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

NCT02811172 | Completed DMC

• 1 other identifier: SPID201600X080546IV0
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Gestational Diabetes; Hypertension; Obesity

Keywords

Biological multi-paradigm model; Biomarkers; Triglycerides; Cholesterol; Prolactin; Glucose

Outcome Measures

Primary Outcomes (6)

• 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.

  18 months

• prolactin levels

  Prolactin: 10- 209 ng/ml.

  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.

  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.

  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).

  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.

  6 months

Secondary Outcomes (3)

• Mother's milk: short-chain fatty acid

  6 months

• Mother's milk: Total fatty acid profile

  6 months

• Bioactive peptides

  6 months

Study Arms (2)

Healthy pregnant women

Healthy pregnant women

Other: BEhavior of biomarkers during pregnanCy and lactatiOn

Risk pregnant women

Hypertensive, obese and diabetic women

Other: BEhavior of biomarkers during pregnanCy and lactatiOn

Interventions

BEhavior of biomarkers during pregnanCy and lactatiOn OTHER

Healthy pregnant women; Risk pregnant women

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• Impossibility to participate in the research.
• Restrictive pulmonary disease.
• Cardiac pathology with hemodynamic repercussion.
• Familiar hyperlipidemia.
• Multiple pregnancies.
• Pregnant women healthy and with risk that want participate in a voluntary way in the research and sign the informed consent.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Triglycerides; Cholesterol; Prolactin; Glucose; Human Milk.

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension; Obesity

Interventions

Lactation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 23, 2016
• Study Start: January 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)