Pregnancy Cohort Study: Pregnancy as a Window to Future Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorMedical University of Graz
About this trial
The goal of this observational cohort study is to gain deep insights into how metabolic disorders such as obesity or diabetes during pregnancy affect the metabolic and cardiovascular health of mother and child in the short and long term.
It will investigate the following questions:
* How do maternal metabolic disorders affect pregnancy outcomes? * How do maternal metabolic disorders affect fetal growth? * How do maternal metabolic disorders affect the newborn's metabolism and body composition? * How do maternal metabolic disorders during pregnancy affect breast milk composition? * How do maternal metabolic disorders during pregnancy affect the metabolic health of the mother after birth? Participants in this study are pregnant women who will be asked to come to the clinics for three visits during their pregnancy, as well as for the delivery of their baby, and one time 2-3 months thereafter. At each visit, researchers will perform physical examinations (such as body composition measurements) and collect biological samples (blood, urine, saliva), clinical information, and lifestyle data. At birth, researchers will collect cord blood and breast milk as well as clinical data of the delivery and the health of the baby. Researchers will measure body fat in newborn babies and at 2-3 months of age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ongoing pregnancy prior to 14th gestational week, women with child wish; above 18 years of age, giving informed consent
Disqualifiers
gestational age > 14th week of gestation; below 18 years of age; fetal genetic anomalies /malformation
Trial population
Eligible for participation are women with child wish and women with an on-going pregnancy who are planning to give birth at the university hospital in Graz, Austria. Women will be recruited as soon as possible in their pregnancy, but not after the 14th week of gestation. They will be recruited through the outpatient clinics and, in case of women with child wish, at the center for assisted reproductive technologies at the Department of Obstetrics and Gynecology, at Medical University Graz.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Maternal adiposity
Measured as fat mass and fat-free mass by air displacement plethysmography (via BODPOD) at 10-14 weeks, 20-24 weeks and 34-37 weeks of gestation and 8-12 weeks post partum.
Time frame
From enrolment to 8-12 weeks post partum2
Maternal fasting blood glucose
Fasting blood glucose as measured in mg/mL from NaF blood tubes at 10-14 weeks, 24-24 weeks, 34-37 weeks of gestation and 8-12 postpartum.
Time frame
from enrollment to 8-12 weeks postpartum3
Maternal blood pressure
Blood pressure will be measured at 10-14 weeks, 24-28 weeks and 34-37 weeks of gestation and 8-12 weeks post partum.
Time frame
From enrolment to 8-12 weeks postpartum4
Maternal lipid profiles - triglycerides
Analysis of serum lipid profiles: triglycerides at 3 time points during pregnancy (10-14 weeks (wks); 24-28wks; 34-37wks), and 8-12 wks postpartum.
Time frame
From enrolment to 8-12 weeks post partumSecondary outcomes
1
Human milk oligosaccharide (HMO) profile in maternal blood
HMOs will be analysed in maternal serum by high pressure liquid chromatography (HPLC) with fluorescence detection
Time frame
From enrolment to 8-12 weeks postpartum2
Human milk oligosaccharide (HMO) profile in maternal urine
HMOs will be analysed in maternal serum by high pressure liquid chromatography (HPLC) with fluorescence detection
Time frame
From enrolment to 8-12 weeks post partum3
Human milk oligosaccharide (HMO) profile in cord blood
HMOs will be analysed in umbilical cord blood serum by high pressure liquid chromatography (HPLC) with fluorescence detection
Time frame
at birth4
Human milk oligosaccharide (HMO) profile in breast milk
HMOs will be analysed in breast milk by high pressure liquid chromatography (HPLC) with fluorescence detection
Time frame
from child birth to 8-12 weeks postpartumOther outcomes
1
Maternal vaginal microbiome
From the extracted DNA, 16S rRNA genes will be amplified using specific primers for bacterial and archaeal communities. The amplicons obtained will be prepared for Illumina MiSeq Sequencing.
Time frame
From enrolment to 8-12 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov