some of the alterations that occurs more frequently during pregnancy.
Objective The aim of this study is to develop a multi-paradigm biological model of systems to determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its relation with lactogenesis in healthy and risk pregnant women.
Read more
Methods A prospective cohort study will take place with women during pregnancy and lactation. Participating women will be divided into two groups. One group will be integrated by healthy women and the other group by pregnant women with a risk medical history. The personal, family and a detailed medical history will be collected in each group. A study of all the variables which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose and prolactin) will be done.
The universe consists in 4,300 women, who constitute the historical average deliveries during the semester in the city of Granada (Spain). The sample collection will be made in medical office's pregnancy control in Granada's hospitals, in their respective health centers and during the second half of 2015. The sample will be stratified and probabilistic. Peculiarities of pregnant women will be taken into account when calculating the size of the study sample. This sample will be made up of 224 women who comply with the inclusion criteria and that have signed the informed consent.
To achieve the project objectives an organization comprising six theoretical and practical phases enabling the scientific development of the project.
During the first phase, the technical and administrative preparation of the project is constructed. Thereafter, the work is divided into two action areas which encompass the collection and data modeling.
The creation of a biological multi-paradigm computer simulation model of the levels of biomarkers in different months of pregnancy and in the various pathologies of pregnant women can be very effective to know the risks that involve high levels of lipids for the mother and for the baby.
- Conditions
- Pregnancy, Gestational Diabetes, Hypertension, Obesity
- Being tested
- BEhavior of biomarkers during pregnanCy and lactatiOn
- Keywords
- Biological multi-paradigm model, Biomarkers, Triglycerides, Cholesterol, Prolactin, Glucose
- Medical subject headings
- Diabetes, Gestational, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEhavior of biomarkers during pregnanCy and lactatiOnOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | Healthy pregnant women Receives: Other: BEhavior of biomarkers during pregnanCy and lactatiOn | |
| Risk pregnant women | Hypertensive, obese and diabetic women Receives: Other: BEhavior of biomarkers during pregnanCy and lactatiOn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride levels
Begins in the 20 weeks and ended 20 days after delivery. Since the 37 week is taken each 72 hours and then daily when an increase of the values occurs and it's followed until 20 days after delivery.
Measures during this stage are performed with the reagent disk Piccolo®, using the blood analyzer Piccolo express™. It is designed for using in quantitative determination "in vitro" of the total cholesterol, High Density Lipoproteins and triglycerides in a clinic laboratory.
The levels of normality have been stablished to the following biomarkers:
Triglycerides levels: under 150 mg/dl, with a high limit between 155 and 199 mg/dl and higher between 200 and 499 mg/dl. During pregnancy it is recommended to keep it under 300 mg/dl.
Measured: 18 months
prolactin levels
Prolactin: 10- 209 ng/ml.
Measured: 18 months
glucose levels
Gestational diabetes: it is diagnose when in the O'Sullivan test the values are equal or superior to the following: blood sugar 105 mg/dl; 1 hour,190 mg/dl; 2 hours, 165 mg/dl and 3 hours, 145 mg/dl.
Measured: 18 months
cholesterol levels
To determine the values of total cholesterol, HDL, LDL and triglycerides the samples should be taken after 8 or 12 hours without eating.
The test begins after 10 minutes of transferring the sample to the disk. The levels of normality are:
Total cholesterol: under 200 mg/dl. LDL cholesterol: 40-60 mg/dl, values under 40 mg/dl indicate a higher risk of cardiovascular disease.
Measured: 18 months
Nutritional evaluation
In the first interview to the pregnant woman and after the sign of the informed consent the medical record is performed. Nutritional evaluation is carry out through a validate survey that was published in 2012 by our research team (González Jiménez et al., 2012).
Bioelectrical impedance was also performed. In clinical history socio demographics variables personal and familiars were collected and anxiety and depressive test were performed (Snaith \& Zigmond, 1983).
