Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol
Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol
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.
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.