Pregnancy Cohort Study: Pregnancy as a Window to Future Health

NCT06925815 | Recruiting

• 1 other identifier: 34-264 ex 21/22
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Pregnant Women; Obese Pregnant Women; Gestational Diabetes

Keywords

pregnancy; deep phenotyping; maternal metabolism; body composition; longitudinal pregnancy cohort study; fetal growth; obesity in pregnancy; neonatal adiposity; gestational weight gain; gestational diabetes; cardiovascular health

Outcome Measures

Primary Outcomes (17)

• 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.

  From enrolment to 8-12 weeks post partum

• 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.

  from enrollment to 8-12 weeks postpartum

• 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.

  From enrolment to 8-12 weeks postpartum

• 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.

  From enrolment to 8-12 weeks post partum

• Maternal lipid profiles: phospholipids

  Analysis of serum lipid profiles: phospholipids at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

  From enrolment to 8-12 weeks post partum

• Maternal lipid profiles: free fatty acids

  Analysis of serum lipid profiles: free fatty acids at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

  From enrolment to 8-12 weeks post partum

• Maternal lipid profiles: total cholesterol

  Analysis of serum lipid profiles: total cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

  From enrolment to 8-12 weeks post partum

• Maternal lipid profiles: HDL cholesterol

  Analysis of serum lipid profiles: HDL cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

  From enrolment to 8-12 weeks post partum

• Maternal lipid profiles: LDL cholesterol

  Analysis of serum lipid profiles: LDL cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

  From enrolment to 8-12 weeks post partum

• Maternal endothelial function

  measured as pulse wave velocity using a Vicorder®.

  From enrolment to 8-12 weeks post partum

• Maternal cytokine profile

  Serum cytokines will be analysed by multiplexing at all visits during pregnancy and postpartum.

  From enrolment to 8-12 weeks postpartum

• Gestational diabetes

  assessed through 75g 2h oral glucose tolerance test performed at 24-28 weeks of gestation.

  From enrolment to child birth; 6 months

• Hypertensive disorders of pregnancy

  gestational hypertension and preeclampsia, assessed through medical chart review.

  From enrolment to child birth; 6 months

• Neonatal body composition at birth

  Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)

  between delivery and 48h postpartum

• Neonatal C-peptide in cord blood

  Concentrations of C-peptide in cord blood

  at birth

• Neonatal cytokine profile

  Neonatal inflammatory cytokines will be measured in cord blood serum collected at birth using multiplexing cytokine assays.

  at birth

• Neonatal epigenetic profile

  Epigenomic profile of the umbilical cord blood measured by DNA methylation

  at birth

Secondary Outcomes (5)

• Human milk oligosaccharide (HMO) profile in maternal blood

  From enrolment to 8-12 weeks postpartum

• Human milk oligosaccharide (HMO) profile in maternal urine

  From enrolment to 8-12 weeks post partum

• Human milk oligosaccharide (HMO) profile in cord blood

  at birth

• Human milk oligosaccharide (HMO) profile in breast milk

  from child birth to 8-12 weeks postpartum

• Adverse pregnancy outcome

  From enrolment to child birth; 6 months

Other Outcomes (1)

• Maternal vaginal microbiome

  From enrolment to 8-12 weeks postpartum

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• ongoing pregnancy prior to 14th gestational week, women with child wish; above 18 years of age, giving informed consent

You may not qualify if:

• gestational age \> 14th week of gestation; below 18 years of age; fetal genetic anomalies /malformation

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Medical University of Graz

Graz, Styria, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

maternal samples: serum, ccfDNA (PAXgene), urine, saliva, vaginal swabs (at 14 wks, 24 wks and 37 wks of gestation, 8-12 wks post partum); cord blood samples: serum, ccfDNA (PAXgene); placenta and umbilical cord tissue; amniotic fluid (C-section); colostrum (48h postpartum); human milk (8-12 weeks post partum)

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy in Obesity; Gestational Weight Gain

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; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Study Officials

• Evelyn Jantscher-Krenn, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Herbert Fluhr, Univ.-Prof. Dr. med.

  Medical University of Graz

  STUDY DIRECTOR

• Ursula Hiden, Assoc. Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Christina Stern, Dr. med.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Federica Piani, MD, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Jantscher-Krenn, PhD

CONTACT

+43 316 385 80076; evelyn.jantscher-krenn@medunigraz.at

Christina Stern, Dr. med.

CONTACT

+43 316 385 86306; christina.stern@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: July 27, 2023
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2034
• Last Updated: April 13, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available starting 1 year after publication with no end date.
• Access Criteria: Data access will be provided to external researchers who submit a methodologically sound proposal for secondary data analysis that is approved by the study investigators and should be submitted to the study PI.

Locations

AU (1)