Measured: 3 months
Collection of samples: mother's milk
It is about to follow the evolution of the process of lactation and the quality of mother's milk. In each group of study three samples are collected: colostrum (2 to 6 days after delivery); transition milk (7 to 21 days after delivery) and maturing milk (after 21 days of delivery).
Lactogenesis is the process that begins with milk secretion. It is stablished between 24 hours and the sixth day after delivery and is a consequence of the action of prolactin and the low estrogenic level. Before delivery, PRL levels increase but the estrogens of placenta blocked the secretion of glands. The maintaining of lactation requires a continuous suction of the nipple. The estrogenic fall after delivery allows unblock or mammary tissue.
Measured: 6 months
Secondary outcomes (3)
Mother's milk: short-chain fatty acid
According technique developed by the Research Department of Nutrition and Food Science (Journal of Chemistry.2014 ) by gas chromatography using a Perkin Elmer Autosystem gas chromatograph ( Perkin -Elmer , Norwalk , CT , USA ) , equipped with a detector flame ionization (FID ) and a capillary column Supelco 2380 TVSS (30 m × 0.25 mm id , 0.2 um film thickness) .
Measured: 6 months
Mother's milk: Total fatty acid profile
Mass spectrometry using low resolution [ MSP ] with triple quadrupole analyzer (triple -quad ) WATERS model QUATTRO and micro GC Gas Chromatograph model 7890A AGILET , with injectors split / splitless and PTV for capillary columns . Servicos Central Scientific Instrumentation of the UGR ( http://cic.ugr.es/ )
Measured: 6 months
Bioactive peptides
For purification of the peptides the whey are subjected to ion exchange using Dowex 50WX2 resin in the column ( 2.6 x 10 cm , H + -form , 200-400 mesh , Serva , Heidelberg , Germany) according to the procedure described by Farvin et al., 2010 .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionAug 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
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
- NCT02811172
- Sponsor's protocol ID
- SPID201600X080546IV0
- Acronym
- BECOME
- Status last verified
- Feb 2019
- First submitted
- 17 May 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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
- Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol
- ClinicalTrials.gov ID
- NCT02811172
- Acronym / sponsor ID
- BECOME / SPID201600X080546IV0
- Conditions
- Pregnancy, Gestational Diabetes, Hypertension, Obesity
- Keywords
- Biological multi-paradigm model, Biomarkers, Triglycerides, Cholesterol, Prolactin, Glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- 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.
Background Despite of advances in research, at the moment, various points related to the physiology of gestation and the etiology of severe diseases that can be developed in the course of it remain unknown. One of those aspects is the behavior of biomarkers (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few days before delivery. Several studies have reported that biomarkers experience a higher elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia. The description of their behavior in different population of pregnant women (healthy women and women at risk) would identify the relation of these with some of the alterations that occurs more frequently during pregnancy.
Objective The aim of this study is to develop a multi-paradigm biological model of systems to determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its relation with lactogenesis in healthy and risk pregnant women.
Methods A prospective cohort study will take place with women during pregnancy and lactation. Participating women will be divided into two groups. One group will be integrated by healthy women and the other group by pregnant women with a risk medical history. The personal, family and a detailed medical history will be collected in each group. A study of all the variables which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose and prolactin) will be done.
The universe consists in 4,300 women, who constitute the historical average deliveries during the semester in the city of Granada (Spain). The sample collection will be made in medical office's pregnancy control in Granada's hospitals, in their respective health centers and during the second half of 2015. The sample will be stratified and probabilistic. Peculiarities of pregnant women will be taken into account when calculating the size of the study sample. This sample will be made up of 224 women who comply with the inclusion criteria and that have signed the informed consent.
To achieve the project objectives an organization comprising six theoretical and practical phases enabling the scientific development of the project.
During the first phase, the technical and administrative preparation of the project is constructed. Thereafter, the work is divided into two action areas which encompass the collection and data modeling.
