Clinical trial NCT02811172: Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol
Official title: Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Gestational Diabetes
Hypertension
Obesity
Keywords: Biological multi-paradigm model
Biomarkers
Triglycerides
Cholesterol
Prolactin
Glucose
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Exclusion criteria

* Impossibility to participate in the research.
* Restrictive pulmonary disease.
* Cardiac pathology with hemodynamic repercussion.
* Familiar hyperlipidemia.
* Multiple pregnancies.

Inclusion criteria

• Pregnant women healthy and with risk that want participate in a voluntary way in the research and sign the informed consent.

Primary outcomes:
measure: Triglyceride levels
timeFrame: 18 months
measure: prolactin levels
timeFrame: 18 months
measure: glucose levels
timeFrame: 18 months
measure: cholesterol levels
timeFrame: 18 months
measure: Nutritional evaluation
timeFrame: 3 months
measure: Collection of samples: mother's milk
timeFrame: 6 months
Secondary outcomes:
measure: Mother's milk: short-chain fatty acid
timeFrame: 6 months
measure: Mother's milk: Total fatty acid profile
timeFrame: 6 months
measure: Bioactive peptides
timeFrame: 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
References: