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

NCT02811172 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 224

Last updated 2019-02-25

No results posted yet for this study

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.

Conditions

Interventions

OTHER

BEhavior of biomarkers during pregnanCy and lactatiOn

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-08-31
Completion
2019-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811172 on ClinicalTrials.gov