The creation of a biological multi-paradigm computer simulation model of the levels of biomarkers in different months of pregnancy and in the various pathologies of pregnant women can be very effective to know the risks that involve high levels of lipids for the mother and for the baby.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | – | Other: BEhavior of biomarkers during pregnanCy and lactatiOnHealthy pregnant women |
| Risk pregnant women | – | Other: BEhavior of biomarkers during pregnanCy and lactatiOnHypertensive, obese and diabetic women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The universe is composed by 4300 women that constitute the historical average of deliveries during a semester in the city of Granada (Spain). The research is projected over women that attend to the pregnancy control consultation into Granada's hospitals during the second semester of 2015. The sample is probabilistic and stratified. To calculate the size of the sample they were considered the characteristics of pregnant women that to be formed by 224 women that comply with the inclusion criteria and that sign the informed consent.
Key inclusion criteria (1 listed)
- Pregnant women healthy and with risk that want participate in a voluntary way in the research and sign the informed consent.
Key exclusion criteria (5 listed)
- Impossibility to participate in the research.
- Restrictive pulmonary disease.
- Cardiac pathology with hemodynamic repercussion.
- Familiar hyperlipidemia.
- Multiple pregnancies.
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 |
|---|---|---|
| BEhavior of biomarkers during pregnanCy and lactatiOn | Other | Healthy pregnant women, Risk pregnant women |
Primary outcome
Triglyceride levels
Time frame: 18 months
Begins in the 20 weeks and ended 20 days after delivery. Since the 37 week is taken each 72 hours and then daily when an increase of the values occurs and it's followed until 20 days after delivery. Measures during this stage are performed with the reagent disk Piccolo®, using the blood analyzer Piccolo express™. It is designed for using in quantitative determination "in vitro" of the total cholesterol, High Density Lipoproteins and triglycerides in a clinic laboratory. The levels of normality have been stablished to the following biomarkers: Triglycerides levels: under 150 mg/dl, with a high limit between 155 and 199 mg/dl and higher between 200 and 499 mg/dl. During pregnancy it is recommended to keep it under 300 mg/dl.
prolactin levels
Time frame: 18 months
Prolactin: 10- 209 ng/ml.
glucose levels
Time frame: 18 months
Gestational diabetes: it is diagnose when in the O'Sullivan test the values are equal or superior to the following: blood sugar 105 mg/dl; 1 hour,190 mg/dl; 2 hours, 165 mg/dl and 3 hours, 145 mg/dl.
cholesterol levels
Time frame: 18 months
To determine the values of total cholesterol, HDL, LDL and triglycerides the samples should be taken after 8 or 12 hours without eating. The test begins after 10 minutes of transferring the sample to the disk. The levels of normality are: Total cholesterol: under 200 mg/dl. LDL cholesterol: 40-60 mg/dl, values under 40 mg/dl indicate a higher risk of cardiovascular disease.
Nutritional evaluation
Time frame: 3 months
In the first interview to the pregnant woman and after the sign of the informed consent the medical record is performed. Nutritional evaluation is carry out through a validate survey that was published in 2012 by our research team (González Jiménez et al., 2012). Bioelectrical impedance was also performed. In clinical history socio demographics variables personal and familiars were collected and anxiety and depressive test were performed (Snaith \& Zigmond, 1983).
Collection of samples: mother's milk
Time frame: 6 months
It is about to follow the evolution of the process of lactation and the quality of mother's milk. In each group of study three samples are collected: colostrum (2 to 6 days after delivery); transition milk (7 to 21 days after delivery) and maturing milk (after 21 days of delivery). Lactogenesis is the process that begins with milk secretion. It is stablished between 24 hours and the sixth day after delivery and is a consequence of the action of prolactin and the low estrogenic level. Before delivery, PRL levels increase but the estrogens of placenta blocked the secretion of glands. The maintaining of lactation requires a continuous suction of the nipple. The estrogenic fall after delivery allows unblock or mammary tissue.
3 secondary outcomes
Mother's milk: short-chain fatty acid
Time frame: 6 months
Mother's milk: Total fatty acid profile
Time frame: 6 months
Bioactive peptides
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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?
An observational study of Pregnancy and Gestational Diabetes, 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 1 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Triglyceride levels (time frame: 18 months). The study lists 6 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.